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By: Upton Sinclair

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While Wiley was stumping for a law, muckraking journalists such as Samuel Hopkins Adams exposed in vivid detail the hazards of the marketplace. In fact, the nauseating condition of the meat-packing industry that Upton Sinclair captured in The Jungle was the final precipitating force behind both a meat inspection law and a comprehensive food and drug law. (A poster of the 1913 movie adaptation of Sinclair's novel is pictured at right, courtesy of the Sinclair Archives, Lilly Library, Indiana University, through James Harvey Young's Pure Food: Securing the Federal Food and Drugs Act of 1906.) Since 1879, nearly 100 bills had been introduced in Congress to regulate food and drugs; on 30 June 1906 President Roosevelt signed the Food and Drugs Act, known simply as the Wiley Act, a pillar of the Progressive era.

This act, which the Bureau of Chemistry was charged to administer, prohibited the interstate transport of unlawful food and drugs under penalty of seizure of the questionable products and/or prosecution of the responsible parties. The basis of the law rested on the regulation of product labeling rather than pre-market approval. Drugs, defined in accordance with the standards of strength, quality, and purity in the United States Pharmacopoeia and the National Formulary, could not be sold in any other condition unless the specific variations from the applicable standards were plainly stated on the label. Foods were not defined according to analogous standards, but the law prohibited the addition of any ingredients that would substitute for the food, conceal damage, pose a health hazard, or constitute a filthy or decomposed substance. Interpretations of the food provisions in the law led to many, sometimes protracted, court battles. If the manufacturer opted to list the weight or measure of a food, this had to be done accurately. Also, the food or drug label could not be false or misleading in any particular, and the presence and amount of eleven dangerous ingredients, including alcohol, heroin, and cocaine, had to be listed.

The bureau's regulatory emphasis under Wiley centered on foods, which he believed posed a greater public health problem than adulterated or misbranded drugs. Wiley generally held a dim view of chemical additives to foods, championing an approach that considered most to be unnecessary adulterants. On this he clashed often with Secretary of Agriculture James Wilson, and on occasion President Roosevelt himself had to decide government policy on food regulation. Wiley's personal administrative authority under the act was diluted early on when Wilson created a Board of Food and Drug Inspection in 1907 to establish agency policy in enforcing the law. Similarly, the creation of the Referee Board of Consulting Scientific Experts in the following year to advise the department on safety issues associated with food additives undercut Wiley's scientific authority. The bureau had been developing informal standards for many foods in collaboration with outside experts since 1903, an activity that continued after the 1906 act. However, courts differed on the role these informal standards could play in cases. Separate laws established standards for some specific foods, such as apples and butter, as well as for canned foods.

Burton J. Howard, chief of the Bureau of Chemistry's microchemical laboratory, is shown in the right foreground in this photo from the 1920s. Howard developed a quantitative method to detect mold in ketchup that proved to be indispensable in establishing food adulteration in court.

After Wiley's resignation in 1912, the bureau devoted more effort to drug regulation, with some emphasis on the so-called patent medicines. While the law was much clearer about drug standards than standards for foods, misbranding was the source of considerable controversy in the regulation of drugs. A year earlier the Supreme Court ruled that the law did not--contrary to the government's interpretation--apply to false therapeutic claims. An amendment in the year of Wiley's resignation attempted to correct the language of the law. But it put the bureau in the difficult position of attempting to prove in court that manufacturers of drugs labeled with false therapeutic claims intended to defraud consumers. The bureau lost several cases against egregious products, but seizures of misbranded and adulterated drugs nevertheless increased in the 1920s and 1930s.
Next: The 1938 Food, Drug, and Cosmetic Act

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Part I: The 1906 Food and Drugs Act and Its Enforcement

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While Wiley was stumping for a law, muckraking journalists such as Samuel Hopkins Adams exposed in vivid detail the hazards of the marketplace. In fact, the nauseating condition of the meat-packing industry that Upton Sinclair captured in The Jungle was the final precipitating force behind both a meat inspection law and a comprehensive food and drug law.

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541 Remarks Upon Signing Bill Amending the Meat Inspection Act. December 15...: EBSCOhost

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After you look at these images of meat-packing facilities from early last century, you'll understand why social reformer Upton Sinclair wrote his great 1906 novel about workers' horrific experiences in the meat packing industry.

The mince meat department in Armour's great packing house, Chicago, c. 1893

(via Library of Congress)

A Half Mile of Pork, at Armour's Great Packing House in Chicago, around 1894
(via Library of Congress)
Workers

The old Union Stockyards in Chicago, early 1900s

Cutting up hogs in Swift & Co.'s Packing House, c. 1905
(via Library of Congress)
Making link sausages with machines that could stuff 10 ft. per second, c. 1905
(via Library of Congress)
Washing and tagging freshly killed lamb, 1906
(via Library of Congress)
Knocking cattle before slaughtering, 1906
(via Library of Congress)
A slaughterhouse in Canada, around 1907
(via Library and Archives Canada)
Cutting up meat in a German packing house
(via Library of Congress)
Packing sliced bacon in glass jars, c. 1909
(via Library of Congress)
As a lamb to the slaughter, photo by George Boston Brayton, c. 1913
(via Library of Congress)
Chicago meatpacking plant workers, 1905

Pen of hogs at William Davies Company, a photo by William James Topley, 1920s
(via Library and Archives Canada)
A butcher inspects a rack of hams, c. 1928

(Photo by Three Lions/Getty Images)

Cattle are first led into a narrow alley and stunned by a blow on the head, in a packing plant in Austin, Minnesota, 1941
(via Library of Congress)
Heads of beef cattle, Austin, Minnesota, 1941
(via Library of Congress)

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Utterly Disturbing, Century-Old Photos of Meat-Packing Facilities

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After you look at these images of meat-packing facilities from early last century, you'll understand why social reformer Upton Sinclair wrote his great 1906 novel about workers' horrific experiences in the meat packing industry. The mince meat department in Armour's great packing house, Chicago, c.

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Toggle the table of contents

From Wikipedia, the free encyclopedia

Acronyms (colloquial)

PFDA

Enacted by

the 59th United States Congress

Effective

January 1, 1907

Public law
59-384

Statutes at Large

34 Stat. 768, Chapter 3915

Acts repealed

Pure Food and Drug Act (1906)

37 U.S. Stat. 416 (1912) (Sherley Amendment)

37 U.S. Stat. 732 (1913) (Gould Amendment)

41 U.S. Stat. 271 (1919) (Kenyon Amendment)

42 U.S. Stat. 1500 (1923)

44 U.S. Stat. 976-1003 (1927)

46 U.S. Stat. 1019 (1930) (McNary-Mapes Amendment)

48 U.S. Stat. 1204 (1934) (21 U.S.C. §§ 1-15)

Titles amended
21 U.S.C.: Food and Drugs

Introduced in the Senate as S. 88 by Weldon Heyburn (R-ID) on December 14, 1905

Passed the Senate on February 30, 1906 (63-4)

Passed the House on June 20, 1906 (143-72)

Reported by the joint conference committee on June 23, 1906; agreed to by the House on June 23, 1906 (Did not agree) and by the Senate on June 23, 1906 (241-17)

Signed into law by President Theodore Roosevelt on June 30, 1906

Food, Drug, and Cosmetic Act (1938)
Food Quality Protection Act (1996)

United States v. Johnson (1911)

The Pure Food and Drug Act of 1906, also known as Dr. Wiley's Law, was the first of a series of significant consumer protection laws which was enacted by Congress in the 20th century and led to the creation of the Food and Drug Administration. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug's packaging and that drugs could not fall below purity levels established by the United States Pharmacopeia or the National Formulary.

In the late 1800s, the quality of food in the United States decreased significantly as populations moved to cities and the time from farm to market increased. Many food producers turned to using dangerous preservatives, even formaldehyde, to keep food fresh. Simultaneously, the quality of medicine was abysmal. Quack medicine was frequent, and many drugs were addictive or dangerous without actually providing a curative effect. Opium and alcohol were chief ingredients, even in infant medicines. The work of muckraking journalists exposed the horrific practices of both industries and caused public outcry.

Foremost among such exposés was The Jungle by Upton Sinclair, published the same year as the act. With its graphic and revolting descriptions of unsanitary conditions and unscrupulous practices rampant in the meatpacking industry, it was an inspirational piece that kept the public's attention on the important issue of unhygienic meat processing plants. Sinclair quipped, "I aimed at the public's heart and by accident I hit it in the stomach," as outraged readers demanded and got the Pure Food and Drug Act, as well as the 1906 Federal Meat Inspection Act.[1]

The Pure Food and Drug Act of 1906 was a key piece of Progressive Era legislation, signed by President Theodore Roosevelt on the same day as the Federal Meat Inspection Act. Enforcement of the Pure Food and Drug Act was assigned to the Bureau of Chemistry in the U.S. Department of Agriculture which was renamed the U.S. Food and Drug Administration (FDA) in 1930. The Meat Inspection Act was assigned to what is now known as the Food Safety and Inspection Service, which remains in the U.S. Department of Agriculture. The first federal law regulating foods and drugs, the 1906 Act's reach was limited to foods and drugs moving in interstate commerce. Although the law drew upon many precedents, provisions, and legal experiments pioneered in individual states, the federal law defined "misbranding" and "adulteration" for the first time and prescribed penalties for each. The law recognized the U.S. Pharmacopeia and the National Formulary as standards authorities for drugs, but made no similar provision for federal food standards.[2] The law was principally a "truth in labeling" law designed to raise standards in the food and drug industries and protect the reputations and pocketbooks of honest businessmen.

Under the law, drug labels, for example, had to list any of 10 ingredients that were deemed "addictive" and/or "dangerous" on the product label if they were present, and could not list them if they were not present. Alcohol, morphine, opium, and cannabis were all included on the list of these "addictive" and/or "dangerous" drugs. The law also established a federal cadre of food and drug inspectors that one Southern opponent of the legislation criticized as "a Trojan horse with a bellyful of inspectors and other employees."[3] Penalties under the law were modest, but an under-appreciated provision of the Act proved more powerful than monetary penalties. Goods found in violation of various areas of the law were subject to seizure and destruction at the expense of the manufacturer. That, combined with a legal requirement that all convictions be published as Notices of Judgment, proved to be important tools in the enforcement of the statute and had a deterrent effect upon would-be violators.[4]

Deficiencies in this original statute,[example needed ] which had become noticeable by the 1920s, led to the replacement of the 1906 statute with the Federal Food, Drug, and Cosmetic Act which was enacted in 1938 and signed by President Franklin Roosevelt. This act, along with its numerous amendments, remains the statutory basis for federal regulation of all foods, drugs, biological products, cosmetics, medical devices, tobacco, and radiation-emitting devices by the U.S. Food and Drug Administration.

An 1882 article in Scientific American describes "New Laws for Analyzing Food and Drugs" and highlights historical aspects.[5] Part of the draft stated:

"An article shall be deemed to be adulterated within the meaning of this act.

A.-In the case of drugs:
* If, when sold under or by a name recognized in the United States Pharmacopeia, it differs from the standard of strength, quality, or purity laid down in such work.
* If when sold under or by a name not recognized in the United States Pharmacopeia, but which is found in some other pharmacopeia or ether standard work on materia medica, it differs from the standard of strength, quality, or purity laid down in such work.
* If its strength or purity fall below the professed standard under which it is sold

B.-In the case of food or drink:
* If any substance or substances has or have been mixed with it as to reduce or lower or injuriously affect its quality of strength
* If any inferior or cheaper substance or substances have been substituted wholly or in part for the article
*If any valuable constituent of the article has been wholly or is part abstracted
* If it be an imitation of or be sold under the name of another article
* If it consists wholly or in part of a diseased or decomposed, or putrid or rotten, animal or vegetable substance, whether manufactured or not, or in the case of milk, if it is the produce of a diseased animal
* If it be colored, or coated, or polished, or powdered, whereby damage is concealed, or it is made to appear better than it really is, or of greater value"

― Scientific American, 7 Jan 1882[5]

It took 27 years to adopt the 1906 statute, during which time the public was made aware of many problems with foods and drugs in the U.S. Muckraking journalists, such as Samuel Hopkins Adams, targeted the patent medicine industry with its high-alcoholic content patent medicines, soothing syrups for infants with opium derivatives, and "red clauses" in newspaper contracts providing that patent medicine ads (upon which most newspapers of the time were dependent) would be withdrawn if the paper expressed support for food and drug regulatory legislation.

The Chief Chemist of the Bureau of Chemistry, Dr. Harvey Washington Wiley, captured the country's attention with his hygienic table studies, which began with a modest Congressional appropriation in 1902. The goal of the table trial was to study the human effects of common preservatives used in foods during a period of rapid changes in the food supply brought about by the need to feed cities and support an industrializing nation increasingly dependent on immigrant labor. Wiley recruited young men to eat all their meals at a common table as he added increased "doses" of preservatives including borax, benzoate, formaldehyde, sulfites, and salicylates. The table trials captured the nation's fancy and were soon dubbed "The Poison Squad" by newspapers covering the story. The men soon adopted the motto "Only the Brave dare eat the fare" and at times the publicity given to the trials became a burden. Though many results of the trial came to be in dispute, there was no doubt that formaldehyde was dangerous and it disappeared quickly as a preservative. Wiley himself felt that he had found adverse effects from large doses of each of the preservatives and the public seemed to agree with Wiley. In many cases, most particularly with ketchup and other condiments, the use of preservatives was often used to disguise insanitary production practices. Although the law itself did not proscribe the use of some of these preservatives, consumers increasingly turned away from many products with known preservatives.

The 1906 statute regulated food and drugs moving in interstate commerce and forbade the manufacture, sale, or transportation of poisonous patent medicines.[6] The Act arose due to public education and exposés from public interest guardians such as Upton Sinclair and Samuel Hopkins Adams, social activist Florence Kelley, researcher Harvey W. Wiley, and President Theodore Roosevelt.

The 1906 Act paved the way for the eventual creation of the Food and Drug Administration (FDA) and is generally considered to be that agency's founding date, though the agency existed before the law was passed and was not named FDA until later. "While the Food and Drug act remains a foundational law of the FDA mission, it's not the law that created the FDA. [Initially,] the Bureau of Chemistry (the precursor to the FDA) regulated food safety. In 1927, the Bureau was reorganized into the Food, Drug, and Insecticide Administration and the Bureau of Chemistry and Soils. The FDIA was renamed the FDA in 1930."[7]

The law itself was largely replaced by the much more comprehensive Federal Food, Drug, and Cosmetic Act of 1938.

The Pure Food and Drug Act was initially concerned with ensuring products were labeled correctly. Later efforts were made to outlaw certain products that were not safe, followed by efforts to outlaw products which were safe but not effective. For example, there was an attempt to outlaw Coca-Cola in 1909 because of its excessive caffeine content; caffeine had replaced cocaine as the active ingredient in Coca-Cola in 1903.[8] In the case United States v. Forty Barrels and Twenty Kegs of Coca-Cola, the judge found that Coca-Cola had a right to use caffeine as it saw fit, although Coca-Cola eventually lost when the government appealed to the Supreme Court.[9] It reached a settlement with the United States government to reduce the caffeine amount.

In addition to caffeine, the Pure Food and Drug Act required that drugs such as alcohol, cocaine, heroin, morphine, and cannabis, be accurately labeled with contents and dosage. Previously many drugs had been sold as patent medicines with secret ingredients or misleading labels. Cocaine, heroin, cannabis, and other such drugs continued to be legally available without prescription as long as they were labeled. It is estimated that sale of patent medicines containing opiates decreased by 33% after labeling was mandated.[10] The Pure Food and Drug Act of 1906 is cited by drug policy reform advocates such as Jim Gray as a successful model for re-legalization of currently prohibited drugs by requiring accurate labels, monitoring of purity and dose, and consumer education.[11]

1. Arlene F. Kantor, "Upton Sinclair and the Pure Food and Drugs Act of 1906: 'I aimed at the public's heart and by accident I hit it in the stomach,'" ^ American Journal of Public Health 66.12 (1976): 1202-1205.

2. ^ Swann, Ph.D., John P. "The 1906 Food and Drugs Act and Its Enforcement". FDA History - Part I. U.S. Food and Drug Administration.

3. Young, James H. ^ Pure Food: Securing the Federal Food and Drugs Act of 1906. Princeton, N.J: Princeton University Press, 1989, p. 98.

4. ^ FDA Notices of Judgment Collection, 1908-1966

5. ^ a Scientific American. Munn & Company. January 7, 1882. p. 2. b

6. ^ Ayers, Edward A. (August 1907). "What The Food Law Saves Us From: Adulterations, Substitutions, Chemical Dyes, and Other Evils". The World's Work: A History of Our Time. XIV: 9316-9322.

7. ^ "Milestones in U.S. Food and Drug Law History - Significant Dates in U.S. Food and Drug Law History". www.fda.gov.

8. ^ Hamblin M.D., James (January 31, 2013). "Why We Took Cocaine Out of Soda". The Atlantic Monthly. The Atlantic's Health Editorial.

9. "^ Pop psychology: The man who saved Coca-Cola", by Ludy T. Benjamin, Monitor on Psychology, February 2009, Vol 40, No. 2, p. 18

10. ^ Musto, David F. (1999). The American Disease: Origins of Narcotic Control (3rd ed.). Oxford University Press. ISBN 0-19-512509-6.

11. ^ Gray, James P. (May 2, 2001). Why Our Drug Laws Have Failed and What We Can Do About It: A Judicial Indictment of the War on Drugs. Temple University Press. pp. 288. ISBN 978-1566398602.

Sources

Barkan, I. D. (January 1985). "Industry invites regulation: the passage of the Pure Food and Drug Act of 1906". American Journal of Public Health. 75 (1): 18-26. doi:10.2105/AJPH.75.1.18. PMC 1646146. PMID 3881052.

The State of Connecticut. Connecticut Agricultural & Experiment Station Annual Reports. New Haven. For years preceding and following passage of the Act:

Dunn, Arthur Wallace (September 1911). "Dr. Wiley And Pure Food, First Article: A Twenty-Year's Fight, The Long Struggle Against "Influence" to Enact the Law, The Harder Struggle to Enforce It, An Amazing Story of Obstruction". The World's Work: A History of Our Time. XXII: 14958-14965.

Dunn, Arthur Wallace (November 1911). "Dr. Wiley and Pure Food, Second Article: The Chief of the Bureau of Chemistry as Washington Knows Him". The World's Work: A History of Our Time. XXIII: 29-40.

Greeley, Arthur Philip (1907). The Food and Drugs Act, June 30, 1906: A Study with Text of the Act, Annotated, the Rules and Regulations for the Enforcement of the Act, Food Inspection, Decisions and Official Food Standards. Washington, D.C.: J. Byrne & Company.

James Harvey Young, Pure Food: Securing the Federal Food and Drugs Act of 1906 (New Jersey: Princeton University Press, 1989).

Mitchell Okun, Fair Play in the Marketplace: The First Battle for Pure Food and Drugs (Dekalb: University of Illinois Press, 1986).

Suzanne White Junod, Chemistry and Controversy: Food Additive Regulation, unpublished dissertation, Emory University, 1994.

Andrew F. Smith, Pure Ketchup: A History of America's National Condiment (Columbia: University of South Carolina Press, 1996)

Goodwin, Pure Food, Drug, and Drink Crusaders

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Toggle the table of contents From Wikipedia, the free encyclopedia Acronyms (colloquial) PFDA Enacted by the 59th United States Congress Effective January 1, 1907 Public law 59-384 Statutes at Large 34 Stat. 768, Chapter 3915 Acts repealed Pure Food and Drug Act (1906) 37 U.S. Stat. 416 (1912) (Sherley Amendment) 37 U.S.

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"The Jungle," a harrowing account of a Lithuanian immigrant's experience laboring in Chicago's meatpacking industry, was serialized in the Socialist magazine Appeal to Reason in 1905 before the installments were collected and published as a book in 1906. It came on the heels of exposés by the press and after months of reporting in Chicago's Packingtown, as the neighborhood around the stockyards was known, by Sinclair himself.

"The Jungle's" grotesque descriptions of conditions endured by workers and livestock, and the contaminated food that came of them, made it a runaway hit and catalyzed the public's fear and fury.

There were cattle which had been fed on "whiskey-malt," the refuse of the breweries, and had become what the men called "steerly" - which means covered with boils. It was a nasty job killing these, for when you plunged your knife into them they would burst and splash foul-smelling stuff into your face; and when a man's sleeves were smeared with blood, and his hands steeped in it, how was he ever to wipe his face, or to clear his eyes so that he could see?

The book eventually sold millions of copies, was translated into dozens of languages and cemented Sinclair's reputation as a crusader for social justice. It remains an inspiration to journalists investigating the food industry and food health scares, workplace conditions and the environmental impact of industry.

Sinclair later said that his readers had missed the point by focusing on the health risks created by unsanitary stockyards and meatpacking facilities rather than on the dehumanization of workers and the brutal treatment of animals.

"I aimed at the public's heart," he said, "and by accident I hit it in the stomach."

Still, Sinclair was quick to harness the reaction. About a month after "The Jungle" was published, the White House started receiving "100 letters a day demanding a Federal cleanup of the meat industry," Alden Whitman wrote in Sinclair's obituary. (He died on Nov. 25, 1968.)

Roosevelt invited Sinclair to the White House, then ordered a federal investigation. Sinclair took every opportunity to harangue the Beef Trust, as the meatpacking industry was known, and sent a stream of telegrams to the White House demanding reform. Roosevelt soon tired of Sinclair's outspokenness. In a note to the author's publisher, the president wrote, "Tell Sinclair to go home and let me run the country for a while."

Sinclair did no such thing. In some 90 books and innumerable articles over the next six decades, he pushed for progressive causes, like "strong trade unions, abolition of child labor, birth control, Prohibition, utopian Socialism, an honest press, morality in business and industry, vegetarianism, mental telepathy and spiritualism, educational reform and civil liberties," his obituary said. He won the 1943 Pulitzer Prize for his novel "Dragon's Teeth," which dramatized the Nazi takeover of Germany during the 1930s.

Fame from "The Jungle" lasted until the end of Sinclair's life. He was invited to the White House again in 1967, the year before his death, to witness the signing of a new food safety law by President Lyndon B. Johnson.

Robin Williams, an indefatigable, improvisational genius, arrived on screens as an alien and left as an Academy Award-winning actor.

After his death, two years ago today, The New York Times described him like this:

Onstage he was known for ricochet riffs on politics, social issues and cultural matters both high and low; tales of drug and alcohol abuse; lewd commentaries on relations between the sexes; and lightning-like improvisations on anything an audience member might toss at him. His gigs were always rife with frenetic, spot-on impersonations that included Hollywood stars, presidents, princes, prime ministers, popes and anonymous citizens of the world. His irreverence was legendary and uncurtailable.

We remember Williams with some of our favorite scenes and lines (some of which contain strong language), and encourage readers to do the same on Twitter using #tellnyt.

Williams broke through to mainstream audiences on this quirky sitcom, in which he played Mork from Ork, a sweet, goofy alien who befriends a young Colorado woman.

Williams earned an Academy Award nomination for playing Adrian Cronauer, a chatty Armed Forces Radio host in Saigon in the 1960s. "This is the first role that calls upon me to do what I do best - me," he said.

He voiced an unforgettably zany blue genie in the 1992 Walt Disney feature.

Williams played an actor who cross-dressed as a British housekeeper to spend more time with his children in this 1993 family comedy.

Williams's Oscar-winning turn as a therapist working with a troubled prodigy, played by Matt Damon, offered him a rare serious role that took advantage of his wide-ranging talents.

Williams starred in this black comedy as Rainbow Randolph, a children's TV show host who is fired for taking bribes and replaced by an upstanding performer played by Edward Norton.

On Kate Winslet's head piece: "The nice thing about this hat is that it covers up the head wound that made her think it was a good idea to wear it in the first place."

On Queen Elizabeth II: "Gowns by Helen Keller. Nice looking. Not at all like her stamp. Wears her watch over the glove, though - tacky."

On Donatella Versace: "That skin! She looks like something you'd hang off your door in Africa."

On herself: "My love life is like a piece of Swiss cheese; most of it's missing, and what's there stinks."

Joan Rivers, the irrepressible and sharply acerbic comedian, would have been 83 today, and since her death almost two years ago, she has left a celebrity-skewering void that can still be felt during every major red carpet event, from the Oscars to the Grammys, where the glitterati were sitting ducks for her as she hosted the E! show "Fashion Police."

As Katy Perry tweeted on the day Ms. Rivers died:

What's the point of wearing all these dumb costumes if Joan's not here to rip them apart RIP Joan Rivers. You are a one of a one. katyperry

(Ms. Rivers died undergoing a routine procedure in New York City. A settlement in a malpractice lawsuit filed by Ms. Rivers's daughter, Melissa, was reached in May.)

In honor of her birthday, we're asking readers to share their favorite zingers and one-liners by Ms. Rivers on Twitter using #TellNYT.

But beyond the red carpet, we remember Ms. Rivers today as one of America's first successful female stand-up comics in a landscape dominated by men. She paved the way for generations of comedians, distinguishing herself with slashing style and biting self-deprecation, even about her death.

"I've had so much plastic surgery," she once said. "When I die they will donate my body to Tupperware."

Ms. Rivers broke through in the 1960s as a guest on "The Tonight Show" with Johnny Carson. A review in The New York Times in 1965 called her "an unusually bright girl who is overcoming the handicap of a woman comic, looks pretty and blonde and bright and yet manages to make people laugh."

But she was fired after she got her own show. Then her husband committed suicide. Driven by despair and desperation, she reinvented herself as a writer, producer and entrepreneur. In the 1990s she began "poking a microphone into freshly Botoxed faces on red carpets," and in 2010 she became a star of "Fashion Police." Nothing was sacred. No one was spared.

The Times obituary said:

"She would take the stage in a demure black sheath and ladylike pearls, a tiny bouffant blonde with a genteel air of sorority decorum. Then she'd stick her finger down her throat and regurgitate the dirt on the rich and famous, the stream-of-consciousness take on national heroes and sacrosanct cultural idols."

If you could have dinner with one person who is no longer with us, and whose obituary was published in The New York Times, who would it be, and why that person? Not Forgotten is asking that question of a variety of influential people this summer in a series of posts called Breaking Bread.
First up is Cory Booker, New Jersey's junior senator, a former mayor of Newark and a Democrat frequently mentioned as a potential vice-presidential running mate in the 2016 election.

Asked in a telephone interview on Wednesday to choose a dinner companion, Mr. Booker said he had gone back and forth between two of his heroes, both of whom rose from slavery: Harriet Tubman, the abolitionist who is most remembered for ushering dozens of slaves to freedom along the Underground Railroad, and Frederick Douglass, the abolitionist author and orator and later prominent humanitarian and campaigner for women's rights.

Mr. Booker said he keeps a statue of Tubman and a picture of Douglass in his office.

The Douglass picture, he said, is "a constant reminder to me of the idea of lifelong service, of tireless, unyielding dedication to the ideals of our nation, and to his understanding that our nation's ideals of freedom and liberty can't just be fought for once in a while."

In the end he chose Douglass.

"He's just somebody who had a profound regality about him and a pervasive humility," Mr. Booker said. "And the way he engaged himself, and one of the last things he did before he died was going to a suffrage movement meeting."

The meeting was of the Women's National Council at Metzerott Hall in Washington. An honored guest, Douglass was escorted to the platform by the suffragettes Susan B. Anthony and Anna H. Shaw, The Times reported. Shortly after the meeting, on Feb. 20, 1895, he collapsed and died at his home in the capital while he and his wife waited for a carriage to take him to Hillsdale African Church, where he was to give a lecture. He was 78.

"It is a singular fact, in connection with the death of Mr. Douglass," The Times wrote in its obituary, "that the very last hours of his life were given in attention to one of the principles to which he has devoted his energies since his escape from slavery."

Douglass, who had escaped from slavery and taught himself to read, became a leading abolitionist in the North and an adviser to President Abraham Lincoln. "Mr. Douglass, perhaps more than any other man of his race, was instrumental in advancing the work of banishing the color line," the obituary said.

Mr. Booker said that Douglass had been a hero of his since childhood, when his parents taught him about great Americans. He described Douglass as "one who bent the arc of our history more toward justice," adding that he admired Douglass all the more for embracing manifold causes.

"He's a person who shows that all of our fights for justice are interwoven," Mr. Booker said

Mr. Booker said he strove to live up to Douglass's example.

"I'm hopeful that at the end of my life someone like Frederick Douglass would look at my life and say, 'Well done, you've proven yourself to be worthy of the legacy we left you,' " he said.

As a vegan, Mr. Booker acknowledged that choosing the dinner menu might be problematic. But he said he thought Douglass might enjoy the cuisine found at some of his favorite vegan restaurants in New Jersey.

"I would let him know that he could enjoy a healthy lifestyle, and really delicious food."

This summer, we invite you to join us as we exhume obituaries from our archives, some dating to the 19th century. You'll meet leaders, inventors, entertainers, artists, novelists and the infamous - each linked in some way to the obituary. On some days we'll ask influential people a simple question: If you could have dinner with one person who is no longer with us, who would it be, and why?

We welcome your feedback and ideas. You can send us an email using this form or tweet the editor of this project, Shreeya Sinha @shreeyasinha, or the main writer,@DSlotnik. Follow us on Twitter.

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Upton Sinclair, Whose Muckraking Changed the Meat Industry

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"The Jungle," a harrowing account of a Lithuanian immigrant's experience laboring in Chicago's meatpacking industry, was serialized in the Socialist magazine Appeal to Reason in 1905 before the installments were collected and published as a book in 1906.

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Description of Progressive Era's Health Reform Movement

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Describes the progressive era's historical dictionary

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VOLUNTARY NUTRITION LABELING

In response to the White House Conference, FDA developed a working draft of various approaches to nutrition labeling and asked for comment by nutritionists, consumer groups, and the food industry. Then in 1972 the agency proposed regulations that specified a format to provide nutrition information on packaged food labels. Inclusion of such information was to be voluntary, except when nutrition claims were made on the label, in labeling, or in advertising, or when nutrients were added to the food. In those cases, nutrition labeling would be mandatory. This action was based on Section 201(n) of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act) that stated that a food was misbranded if it "fails to reveal facts material in the light of such representation." FDA argued that when a manufacturer added a nutrient to a food or made claims about its nutrient content, nutrition labeling was necessary to present all of the material facts, both positive and negative, about that food (Hutt, 1995).

When finalized in 1973, these regulations specified that when nutrition labeling was present on labels of FDA-regulated foods, it was to include the number of calories; the grams of protein, carbohydrate, and fat; and the percent of the U.S. Recommended Daily Allowance (U.S. RDA) of protein, vitamins A and C, thiamin, riboflavin, niacin, calcium, and iron. Sodium, saturated fatty acids, and polyunsaturated fatty acids could also be included at the manufacturer's discretion. All were to be reported on the basis of an average or usual serving size. The U.S. RDAs were based on the Recommended Dietary Allowance (RDA) set forth by the National Academy of Sciences (NAS) in 1968 (NRC, 1968). Because of the need for a single set of standard nutrient requirements for nutrition labeling purposes, the values selected for the U.S. RDA were generally the highest value for each nutrient given in the RDA table for adult males and non-pregnant, non-lactating females. However, values for calcium and phosphorus were limited to 1 g because of their physical bulk and solubility. The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) provided for nutrition labeling of meat and poultry products in a similar manner through policy memoranda.

As can be seen in the annex to this chapter, few changes were made in nutrition labeling regulations over the next decade (Hutt, 1995; Scarbrough, 1995). FDA, USDA, and the Federal Trade Commission held hearings in 1978 to gather information on food labeling issues and suggestions on how to make improvements. The vast majority of comments from the hearing favored mandatory nutrition labeling but also suggested making changes to the format to make it more useful.

The Rise in Use of Undefined Nutrient Content and Health Claims on Labels

After 1973, scientific knowledge about the relationship between diet and health grew rapidly, and, as a result, consumers wanted to have more information on food labels, particularly on the labels of processed and packaged foods. Food manufacturers were eager to respond to the consumer interest and did so in a variety of ways, often through the use of an assortment of new, undefined claims on product labels that attempted to state or imply something about the special value of the food, such as "extremely low in saturated fat," in order to catch consumers' attention (Taylor and Wilkening, 2008a). The proliferation of ambiguous claims on labels and in advertising led to charges that the government was tolerating claims that were "at best confusing and at worst deceptive economically and potentially harmful" (IOM, 1990).

In addition to making claims about the nutritional content of foods, some food manufacturers were also interested in making label claims about the health benefits of their food products. FDA's regulations had prohibited the explicit discussion of disease or health on food labels since passage of the FD&C Act in 1938. The implementing regulations for that act stated that a food was deemed to be misbranded if its labeling "represents, suggests, or implies: That the food because of the presence or absence of certain dietary properties is adequate or effective in the prevention, cure, mitigation, or treatment of any disease or symptom." A food making such claims was considered to be misbranded or an illegal drug (Shank, 1989). This policy began when many of the links between diet and disease had yet to be established or substantiated. It helped prevent misleading and potentially harmful claims, but it also prevented useful and truthful claims from being made (Kessler, 1989). The agency's policy was challenged in 1984 when the Kellogg Company, in cooperation with the National Cancer Institute, began a labeling campaign using the back panel of a high-fiber breakfast cereal to link fiber consumption to a possible reduction in the risk of certain cancers. That campaign changed food labeling and marketing dramatically, as other companies, in the absence of regulatory action, began making similar claims (Geiger, 1998).

The Initiation of Rulemaking for Nutritional Claims

In August 1987, FDA published a proposed rule to change its policy by permitting health claims on food labeling if certain criteria were met. The proposal generated a large number of thoughtful and often conflicting comments and was followed by a series of meetings between the agency and the food industry, consumer groups, academia, and health professionals (Shank, 1989). A congressional hearing was also held in December 1987. Subsequently, in February 1990, FDA withdrew its original proposal and published a new proposal that defined appropriate health claims more narrowly and set new criteria to be met before allowing a claim. During this time FDA also was acting to increase the availability of nutrition information and to provide for more truthful nutritional claims on all foods. In an effort to respond to consumers and the food industry, FDA initiated rulemaking to provide more flexibility in making claims on foods that could be useful in reducing or maintaining body weight or calorie intake, to establish policies concerning the fortification of foods, to include sodium content in nutrition labeling and provide for claims about sodium and cholesterol content, and to allow for food labeling experiments, such as experiments on supermarket shelf labeling.

The surge in consumer interest in nutrition that was fueling the food industry's desire to highlight the positive nutritional attributes of food products was due, in part, to the publication in the late 1980s of two landmark consensus reports on nutrition and health. The Surgeon General's Report on Nutrition and Health (HHS, 1988) and the National Research Council's (NRC's) report Diet and Health: Implications for Reducing Chronic Disease Risk (NRC, 1989a) emphasized the relationship between diet and the leading causes of death among Americans (e.g., heart disease, cancers, strokes, and diabetes). They suggested that changes in current dietary patterns-in particular, reduced consumption of fat, saturated fatty acids, cholesterol, and sodium and increased amounts of complex carbohydrates and fiber-could lead to a reduced incidence of many chronic diseases. The Surgeon General's report also called on the food industry to reform products to reduce total fat and to carry nutrition labels on all foods. These reports made useful suggestions for planning healthy diets. However, without specific nutrition information on food labels, consumers were unable to determine how certain individual foods fit into dietary regimens that followed the recommendations of these reports. Major changes in nutrition labeling were necessary if food labels were to be useful to consumers interested in adhering to these recommendations.

INITIATIVES TO STANDARDIZE AND REQUIRE NUTRITION LABELING

In the summer of 1989, concerned that food labeling did not allow Americans to take advantage of the latest advances in nutrition, Dr. Louis W. Sullivan, then Secretary of the U.S. Department of Health and Human Services (HHS), directed FDA to undertake a comprehensive initiative to revise the food label (FDA, 1990). He later stated that, "As consumers shop for healthier food, they encounter confusion and frustration... . The grocery store has become a Tower of Babel and consumers need to be linguists, scientists and mind readers to understand the many labels they see" (HHS, 1990). This new food labeling initiative began with the publication of an advance notice of proposed rulemaking in August 1989 asking for public comment and a notice of public hearings to be held across the country to address the content and format of the nutrition label, ingredient labeling, and both nutrient content and health claims. Unlike the situation surrounding the follow-up to the 1978 public hearings when few regulatory changes were made, in 1989 a number of forces, such as advances in science, recommendations for dietary change, food industry use of the label, and the entry of state governments into the food labeling arena, coalesced to propel important changes in the regulatory framework for food labeling (Scarbrough, 1995).

Developing Reference Values

By July 1990, FDA had published proposed rules for the mandatory nutrition labeling of almost all packaged foods. FDA acknowledged that there was some question as to whether the agency had the legal authority under the FD&C Act to mandate nutrition labeling on all foods that were meaningful sources of calories or nutrients, so comments were requested on that issue as well as on the proposed nutrient requirements. Simultaneously, proposals were also published to replace the U.S. RDAs and to establish regulations for determining serving sizes to be used in nutrition labeling. In replacing the U.S. RDAs, FDA sought to base new values for vitamins and minerals, to be known as Reference Daily Intakes (RDIs), on the most recent RDAs (NRC, 1989b). In addition, FDA proposed to establish new values to be known as Daily Reference Values (DRVs) for food components considered important for good health (fat, saturated fatty acids, unsaturated fatty acids, cholesterol, carbohydrate, fiber, sodium, and potassium) for which RDAs had not been established by the NAS (also see page 71). While it was necessary to establish two separate categories of nutrients (RDIs and DRVs) for regulatory purposes, FDA proposed to group the nutrients into a single set of reference values known as "Daily Values" for use in presenting nutrition information on the food label.

Establishing Required Nutrients for Food Labels

In determining which nutrients and food components to require on the label, FDA looked to The Surgeon General's Report on Nutrition and Health (HHS, 1988) and the NRC's report Diet and Health: Implications for Reducing Chronic Disease Risk (NRC, 1989a). FDA proposed that calories and nutrients would be required to be listed on nutrition labels if (1) they were of public health significance as defined in these two documents, and (2) specific quantitative recommendations were set by NAS or other scientific organizations. Accordingly, FDA proposed the mandatory listing of calories, fat, saturated fat, cholesterol, sodium, carbohydrate, fiber, protein, vitamins A and C, calcium, and iron. Additional nutrients were required to be listed when added to a food or when claims were made about them.

FDA considered the addition of total sugars to the list of required food components to declare on the label; but total sugars did not meet the criterion of having specific quantitative recommendations for intake by a scientific organization. Accordingly, the inclusion of total sugars on the nutrition label was made voluntary unless a claim was made about the sugars content of the food. Some of the comments received suggested that nutrition labeling of added sugars content also be required, but FDA did not propose to do so. The agency based its decision on (1) the fact that there was no scientific evidence that the body makes any physiological distinction between added and naturally occurring sugars; (2) a concern that the declaration of added sugars only would under-represent the sugars content of foods high in naturally occurring sugars, thus misleading consumers who may need to be aware of total sugars; and (3) an expectation that with mandatory nutrition labeling, consumers could differentiate between sugar-containing foods with high versus low nutrient content and could therefore determine which foods had the highest nutrient density.

Moving Toward a Mandatory and Uniform Nutrition Labeling Policy

At the same time that FDA was developing its July 1990 proposal, a committee was formed at the Institute of Medicine (IOM), the health arm of NAS, to consider how food labels could be improved to help consumers adopt or adhere to healthy diets. FDA and FSIS/USDA sponsored the study based on the belief that changes in eating habits could improve the health of Americans and that food labeling could aid consumers in making wise dietary choices. The committee's report, Nutrition Labeling: Issues and Directions for the 1990s, was issued in September 1990 (IOM, 1990). It recommended that FDA and FSIS adopt regulations to institute mandatory and uniform nutrition labeling for almost all packaged foods, and it made recommendations concerning various facets of nutrition labeling, including the content and presentation of information, in order to support findings and recommendations of The Surgeon General's Report on Nutrition and Health (HHS, 1988) and the NRC's report Diet and Health: Implications for Reducing Chronic Disease Risk (NRC, 1989a). It also recommended that FDA and USDA should define descriptors (e.g., "high," "good source of") for the content of nutrients such as fat, cholesterol, sodium, and micronutrients.

PASSAGE OF THE NUTRITION LABELING AND EDUCATION ACT (NLEA) OF 1990

Congressional concerns about food labeling had been building for some time. Members of Congress were aware of consumer and industry interest in the subject and had responded by asking the General Accounting Office to investigate labeling issues and by introducing a variety of bills on the subject (Scarbrough, 1995). This culminated in November 1990 with passage of the NLEA, the most significant food labeling legislation in 50 years. The NLEA amended the Federal Food, Drug, and Cosmetic Act to give FDA explicit authority to require nutrition labeling on most food packages and specified the nutrients to be listed in the nutrition label. It also required that nutrients be presented in the context of the daily diet; specified that serving sizes should represent "an amount customarily consumed and which is expressed in a common household measure that is appropriate to the food"; and provided for a voluntary nutrition labeling program for raw fruits, vegetables, and fish. It also required standard definitions to be developed that characterized the level of nutrients and required that FDA provide for approved health claims. The NLEA's requirements for the content of the nutrition label were very similar to those in FDA's 1990 proposal except that the NLEA included complex carbohydrates and sugars in the list of required nutrients. It also permitted the agency to add or delete nutrients based on a determination that such a change would "assist consumers in maintaining healthy dietary practices." On November 27, 1991, FDA proposed 26 new food label regulations to implement the NLEA. These included a new proposal on nutrition labeling and the establishment of RDIs and DRVs and a proposal on serving sizes. General principles for nutrient content claims and the definition of terms for claims to be allowed were also proposed, as were general principles for health claims, followed by individual proposals pertaining to ten possible topic areas for health claims, such as dietary fiber and cancer, which were identified in the NLEA. While the format of the nutrition label was discussed in its November 27, 1991, proposal, FDA published a more detailed proposal for the format on July 20, 1992. The purpose of FDA's proposals was threefold: to clear up confusion that had surrounded nutrition labeling for years, to help consumers choose healthier diets, and to give food companies an incentive to improve the nutritional qualities of their products (Kessler, 1995).

The NLEA pertains only to those labels of food products regulated by FDA, which has label authority over the majority of foods. However, meat and poultry product labels are under the authority of FSIS in the USDA, and alcoholic beverage product labels are under the authority of the Alcohol and Tobacco Tax and Trade Bureau of the Department of the Treasury, formerly the Bureau of Alcohol, Tobacco and Firearms. Leadership at USDA strongly supported the claim that consumers need help to adopt and adhere to healthy diets. For this reason and to provide consistent regulation for all foods, the decision was made to have FSIS coordinate efforts with FDA to implement the requirements of NLEA for meat and poultry product labels (McCutcheon, 1995). To accomplish this, FSIS first published an advance notice of proposed rulemaking to solicit comments to assist in developing regulations for the nutrition labeling of meat and poultry products. Then, on November 27, 1991, in conjunction with FDA, FSIS published proposed rules to establish a voluntary nutrition labeling program for single-ingredient raw meat and poultry (consistent with NLEA's provision for raw fruits, vegetables, and fish) and mandatory nutrition labeling for all other meat and poultry products. It also proposed the adoption of most of FDA's proposals in regard to nutrient content claims and proposed additional definitions for "lean" and "extra lean" as unique descriptors for meat and poultry products.

The NLEA established very tight timeframes for implementing the provisions of the act. It required FDA to publish proposed regulations within 12 months and final regulations within 24 months of enactment of the act. If the agency failed to publish final regulations as specified, the proposed rules were to become final rules. With those time constraints and over 40,000 written comments on the proposed rules to respond to, FDA and FSIS mobilized their staffs to accomplish the task.

Declaration of Nutrient Content

Final regulations for both agencies were published on January 6, 1993, that mandated nutrition labeling in the form of a Nutrition Facts panel on most packaged foods. Exemptions were allowed for foods that were insignificant sources of calories or nutrients, foods shipped in bulk for further processing, restaurant foods, foods manufactured by some small businesses, medical foods, and infant formula (the latter having other specific rules for labeling). Nutrients to be listed on nutrition labels included calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamins A and C, calcium, and iron. By way of exception when present at insignificant amounts and when no claims were made about them, regulations allowed the declaration of calories from fat, saturated fat, cholesterol, dietary fiber, sugars, vitamins A and C, calcium or iron to be omitted if a footnote was added at the bottom of the list of nutrients stating "Not a significant source of ____" with the blank filled in by the name of the nutrients(s) omitted. If they chose to do so, manufacturers were permitted to list calories from saturated fat, polyunsaturated and monounsaturated fatty acids, potassium, soluble and insoluble fiber, sugar alcohols, other carbohydrates, and any vitamins and minerals for which RDIs were established; labeling became required, however, if vitamins and minerals were added to the product or if claims related to vitamin or mineral content were made. In order to reduce consumer confusion and avoid the potential for misleading labels, no other nutrients were allowed in the Nutrition Facts panel.

Despite being specified in the NLEA, complex carbohydrates were not included in the allowed list of nutrients. Comments had convinced FDA that there was no consensus on a definition for the term "complex carbohydrates" as it related to physiological effects, health benefits, or dietary guidance. Instead, the rules allowed for the voluntary listing of "other carbohydrates" to be calculated as that amount of carbohydrate remaining after subtraction of the amount of dietary fiber, sugars, and sugar alcohols from total carbohydrate.

Just as with the FDA proposals in 1990, the declaration of sugars also generated discussion in comments to the 1991 proposals to implement the NLEA. Based on comments received, the proposed definition of sugars as the sum of all free mono- and oligosaccharides through four saccharide units was changed to the sum of all free mono- and disaccharides. Other comments had recommended that added sugars should be listed rather than total sugars since there was both a dietary recommendation to use sugars in moderation and a dietary recommendation for increased consumption of fruits, which are sources of naturally occurring sugars (HHS/USDA, 1990). Opposing comments reiterated concerns expressed in the proposed rule that the body makes no physiological distinction between the two types of sugars and that under-representing total sugars content could be misleading to consumers concerned about total intake of sugars. The determinative issue, however, was that there were no analytical methods for distinguishing between the two types of sugars. Product labels are checked for accuracy and compliance by FDA through laboratory analysis of the food product as packaged. That analysis yields only a value for total sugars. FDA policy is that it should not promulgate regulations that it cannot enforce. Accordingly, the decision was made to list only total sugars in the Nutrition Facts panel.

Several comments on the 1991 proposed rule suggested that trans fatty acids ( trans fat) should be included in the nutrition label, either with saturated fat or as a separate category. FDA disagreed at the time because reports were inconsistent regarding the effects of trans unsaturated fats on blood cholesterol levels in humans (LSRO/FASEB, 1985; Grundy and Denke, 1990). However, soon afterwards, new data emerged indicating that trans fats raise LDL-cholesterol concentrations nearly as much as cholesterol-raising saturated fats (NIH, 1994). Based on its own independent evaluation of studies on the effects of trans fat on blood cholesterol levels, FDA concluded that under conditions of use in the United States, trans fats did contribute to increased serum LDL cholesterol, which increases the risk of coronary heart disease. As a result, a proposed rule was published in 1999 to modify the Nutrition Facts panel to include trans fats on food products regulated by FDA. In 2003, FDA issued a final rule requiring trans fats to be listed on a separate line immediately under saturated fat whenever present in amounts of 0.5 g or more per serving, except that it must always be listed if claims are made on the label about it. USDA regulations permit, but do not require, trans fat to be listed on nutrition labels of meat and poultry products provided the declaration and definitions of trans fat adhere to the FDA regulations.

Determination of Reference Values

As discussed above, for declaring amounts of vitamins and minerals, FDA had proposed replacing U.S. RDAs with RDIs based on the most current scientific knowledge as incorporated in the 1989 RDAs from the NAS (NRC, 1989b). It also proposed to use a population-adjusted mean of the RDA values for the various age-sex groups for each nutrient rather than the highest value for each nutrient. However, on October 6, 1992, Congress passed the Dietary Supplement Act of 1992 that, in section 203, instructed FDA not to promulgate for at least one year any regulations that required the use of, or were based upon, RDAs other than those in effect at that time. Inasmuch as the NLEA required that final rules be promulgated by November 6, 1992, FDA was unable to wait long enough to utilize the 1989 RDAs. Instead, FDA proceeded to change the name of the U.S. RDAs to RDIs to reduce confusion with the RDAs developed by the NAS while maintaining the values based on the NAS 1968 RDAs. Once the moratorium on using newer RDA values was over, FDA decided to wait until revisions then in progress at the NAS were finalized. It did, however, proceed to establish RDIs for those nutrients for which RDA values had not been established in 1968: vitamin K, selenium, manganese, chromium, molybdenum, and chloride. The agency also asked the NAS to convene a committee to provide scientific guidance about how to use the new Dietary Reference Intakes from the NAS to update the nutrient reference values used in the Nutrition Facts panel. The committee's report became available in 2003 (IOM, 2003). Then, in 2007, FDA issued an advance notice of proposed rulemaking asking for comment on which reference values the agency should use to calculate the percent of daily value in the Nutrition Facts panel and whether certain nutrients should be added or removed from the labels.

Establishment of Daily Reference Values

A challenge presented by the NLEA was the requirement that the nutritional information "be conveyed to the public in a manner which enables the public to readily observe and comprehend such information and to understand its relative significance in the context of a total daily diet." This requirement necessitated reporting in relation to a daily reference value the amounts of all nutrients listed and not just the amounts of vitamins and minerals, as had been done since voluntary nutrition labeling rules were put in place in 1973. In accordance with its 1990 proposal, the final nutrition labeling rules established for the first time reference values, known as Daily Reference Values (DRVs), that would be used in reporting values of total fat, saturated fatty acids, cholesterol, total carbohydrate, dietary fiber, sodium, and potassium-for which RDAs had not been established in 1989-and for protein. The DRVs were based largely on recommendations from The Surgeon General's Report on Nutrition and Health (HHS, 1988), the NRC's report Diet and Health: Implications for Reducing Chronic Disease Risk (NRC, 1989a), and the National Cholesterol Education Program's "Report of the Expert Panel on Population Strategies for Blood Cholesterol Reduction" (NIH, 1990). The recommendations used for total fat were 30 percent of calories or less; for saturated fat, less than 10 percent of calories; for cholesterol, less than 300 mg; for total carbohydrate, 60 percent of calories; for sodium, 2,400 mg; for potassium, 3,500 mg; and for protein, 10 percent of calories (so that calorie-providing nutrients sum to 100 percent of calories). The DRV for fiber, for which the two consensus documents had not provided a recommendation, was instead based on a recommendation in a report of the Life Sciences Research Organization of the Federation of American Societies for Experimental Biology that fiber intake be 10 to 13 g per 1,000 calories (LRSO, 1987). No recommendations existed for intake of sugars, so no DRV was established. For those nutrients for which the recommendation was for a percent of calories, the DRVs were based on a caloric intake of 2,000 calories. For example, the level for total fat was derived by calculating 30 percent of 2,000 calories and dividing by 9, which is the number of calories per gram of fat. The resulting value, 66.7 g, was then rounded down to 65 g for ease of use. In an effort to show consumers how the values would differ with different caloric intakes, the regulations called for a footnote on larger food packages that would state, "Your daily values may be higher or lower depending on your calorie needs," followed by a table showing the daily values for both a 2,000- and 2,500-calorie diet.

Basic Format of Nutrition Label

The format to be used for the nutrition label had been a topic of the 1989 advance notice of proposed rule-making and the public hearings on nutrition labeling. Many speakers at the public hearings supported a new label format in order to simplify the label and make it more understandable (FDA, 1990). Prior to the 1991 proposals, focus group sessions had been held (Lewis and Yetley, 1992) and experimental studies conducted (Levy et al., 1991, 1996) to determine the effectiveness of various label formats. The results were made available to the public, and comments were requested. FDA also initiated a cooperative pilot program with industry to test alternative formats which led to several industry-sponsored studies, and it held a public meeting on the subject. The research showed that graphic presentations, such as pie charts and bar graphs, were not well suited for conveying the diversity and amount of information required on nutrition labels, so FDA looked to a format based more on consumers' ability to use and comprehend numeric values (Scarbrough, 1995). The format proposed in July 1992 was one that included quantitative amounts of macronutrients but that gave particular emphasis to a column of nutrient values expressed as a percent of the label reference value, the RDIs and DRVs, which was to allow consumers to quickly determine if the food contained a little or a lot of a nutrient. At the end of the comment period, when a format had been determined that provided the proper context and emphasis, FDA worked with graphic experts to design the label, taking into account research on comprehension, legibility, and literacy (Kessler et al., 2003).

The format research and comments on the proposed rule had led FDA to conclude that in nutrition labeling a consistent system of percentages makes it possible for virtually all the nutrients on the label to be provided in equivalent units-as a percent of the appropriate RDI or DRV (to be known on the Nutrition Facts panel simply as the "Percent of Daily Value"). That consistency is not possible when the list contains nutrients given in different units (e.g., grams and milligrams). Thus, a low value on the list is likely to be a "true" low value within the context of the daily diet, and a high value is likely to be a "true" high value. This consistency also allowed educational programs to be built around the concept that 5 percent or less of any nutrient is a small amount, whereas 20 percent or more is a large amount (Taylor and Wilkening, 2008a). Consumers had often been confused by earlier nutrition label formats when comparing nutrient amounts, such as comparing fat in grams with sodium in milligrams, so the actual quantities were moved adjacent to the name of the nutrient where they would get less attention. To put emphasis on the amount of nutrients in a serving of food "in the context of a total daily diet," the format for the Nutrition Facts panel provided for a separate column for the listing of Percent of Daily Value (% Daily Value or %DV) (see Figure 2-1). Noticeably, a few nutrients are lacking a value in the %DV column. For trans fat and sugars, scientific evidence was not sufficient to support the establishment of a RDI or DRV. In the case of protein, a DRV had been established, but the %DV for protein required taking into account protein quality and not just the quantity of protein present. Such a calculation requires the computation of the protein-digestibility-corrected amino acid score for a food, a costly analysis. Because the typical American diet provides enough protein of sufficiently high biological quality to meet the nutritional needs of most persons, protein intake is not a public health concern. Therefore, listing the %DV for protein is voluntary for foods intended for adults and children 4 or more years of age unless a protein claim is made for the product.

Determination of Serving Size

The serving size of a food product affects virtually every number in the Nutrition Facts panel other than those in the footnote. As a result, the development of regulations prescribing the manner in which it is to be calculated for the wide diversity of foods available in the market was of major importance. The NLEA required that serving sizes be based on amounts customarily consumed rather than on recommended portion sizes, as some comments had suggested, or on a 100-g basis, as is done in some other countries. To determine the amount customarily consumed, FDA utilized food consumption data from USDA's nationwide food consumption and intake surveys, augmented by other sources of information where available. In order to facilitate consumer comparisons, categories of foods that are generally used interchangeably in the diet and that have similar product characteristics were developed so that those foods would have uniform serving sizes. Statistical analyses of consumption data, using the mean, median, and modal values, were then utilized to develop Reference Amounts Customarily Consumed (RACC) for each category. Procedures for converting the RACC values to serving sizes expressed in common household measures were specified in the regulations.

Single-Serving Containers

Single-serving-size containers proved to be particularly troublesome (Taylor and Wilkening, 2008a). The regulations require that most packages that are less than 200 percent of the applicable RACC must declare the entire package as one serving. If the package is 200 percent or more of the RACC and the whole unit can reasonably be consumed at one time, the manufacturer may, but need not, declare the package as one serving. For products that are more than 200 percent of the RACC yet intended to be consumed by one individual at one time, FDA has encouraged manufacturers to base the nutrition information on the entire contents of food in the container (CFSAN/FDA, 2004; FDA, 2004). Because there is little evidence that this is widely practiced (Taylor and Wilkening, 2008a), FDA asked in a 2005 advance notice of proposed rulemaking for comment on whether its regulations should be changed to require packages that can reasonably be consumed at one eating occasion to provide the nutrition information for the entire package, either alone or in conjunction with a listing of the serving size derived from the RACC. Also, because there is evidence that Americans are eating larger portion sizes than in the 1970s and 1980s, when the food consumption surveys upon which RACCS are based were conducted (Nielsen and Popkin, 2003; Smiciklas-Wright et al., 2003), comments were requested on which RACCs may need to be updated.

Serving Size and Health Outcomes

The increase in portion sizes consumed is considered to be one of many factors leading to increased obesity in the United States (Young and Nestle, 2002). To address the issue of obesity, Mark McClellan, then FDA Commissioner, created a committee in 2003 to outline an action plan to cover critical dimensions of the obesity problem from FDA's perspective and within its regulatory authorities. Among other topics, the committee's report, entitled Calories Count: Report of the Working Group on Obesity (FDA, 2004), addressed food labeling issues pertaining to serving sizes and the design of the Nutrition Facts panel. The advance notice of proposed rulemaking mentioned above was an outcome of that report, as was another advance notice asking for comment on ways to increase the prominence of calorie information on the label. At the time of this report, action on those issues is still awaited.

Specification of Nutrient Content Claims

In addition to requiring food labels to contain information on the amounts of certain nutrients, the NLEA also specified that claims characterizing the level of a nutrient may be made on food labels only if the characterization uses terms that have been defined in regulations. The NLEA further specified that claims characterizing the relationship of any nutrient to a disease or health-related condition be made only in accordance with regulations promulgated under the act; however, such claims, known as "health claims," are not the subject of this report and will not be discussed further here. The intent of this section of the NLEA was to allow meaningful comparisons of foods and to encourage the consumption of foods with the potential to improve dietary intake and reduce chronic disease (Taylor and Wilkening, 2008b).

Defining Descriptive Nutrient Content Claims

The act specifically required that definitions for the terms "free," "low," "light," "reduced," "less," and "high" in relation to nutrients required to be listed in the Nutrition Facts panel. In addition, to allow for the use of claims that were being used on labels of conventional foods in the marketplace, FDA and USDA also defined the terms "good source," "more," "fewer," "lean," and "extra lean" when implementing the NLEA and provided for the use of synonyms for many of the terms. Subsequently, both agencies also defined the implied claim "healthy." The current definitions for all these claims on FDA-regulated food items can be found in Appendix B of this report. A full discussion of the rationale behind the definition of each claim can be found in the preambles to the proposed (1991) and final (1993) rules (see Annex). It should be noted that the definitions for claims on individual food products differ in some respects from those for meal and main dish items. Meal and main dish items are combinations of foods intended to contribute a larger portion of the total daily diet, which necessitates separate criteria, often based on an amount per 100 g, in order to provide for appropriate claims.

Briefly, in developing the criteria for claims, FDA took into account the dietary recommendations for each nutrient; the amounts of the nutrient present per RACC, per serving size, and per 100 g; the distribution and abundance of the nutrient in the food supply; analytical methods; and the presence of other nutrients that could possibly cause a particular claim to be misleading.

Defining Levels of Nutrients to Limit

In the case of "free" claims, levels of each nutrient were selected that were at or near the reliable limit of detection for the nutrient in food and that were considered to be dietetically trivial or physiologically inconsequential. In the case of foods that are inherently free of a nutrient, regulations require that the claim must refer to all foods of that type rather than to a particular brand to which the labeling is attached (e.g., "broccoli, a fat-free food").

Claims for "low" levels of nutrients presented a bigger challenge and needed to be considered individually. The goal was "that the selection of a food bearing the term should assist consumers in assembling a prudent daily diet and in meeting overall dietary recommendations to limit the intake of certain nutrients." For nutrients that are ubiquitous in the food supply, the definition of a "low" level was set at 2 percent of the DRV for the nutrient. If the nutrient was not ubiquitous, the amount defined to be "low" was adjusted to account for the nutrient's uneven distribution in the food supply. In that way, if a person was to consume a reasonable number of servings of food labeled as "low," balanced with a number of servings of foods that do not contain the nutrient and a number of servings of foods that contain the nutrient at levels above the "low" level, he or she would still be able to stay within dietary recommendations. For example, the DRV for total fat was set at 65 g. Two percent of 65 g is 1.3 g, which was rounded up to 1.5 g. Since fat is not inherent in many foods (e.g., fruits, vegetables, non-dairy beverages, fat-free dairy products, jams, etc.), yet is found in more than a few foods, FDA concluded that an appropriate upper limit for a "low fat" claim should be set at two times 2 percent of the DRV, or 3 g. Balancing the number of foods that do not contain fat with those that contain more than "low" levels would allow a person consuming up to 20 foods a day to stay within the DRV of 65 g. An exception to this method of calculation was made for sodium inasmuch as the term "low sodium" had been defined 8 years earlier as 140 mg or less per serving (rather than 96 mg if following the new procedure) with no apparent concerns about that level. Also, unique to sodium, there was a regulatory definition for "very low sodium" at 35 mg or less per serving. Responding to comments, FDA maintained these definitions for use by individuals wishing to reduce total sodium intake and those on medically restricted diets.

Defining Levels of Nutrients to Encourage

Claims for "positive" nutrients (e.g., vitamins and minerals) are used to emphasize the presence of a nutrient. Regulations provide for claims at two levels, "high" and "good source." The definition for "high" was set at 20 percent or more of the appropriate RDI or DRV per serving. The IOM committee had suggested a criterion of greater than 20 percent for "high" claims (IOM, 1990), and in a review of its food consumption database FDA found that the 20 percent cut would permit a sufficient number of foods to make the claim. This in turn would enable consumers using the claim to select a diet from a wide variety of foods rather than from a few highly fortified foods. "Good source" claims, defined as 10 to 19 percent of the DRV, were intended to emphasize the presence of a nutrient at a mid-range of nutrient content, drawing consumers' attention to foods that contain a significant amount of a nutrient and that are likely to help meet dietary recommendations.

Implied Claims

As opposed to claims about the specific amount of a nutrient present in a food, "implied claims" are claims that describe a food or an ingredient in such a manner that the consumer is led to assume that a nutrient is absent or present in a certain amount (e.g., "high in wheat bran" implies that the food is high in fiber). Implied claims can also suggest that the food may be useful in maintaining healthy dietary practices. To that end, following publication of the final rules implementing NLEA, FDA and USDA issued proposed and final rules to define the implied claim implicit in "healthy." The term "healthy" was considered a unique nutrient content claim because it not only characterized the level of the nutrients in a food but also implied a judgment about the food. Comments on the proposed rule suggested that consumers had varying ideas of what the term meant, leading FDA to find that the "fundamental purpose of a 'healthy' claim is to highlight those foods that, based on their nutrient levels, are particularly useful in constructing a diet that conforms to current dietary guidelines." This led the FDA and USDA to set criteria that limited use of the term to foods that had "low" levels of fat and saturated fat and slightly more moderate levels of cholesterol and sodium (see Appendix B). In addition, the food (other than raw fruits or vegetables, a single ingredient or a mixture of canned or frozen fruits or vegetables or enriched cereal grain products that conform to a standard identity) had to contain at least 10 percent of the RDI or DRV of vitamin A, vitamin C, calcium, iron, protein, or fiber. As for sodium, FDA was persuaded that levels of it should be restricted so that foods bearing the "healthy" claim would be helpful in reaching dietary goals. Yet the agency found that the majority of products bearing the claim would be disqualified from doing so if sodium levels were set at a level as low as 360 mg per serving. Therefore, to provide time for the industry to reformulate their products and for consumers to become accustomed to lower levels of sodium, final regulations issued on May 10, 1994, provided a two-tier approach to sodium levels, specifying a maximum level for individual foods at 480 mg per serving, with a requirement that the level drop to 360 mg per serving by January 1, 1998. Prior to the 1998 date, FDA and USDA received petitions from a food manufacturer asking that the more restrictive second tier be eliminated or at least delayed until there were advances in food technology that allowed for the development of acceptable products with reduced sodium content. The agencies found that issues raised relative to technological and safety concerns of reduced-sodium foods merited further consideration, so it extended the effective date. This process continued until final rules were issued which abandoned the more restrictive sodium requirements altogether because of the documented technical difficulties in finding suitable alternatives for sodium that would be acceptable to consumers.

NUTRITION LABELING AS AN EVOLVING PROCESS

Nutrition labeling is a tool for consumers to use in selecting healthy diets that meet dietary recommendations. To accomplish this, it must be flexible enough to accommodate continuing advances in science and nutrition as well as changes in consumer behavior. The need for these changes is evidenced by the current advance notices of proposed rulemaking pertaining to modifications to give more prominence to calories, amendments to serving-size regulations, and the establishment of new reference values. Current activities regarding front-of-package labeling are another example of innovative approaches to nutrition labeling designed to help consumers select foods that may lead to more healthful diets.

REFERENCES

CFSAN/FDA (Center for Food Safety and Applied Nutrition/Food and Drug Administration). 2004. Letter to food manufacturers about accurate serving size declaration on food products. College Park, MD: FDA.

FDA. 2004. Calories count: Report of the working group on obesity. Washington, DC: Food and Drug Administration.

HHS (U.S. Department of Health and Human Services). 1988. The Surgeon General's Report on Nutrition and Health. . Washington, DC: U.S. Government Printing Office.

HHS. 1990. Remarks by Louis W. Sullivan, M.D., Secretary of Health and Human Services at the National Food Policy Conference (pp. 1-12). Washington, DC: HHS.

IOM (Institute of Medicine). 1990. Nutrition labeling, issues and directions for the 1990s . Washington, DC: National Academy Press. [ PubMed: 25144020 ]

IOM. 2003. Dietary Reference Intakes: Guiding principles for nutrition labeling and fortification . Washington, DC: The National Academies Press. [ PubMed: 24967483 ]

Kessler, D. A., J. R. Mande, F. E. Scarbrough, R. Schapiro, and K. Feiden. 2003. Developing the "Nutrition Facts" food label. Harvard Health Policy Review 4:13-24.

NIH. 1994. Expert panel on detection, evaluation, and treatment of high blood cholesterol in adults National Cholesterol Education Program: Second report of the expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel II) . Circulation 89:1329-1445.

NRC (National Research Council). 1968. Recommended Dietary Allowances. Washington, DC: National Research Council.

NRC. 1989. a. Diet and health: Implications for reducing chronic disease risk. Washington, DC: National Academy Press. [ PubMed: 25032333 ]

NRC. 1989. b. Recommended Dietary Allowances. 10th edition. Washington, DC: National Academy Press. [ PubMed: 25144070 ]

Taylor, C., and V. Wilkening. 2008. a. How the nutrition food label was developed, Part 1: The nutrition facts panel. Journal of the American Dietetic Association 108:437-442. [ PubMed: 18313424 ]

Taylor, C., and V. Wilkening. 2008. b. How the nutrition food label was developed, Part 2: The purpose and promise of nutrition claims. Journal of the American Dietetic Association 108:618-623. [ PubMed: 18375217 ]

WHC (White House Conference on Food, Nutrition, and Health) . 1970. White House conference on food, nutrition, and health: Final report. 1970. Washington, DC: U.S. Government Printing Office.

ANNEX MILESTONES IN NUTRITION LABELING

TABLE 2-1 Milestones in Nutrition Labeling

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In response to the White House Conference, FDA developed a working draft of various approaches to nutrition labeling and asked for comment by nutritionists, consumer groups, and the food industry. Then in 1972 the agency proposed regulations that specified a format to provide nutrition information on packaged food labels.

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International trade has changed our world drastically over the last couple of centuries. In this entry we begin by analyzing available data on historical trade patterns around the world, and then move on to discuss more recent data, outlining trade patterns from the last couple of decades.

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Food Safety: A Historical Look | Food Safety | Schuster Institute for Investigative Journalism | Brandeis University

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Our food safety laws are more than a century old. In 1999, the GAO warned that our "fragmented system was not developed under any rational plan. Learn more at the Schuster Institute for Investigative Journalism at Brandeis University.

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CONSTITUTIONAL RIGHTS FOUNDATION
Bill of Rights in Action

FALL 2008 (Volume 24, No. 1)
Reform
Communism, Capitalism, and Democracy in China | Upton Sinclair's The Jungle | John Dewey and the Reconstruction of American Democracy

Upton Sinclair wrote The Jungle to expose the appalling working conditions in the meat-packing industry. His description of diseased, rotten, and contaminated meat shocked the public and led to new federal food safety laws.

Before the turn of the 20th century, a major reform movement had emerged in the United States. Known as progressives, the reformers were reacting to problems caused by the rapid growth of factories and cities. Progressives at first concentrated on improving the lives of those living in slums and in getting rid of corruption in government.

By the beginning of the new century, progressives had started to attack huge corporations like Standard Oil, U.S. Steel, and the Armour meat-packing company for their unjust practices. The progressives revealed how these companies eliminated competition, set high prices, and treated workers as "wage slaves."

The progressives differed, however, on how best to control these big businesses. Some progressives wanted to break up the large corporations with anti-monopoly laws. Others thought state or federal government regulation would be more effective. A growing minority argued in favor of socialism, the public ownership of industries. The owners of the large industries dismissed all these proposals: They demanded that they be left alone to run their businesses as they saw fit.

Theodore Roosevelt was the president when the progressive reformers were gathering strength. Assuming the presidency in 1901 after the assassination of William McKinley, he remained in the White House until 1909. Roosevelt favored large-scale enterprises. "The corporation is here to stay," he declared. But he favored government regulation of them "with due regard of the public as a whole."

Roosevelt did not always approve of the progressive-minded journalists and other writers who exposed what they saw as corporate injustices. When David Phillips, a progressive journalist, wrote a series of articles that attacked U.S. senators of both political parties for serving the interests of big business rather than the people, President Roosevelt thought Phillips had gone too far. He referred to him as a man with a "muck-rake."

Even so, Roosevelt had to admit, "There is filth on the floor, and it must be scraped up with the muck-rake." The term "muckraker" caught on. It referred to investigative writers who uncovered the dark side of society.

Few places had more "filth on the floor" than the meat- packing houses of Chicago. Upton Sinclair, a largely unknown fiction writer, became an "accidental muckraker" when he wrote a novel about the meat-packing industry.

Packingtown

By the early 1900s, four major meat-packing corporations had bought out the many small slaughterhouse companies throughout the United States. Because they were so large, the Armour, Swift, Morris, and National Packing companies could dictate prices to cattle ranchers, feed growers, and consumers.

The Big Four meat-packing companies centralized their operations in a few cities. Largest of all was the meat-packing industry in Chicago. It spread through acres of stockyards, feed lots, slaughterhouses, and meat-processing plants. Together with the nearby housing area where the workers lived, this part of Chicago was known as Packingtown.

Long before Henry Ford adapted it to automobile production, meat packers had developed the first industrial assembly line. It was more accurately a "disassembly line," requiring nearly 80 separate jobs from the killing of an animal to processing its meat for sale. "Killing gangs" held jobs like "knockers," "rippers," "leg breakers," and "gutters." The animal carcasses moved continuously on hooks until processed into fresh, smoked, salted, pickled, and canned meats. The organs, bones, fat, and other scraps ended up as lard, soap, and fertilizer. The workers said that the meat-packing companies "used everything but the squeal."

Unskilled immigrant men did the backbreaking and often dangerous work, laboring in dark and unventilated rooms, hot in summer and unheated in winter. Many stood all day on floors covered with blood, meat scraps, and foul water, wielding sledgehammers and knives. Women and children over 14 worked at meat trimming, sausage making, and canning.

Most workers earned just pennies per hour and worked 10 hours per day, six days a week. A few skilled workers, however, made as much as 50 cents an hour as "pacesetters," who sped up the assembly line to maximize production. The use of pacesetters caused great discontent among the workers.

By 1904, most of Chicago's packing-house workers were recent immigrants from Poland, Slovakia, and Lithuania. They crowded into tenement apartments and rented rooms in Packingtown, next to the stinking stockyards and four city dumps.

Real estate agents sold some immigrants small houses on credit, knowing that few would be able to keep up with the payments due to job layoffs, pay cuts, or disabling injuries. When an immigrant fell behind in payments, the mortgage holder would foreclose, repaint, and sell the house to another immigrant family.

Upton Sinclair

Born in Baltimore in 1878, Upton Sinclair came from an old Virginia family. The Civil War had wiped out the family's wealth and land holdings. Sinclair's father became a traveling liquor salesman and alcoholic. The future author's mother wanted him to become a minister. At age 5, he wrote his first story. It told about a pig that ate a pin, which ended up in a family's sausage.

When he was 10, Sinclair's family moved to New York City where he went to school and college. While attending Columbia University, he began to sell stories to magazines. He specialized in western, adventure, sports, and war-hero fiction for working-class readers.

Sinclair graduated from Columbia in 1897, and three years later he married Meta Fuller. They had one child. Sinclair began to write novels but had difficulty getting them published.

As he was struggling to make a living as a writer, he began reading about socialism. He came to believe in the idea of a peaceful revolution in which Americans would vote for the government to take over the ownership of big businesses. He joined the Socialist Party in 1903, and a year later he began to write for Appeal to Reason, a socialist magazine.

In 1904, the meat-packer's union in Chicago went on strike, demanding better wages and working conditions. The Big Four companies broke the strike and the union by bringing in strikebreakers, replacements for those on strike. The new workers kept the assembly lines running while the strikers and their families fell into poverty.

The editor of Appeal to Reason suggested that Sinclair write a novel about the strike. Sinclair, at age 26, went to Chicago at the end of 1904 to research the strike and the conditions suffered by the meat-packing workers. He interviewed them, their families, lawyers, doctors, and social workers. He personally observed the appalling conditions inside the meat-packing plants.

The Jungle

The Jungle is Sinclair's fictionalized account of Chicago's Packingtown. The title reflects his view of the brutality he saw in the meat-packing business. The story centered on a young man, Jurgis Rudkis, who had recently immigrated to Chicago with a group of relatives and friends from Lithuania.

Full of hope for a better life, Jurgis married and bought a house on credit. He was elated when he got a job as a "shoveler of guts" at "Durham," a fictional firm based on Armour & Co., the leading Chicago meat packer.

Jurgis soon learned how the company sped up the assembly line to squeeze more work out of the men for the same pay. He discovered the company cheated workers by not paying them anything for working part of an hour.

Jurgis saw men in the pickling room with skin diseases. Men who used knives on the sped-up assembly lines frequently lost fingers. Men who hauled 100-pound hunks of meat crippled their backs. Workers with tuberculosis coughed constantly and spit blood on the floor. Right next to where the meat was processed, workers used primitive toilets with no soap and water to clean their hands. In some areas, no toilets existed, and workers had to urinate in a corner. Lunchrooms were rare, and workers ate where they worked.

Almost as an afterthought, Sinclair included a chapter on how diseased, rotten, and contaminated meat products were processed, doctored by chemicals, and mislabeled for sale to the public. He wrote that workers would process dead, injured, and diseased animals after regular hours when no meat inspectors were around. He explained how pork fat and beef scraps were canned and labeled as "potted chicken."

Sinclair wrote that meat for canning and sausage was piled on the floor before workers carried it off in carts holding sawdust, human spit and urine, rat dung, rat poison, and even dead rats. His most famous description of a meat-packing horror concerned men who fell into steaming lard vats:

. . . and when they were fished out, there was never enough of them left to be worth exhibiting,--sometimes they would be overlooked for days, till all but the bones of them had gone out to the world as Durham's Pure Leaf Lard!

Jurgis suffered a series of heart-wrenching misfortunes that began when he was injured on the assembly line. No workers' compensation existed, and the employer was not responsible for people injured on the job. Jurgis' life fell apart, and he lost his wife, son, house, and job.

Then Jurgis met a socialist hotel owner, who hired him as a porter. Jurgis listened to socialist speakers who appeared at the hotel, attended political rallies, and drew inspiration from socialism. Sinclair used the speeches to express his own views about workers voting for socialist candidates to take over the government and end the evils of capitalist greed and "wage slavery."

In the last scene of the novel, Jurgis attended a celebration of socialist election victories in Packingtown. Jurgis was excited and once again hopeful. A speaker, probably modeled after Socialist Party presidential candidate Eugene V. Debs, begged the crowd to "Organize! Organize! Organize!" Do this, the speaker shouted, and "Chicago will be ours! Chicago will be ours! CHICAGO WILL BE OURS!"

The Public Reaction

The Jungle was first published in 1905 as a serial in The Appeal to Reason and then as a book in 1906. Sales rocketed. It was an international best-seller, published in 17 languages.

Sinclair was dismayed, however, when the public reacted with outrage about the filthy and falsely labeled meat but ignored the plight of the workers. Meat sales dropped sharply. "I aimed at the public's heart," he said, "and by accident I hit it in the stomach."

Sinclair thought of himself as a novelist, not as a muckraker who investigated and wrote about economic and social injustices. But The Jungle took on a life of its own as one of the great muckraking works of the Progressive Era. Sinclair became an "accidental muckraker."

The White House was bombarded with mail, calling for reform of the meat-packing industry. After reading The Jungle, President Roosevelt invited Sinclair to the White House to discuss it. The president then appointed a special commission to investigate Chicago's slaughterhouses.

The special commission issued its report in May 1906. The report confirmed almost all the horrors that Sinclair had written about. One day, the commissioners witnessed a slaughtered hog that fell part way into a worker toilet. Workers took the carcass out without cleaning it and put it on a hook with the others on the assembly line.

The commissioners criticized existing meat-inspection laws that required only confirming the healthfulness of animals at the time of slaughter. The commissioners recommended that inspections take place at every stage of the processing of meat. They also called for the secretary of agriculture to make rules requiring the "cleanliness and wholesomeness of animal products."

New Federal Food Laws

President Roosevelt called the conditions revealed in the special commission's report "revolting." In a letter to Congress, he declared, "A law is needed which will enable the inspectors of the [Federal] Government to inspect and supervise from the hoof to the can the preparation of the meat food product."

Roosevelt overcame meat-packer opposition and pushed through the Meat Inspection Act of 1906. The law authorized inspectors from the U.S. Department of Agriculture to stop any bad or mislabeled meat from entering interstate and foreign commerce. This law greatly expanded federal government regulation of private enterprise. The meat packers, however, won a provision in the law requiring federal government rather than the companies to pay for the inspection.

Sinclair did not like the law's regulation approach. True to his socialist convictions, he preferred meat-packing plants to be publicly owned and operated by cities, as was commonly the case in Europe.

Passage of the Meat Inspection Act opened the way for Congress to approve a long-blocked law to regulate the sale of most other foods and drugs. For over 20 years, Harvey W. Wiley, chief chemist at the Department of Agriculture, had led a "pure food crusade." He and his "Poison Squad" had tested chemicals added to preserve foods and found many were dangerous to human health. The uproar over The Jungle revived Wiley's lobbying efforts in Congress for federal food and drug regulation.

Roosevelt signed a law regulating foods and drugs on June 30, 1906, the same day he signed the Meat Inspection Act. The Pure Food and Drug Act regulated food additives and prohibited misleading labeling of food and drugs. This law led to the formation of the federal Food and Drug Administration (FDA).

The two 1906 laws ended up increasing consumer confidence in the food and drugs they purchased, which benefitted these businesses. The laws also acted as a wedge to expand federal regulation of other industries, one of the strategies to control big business pursued by the progressives.

After The Jungle

The Jungle made Upton Sinclair rich and famous. He started a socialist colony in a 50-room mansion in New Jersey, but the building burned down after a year. In 1911, his wife ran off with a poet. He divorced her, but soon he remarried and moved to California.

During his long life, he wrote more than 90 novels. King Coal was based on the 1914 massacre of striking miners and their families in Colorado. Boston was about the highly publicized case of Sacco and Vancetti, two anarchists tried and executed for bank robbery and murder in the 1920s. His novel Dragon's Teeth, about Nazi Germany, won the 1943 Pulitzer Prize. None of these novels, however, achieved the success of The Jungle.

Several of Sinclair's books were made into movies. In 1914, Hollywood released a movie version of The Jungle. Recently, his work Oil!, which dealt with California's oil industry in the 1920s, was made into the film There Will Be Blood.

During the Great Depression, Sinclair entered electoral politics. He ran for governor of California as a socialist in 1930 and as a Democrat in 1934. In the 1934 election, he promoted a program he called "End Poverty in California." He wanted the state to buy idle factories and abandoned farms and lease them to the unemployed. The Republican incumbent governor, Frank Merriam, defeated him, but Sinclair still won over 800,000 votes (44 percent).

After the death of his second wife in 1961, Sinclair moved to New Jersey to be with his son. He died there in 1968 at age 90.

People still read The Jungle for its realistic picture of conditions in the meat-packing industry at the turn of the 20th century. Like Harriet Beecher Stowe's Uncle Tom's Cabin, The Jungle proved the power of fiction to move a nation.

For Discussion and Writing

1. Why did the existing inspection system fail to guard the safety of meat for human consumption?

2. Why was Upton Sinclair dismayed about the public reaction and legislation that followed publication of The Jungle?

3. How did The Jungle help the progressives achieve their goals?

For Further Reading

Mattson, Kevin. Upton Sinclair and the Other American Century. Hoboken, N. J.: John Wiley & Sons, 2006.

Phelps, Christopher, ed. The Jungle by Upton Sinclair. Boston: Bedford/St. Martin's, 2005.

A C T I V T Y

Working in Packingtown

Upton Sinclair was disappointed that Congress did not address the injustices suffered by workers in Packingtown's meat-packing industry. Take on the role of a muckraker and write an editorial that details the injustices to workers and what Congress should do about them.

A L T E R N A T I V E A C T I V I T Y

A Modern Muckraker

Look at a contemporary problem in the community, state, or nation. Investigate it. Write an editorial on what should be done about it.

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BRIA 24 1 b Upton Sinclairs The Jungle: Muckraking the Meat-Packing Industry - Constitutional Rights Foundation

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Reform Communism, Capitalism, and Democracy in China | Upton Sinclair's The Jungle | John Dewey and the Reconstruction of American Democracy Upton Sinclair wrote The Jungle to expose the appalling working conditions in the meat-packing industry. His description of diseased, rotten, and contaminated meat shocked the public and led to new federal food safety laws.

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From the beginnings of civilization people have been concerned about the quality and safety of foods and medicines. In 1202, King John of England proclaimed the first English food law, the Assize of Bread, which prohibited adulteration of bread with such ingredients as ground peas or beans. Regulation of food in the United States dates from early colonial times. Federal controls over the drug supply began with inspection of imported drugs in 1848, although the first federal biologics law, which addressed the provision of reliable smallpox vaccine to citizens, was passed in 1813. The following chronology describes some of the milestones in the history of food and drug regulation in the United States.
1820
Eleven physicians meet in Washington, D.C., to establish the U.S. Pharmacopeia, the first compendium of standard drugs for the United States.
1848
Drug Importation Act passed by Congress requires U.S. Customs Service inspection to stop entry of adulterated drugs from overseas.
1862
President Lincoln appoints a chemist, Charles M. Wetherill, to serve in the new Department of Agriculture. This was the beginning of the Bureau of Chemistry, the predecessor of the Food and Drug Administration.
1880
Peter Collier, chief chemist, U.S. Department of Agriculture, recommends passage of a national food and drug law, following his own food adulteration investigations. The bill was defeated, but during the next 25 years more than 100 food and drug bills were introduced in Congress.

Dr. Harvey W. Wiley becomes chief chemist, expanding the Bureau of Chemistry's food adulteration studies. Campaigning for a federal law, Dr. Wiley is called the "Crusading Chemist" and "Father of the Pure Food and Drugs Act." He retired from government service in 1912 and died in 1930.
1897
Tea Importation Act passed, providing for Customs inspection of all tea entering U.S. ports, at the expense of the importers.
1898
Association of Official Agricultural Chemists (now AOAC International) establishes a Committee on Food Standards headed by Dr. Wiley. States begin incorporating these standards into their food statutes.
1902
The Biologics Control Act is passed to ensure purity and safety of serums, vaccines, and similar products used to prevent or treat diseases in humans.

Congress appropriates $5,000 to the Bureau of Chemistry to study chemical preservatives and colors and their effects on digestion and health. Dr. Wiley's studies draw widespread attention to the problem of food adulteration. Public support for passage of a federal food and drug law grows.
1906
The original Food and Drugs Act is passed by Congress on June 30 and signed by President Theodore Roosevelt. It prohibits interstate commerce in misbranded and adulterated foods, drinks and drugs.

The Meat Inspection Act is passed the same day.

Shocking disclosures of insanitary conditions in meat-packing plants, the use of poisonous preservatives and dyes in foods, and cure-all claims for worthless and dangerous patent medicines were the major problems leading to the enactment of these laws.
1907
First Certified Color Regulations, requested by manufacturers and users, list seven colors found suitable for use in foods.
1911
In U.S. v. Johnson, the Supreme Court rules that the 1906 Food and Drugs Act does not prohibit false therapeutic claims but only false and misleading statements about the ingredients or identity of a drug.

1912

Congress enacts the Sherley Amendment to over come the ruling in U.S. v. Johnson. It prohibits labeling medicines with false therapeutic claims intended to defraud the purchaser, a standard difficult to prove.

Mrs. Winslow's Soothing Syrup for teething and colicky babies, unlabeled yet laced with morphine, killed many infants.
1913
Gould Amendment requires that food package contents be "plainly and conspicuously marked on the outside of the package in terms of weight, measure, or numerical count."
1914
In U.S. v. Lexington Mill and Elevator Company, the Supreme Court issues its first ruling on food additives. It ruled that in order for bleached flour with nitrite residues to be banned from foods, the government must show a relationship between the chemical additive and the harm it allegedly caused in humans. The court also noted that the mere presence of such an ingredient was not sufficient to render the food illegal.

The Harrison Narcotic Act requires prescriptions for products exceeding the allowable limit of narcotics and mandates increased record-keeping for physicians and pharmacists who dispense narcotics.
1924
In U.S. v. 95 Barrels Alleged Apple Cider Vinegar, the Supreme Court rules that the Food and Drugs Act condemns every statement, design, or device on a product's label that may mislead or deceive, even if technically true.
1927
The Bureau of Chemistry is reorganized into two separate entities. Regulatory functions are located in the Food, Drug, and Insecticide Administration, and nonregulatory research is located in the Bureau of Chemistry and Soils.
1930
McNary-Mapes Amendment authorizes FDA standards of quality and fill-of-container for canned food, excluding meat and milk products.

The name of the Food, Drug, and Insecticide Administration is shortened to Food and Drug Administration (FDA) under an agricultural appropriations act.
1933
FDA recommends a complete revision of the obsolete 1906 Food and Drugs Act. The first bill is introduced into the Senate, launching a five-year legislative battle. 1935

U.S. Government begins publication of the Federal Register.

1937, containing the poisonous solvent diethylene glycol, kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.

Elixir of Sulfanilamide
1938
The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 is passed by Congress, containing new provisions:

Extending control to cosmetics and therapeutic devices.

Requiring new drugs to be shown safe before marketing-starting a new system of drug regulation.

Eliminating the Sherley Amendment requirement to prove intent to defraud in drug misbranding cases.

Providing that safe tolerances be set for unavoidable poisonous substances.

Authorizing standards of identity, quality, and fill-of-container for foods.

Authorizing factory inspections.

Adding the remedy of court injunctions to the previous penalties of seizures and prosecutions.

Under the Wheeler-Lea Act, the Federal Trade Commission is charged with overseeing advertising associated with products otherwise regulated by FDA.
1939
First Food Standards issued (canned tomatoes, tomato purée, and tomato paste).
1940
FDA transferred from the Department of Agriculture to the Federal Security Agency, with Walter G. Campbell appointed as the first Commissioner of Food and Drugs.
1941
Insulin Amendment requires FDA to test and certify purity and potency of this lifesaving drug for diabetes
1943
In U.S. v. Dotterweich, the Supreme Court rules that the responsible officials of a corporation, as well as the corporation itself, may be prosecuted for violations. It need not be proven that the officials intended, or even knew of, the violations.
1944
Public Health Service Act is passed, covering a broad spectrum of health concerns, including regulation of biological products and control of communicable diseases.
1945
Penicillin Amendment requires FDA testing and certification of safety and effectiveness of all penicillin products. Later amendments extended this requirement to all antibiotics. In 1983 such control was found no longer needed and was abolished.
1948
Miller Amendment affirms that the Federal Food, Drug, and Cosmetic Act applies to goods regulated by the Agency that have been transported from one state to another and have reached the consumer.
1949
FDA publishes guidance to industry for the first time. This guidance, "Procedures for the Appraisal of the Toxicity of Chemicals in Food," came to be known as the "black book."
1950
In Alberty Food Products Co. v. U.S. , a court of appeals rules that the directions for use on a drug label must include the purpose for which the drug is offered. Therefore, a worthless remedy cannot escape the law by not stating the condition it is supposed to treat.

Oleomargarine Act requires prominent labeling of colored oleomargarine, to distinguish it from butter.

Delaney Committee starts congressional investigation of the safety of chemicals in foods and cosmetics, laying the foundation for the 1954 Miller Pesticide Amendment, the 1958 Food Additives Amendment, and the 1960 Color Additive Amendment.
1951
Durham-Humphrey Amendment defines the kinds of drugs that cannot be safely used without medical supervision and restricts their sale to prescription by a licensed practitioner.
1952
In U.S. v. Cardiff, the Supreme Court rules that the factory inspection provision of the 1938 FDC Act is too vague to be enforced as criminal law.

FDA consumer consultants are appointed in each field district to maintain communications with consumers and ensure that FDA considers their needs and problems.
1953
Federal Security Agency becomes the Department of Health, Education, and Welfare (HEW).

Factory Inspection Amendment clarifies previous law and requires FDA to give manufacturers written reports of conditions observed during inspections and analyses of factory samples.
1954
Miller Pesticide Amendment spells out procedures for setting safety limits for pesticide residues on raw agricultural commodities.

First large-scale radiological examination of food carried out by FDA when it received reports that tuna suspected of being radioactive was being imported from Japan following atomic blasts in the Pacific. FDA begins monitoring around the clock to meet the emergency.
1955
HEW Secretary Oveta Culp Hobby appoints a committee of 14 citizens to study the adequacy of FDA's facilities and programs. The committee recommends a substantial expansion of FDA staff and facilities, a new headquarters building, and more use of educational and informational programs.

The Division of Biologics Control became an independent entity within the National Institutes of Health, after polio vaccine thought to have been inactivated is associated with about 260 cases of polio.
1958
Food Additives Amendment enacted, requiring manufacturers of new food additives to establish safety. The Delaney proviso prohibits the approval of any food additive shown to induce cancer in humans or animals.

FDA publishes in the Federal Register the first list of substances generally recognized as safe (GRAS). The list contains nearly 200 substances.
1959
U.S. cranberry crop recalled three weeks before Thanksgiving for FDA tests to check for aminotriazole, a weedkiller found to cause cancer in laboratory animals. Cleared berries were allowed a label stating that they had been tested and had passed FDA inspection, the only such endorsement ever allowed by FDA on a food product.
1960
Color Additive Amendment enacted, requiring manufacturers to establish the safety of color additives in foods, drugs and cosmetics. The Delaney proviso prohibits the approval of any color additive shown to induce cancer in humans or animals.

Federal Hazardous Substances Labeling Act, enforced by FDA, requires prominent label warnings on hazardous household chemical products.
1962
Thalidomide, a new sleeping pill, is found to have caused birth defects in thousands of babies born in western Europe. News reports on the role of Dr. Frances Kelsey, FDA medical officer, in keeping the drug off the U.S. market, arouse public support for stronger drug regulation.

Kefauver-Harris Drug Amendments passed to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them. The new law also exempts from the Delaney proviso animal drugs and animal feed additives shown to induce cancer but which leave no detectable levels of residue in the human food supply.

Consumer Bill of Rights is proclaimed by President John F. Kennedy in a message to Congress. Included are the right to safety, the right to be informed, the right to choose, and the right to be heard.
1965
Drug Abuse Control Amendments are enacted to deal with problems caused by abuse of depressants, stimulants and hallucinogens.
1966
FDA contracts with the National Academy of Sciences/National Research Council to evaluate the effectiveness of 4,000 drugs approved on the basis of safety alone between 1938 and 1962.

Child Protection Act enlarges the scope of the Federal Hazardous Substances Labeling Act to ban hazardous toys and other articles so hazardous that adequate label warnings could not be written.

Fair Packaging and Labeling Act requires all consumer products in interstate commerce to be honestly and informatively labeled, with FDA enforcing provisions on foods, drugs, cosmetics, and medical devices.
1968
FDA Bureau of Drug Abuse Control and Treasury Department Bureau of Narcotics are transferred to the Department of Justice to form the Bureau of Narcotics and Dangerous Drugs (BNDD), consolidating efforts to police traffic in abused drugs.

Reorganization of federal health programs places FDA in the Public Health Service.

FDA forms the Drug Efficacy Study Implementation (DESI) to implement recommendations of the National Academy of Sciences investigation of effectiveness of drugs first marketed between 1938 and 1962.

Animal Drug Amendments place all regulation of new animal drugs under one section of the Food, Drug, and Cosmetic Act-Section 512-making approval of animal drugs and medicated feeds more efficient.
1969
FDA begins administering Sanitation Programs for milk, shellfish, food service, and interstate travel facilities, and for preventing poisoning and accidents. These responsibilities were transferred from other units of the Public Health Service.

The White House Conference on Food, Nutrition, and Health recommends systematic review of GRAS substances in light of FDA's ban of the artificial sweetener cyclamate. President Nixon orders FDA to review its GRAS list.
1970
In Upjohn v. Finch the Court of Appeals upholds enforcement of the 1962 drug effectiveness amendments by ruling that commercial success alone does not constitute substantial evidence of drug safety and efficacy.

FDA requires the first patient package insert: oral contraceptives must contain information for the patient about specific risks and benefits.

Drug Abuse Prevention and Control Act replaces previous laws and categorizes drugs based on abuse and addiction potential compared to their therapeutic value.

Environmental Protection Agency established; takes over FDA program for setting pesticide tolerances.
1971
PHS Bureau of Radiological Health transferred to FDA. Its mission: protection against unnecessary human exposure to radiation from electronic products in the home, industry, and the healing arts.

National Center for Toxicological Research is established in the biological facilities of the Pine Bluff Arsenal in Arkansas. Its mission is to examine biological effects of chemicals in the environment, extrapolating data from experimental animals to human health.

Artificial sweetener saccharin, included in FDA's original GRAS list, is removed from the list pending new scientific study.
1972
Over-the-Counter Drug Review begun to enhance the safety, effectiveness and appropriate labeling of drugs sold without prescription.

Regulation of Biologics--including serums, vaccines, and blood products--is transferred from NIH to FDA.
1973
The U.S. Supreme Court upholds the 1962 drug effectiveness law and endorses FDA action to control entire classes of products by regulations rather than to rely only on time-consuming litigation.

Low-acid food processing regulations issued, after botulism outbreaks from canned foods, to ensure that low-acid packaged foods have adequate heat treatment and are not hazardous.

Consumer Product Safety Commission created by Congress; takes over programs pioneered by FDA under 1927 Caustic Poison Act, 1960 Federal Hazardous Substances Labeling Act, 1966 Child Protection Act, and PHS accident prevention activities for safety of toys, home appliances, etc.
1976
Medical Device Amendments passed to ensure safety and effectiveness of medical devices, including diagnostic products. The amendments require manufacturers to register with FDA and follow quality control procedures. Some products must have pre-market approval by FDA; others must meet performance standards before marketing.

Vitamins and Minerals Amendments ("Proxmire Amendments") stop FDA from establishing standards limiting potency of vitamins and minerals in food supplements or regulating them as drugs based solely on potency.
1977
Saccharin Study and Labeling Act passed by Congress to stop FDA from banning the chemical sweetener but requiring a label warning that it has been found to cause cancer in laboratory animals.
1979
Introduction of the Bioresearch Monitoring Program as an agency-wide initiative ensures the quality and integrity of data submitted to FDA and provides for the protection of human subjects in clinical trials by focusing on preclinical studies on animals, clinical investigations, and the work of institutional review boards.

In the hours following the Three Mile Island nuclear emergency of March 28, 1979, FDA contracted with firms in Missouri, Michigan, and New Jersey to prepare and package enough doses of potassium iodide to protect those threatened with thyroid cancer if exposed to radiation. Nearly one quarter of a million bottles-enough for every household in the area-were delivered to Harrisburg, Pennsylvania within 72 hours.
1980
Infant Formula Act establishes special FDA controls to ensure necessary nutritional content and safety
1981
FDA and the Department of Health and Human Services revise regulations for human subject protections, based on the 1979 Belmont Report, which had been issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The revised rules provide for wider representation on institutional review boards and they detail elements of what constitutes informed consent, among other provisions.
1982
Tamper-resistant Packing Regulations issued by FDA to prevent poisonings such as deaths from cyanide placed in Tylenol capsules. The Federal Anti-Tampering Act passed in 1983 makes it a crime to tamper with packaged consumer products.

FDA publishes first Red Book (successor to 1949 "black book"), officially known as Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food.
1983
Orphan Drug Act passed, enabling FDA to promote research and marketing of drugs needed for treating rare diseases.
1984
Fines Enhancement Laws of 1984 and 1987 amend the U.S. Code to greatly increase penalties for all federal offenses. The maximum fine for individuals is now $100,000 for each offense and $250,000 if the violation is a felony or causes death. For corporations, the amounts are doubled.

Drug Price Competition and Patent Term Restoration Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without repeating the research done to prove them safe and effective. At the same time, the brand-name companies can apply for up to five years additional patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process.
1985
AIDS test for blood approved by FDA in its first major action to protect patients from infected donors.
1986
Childhood Vaccine Act requires patient information on vaccines, gives FDA authority to recall biologics, and authorizes civil penalties.
1987
Investigational drug regulations revised to expand access to experimental drugs for patients with serious diseases with no alternative therapies.
1988
Food and Drug Administration Act of 1988 officially establishes FDA as an agency of the Department of Health and Human Services with a Commissioner of Food and Drugs appointed by the President with the advice and consent of the Senate, and broadly spells out the responsibilities of the Secretary and the Commissioner for research, enforcement, education, and information.

The Prescription Drug Marketing Act bans the diversion of prescription drugs from legitimate commercial channels. Congress finds that the resale of such drugs leads to the distribution of mislabeled, adulterated, subpotent, and counterfeit drugs to the public. The new law requires drug wholesalers to be licensed by the states; restricts reimportation from other countries; and bans sale, trade or purchase of drug samples, and traffic or counterfeiting of redeemable drug coupons.

Generic Animal Drug and Patent Term Restoration Act extends to veterinary products benefits given to human drugs under the 1984 Drug Price Competition and Patent Term Restoration Act. Companies can produce and sell generic versions of animal drugs approved after October 1962 without duplicating research done to prove them safe and effective. The act also authorizes extension of animal drug patents.
1989
FDA issues a nationwide recall of all over-the-counter dietary supplements containing 100 milligrams or more of L-Tryptophan, due to a clear link between the consumption of L-tryptophan tablets and its association with a U.S. outbreak of Eosinophilia Myalgia Syndrome (EMS), characterized by fatigue, shortness of breath, and other symptoms. By 1990 the Centers for Disease Control and Prevention confirm over 1,500 cases of EMS, including 38 deaths, and FDA prohibits the importation of l-tryptophan.
1990
Responding to increasing illicit traffic, Congress passes the Anabolic Steroid Act of 1990, which identifies anabolic steroids as a class of drugs and specifies over two dozen items as controlled substances. In addition, a four-part definition of this class is established to permit new, black market compounds to be assigned to this category, and thus subject to regulation as controlled substances.

Nutrition Labeling and Education Act requires all packaged foods to bear nutrition labeling and all health claims for foods to be consistent with terms defined by the Secretary of Health and Human Services. The law preempts state requirements about food standards, nutrition labeling, and health claims and, for the first time, authorizes some health claims for foods. The food ingredient panel, serving sizes, and terms such as "low fat" and "light" are standardized.

Safe Medical Devices Act is passed, requiring nursing homes, hospitals, and other facilities that use medical devices to report to FDA incidents that suggest that a medical device probably caused or contributed to the death, serious illness, or serious injury of a patient. Manufacturers are required to conduct post-market surveillance on permanently implanted devices whose failure might cause serious harm or death, and to establish methods for tracing and locating patients depending on such devices. The act authorizes FDA to order device product recalls and other actions.
1991
Regulations published to Accelerate the Review of Drugs for life-threatening diseases.

The policy for protection of human subjects in research, promulgated in 1981 by FDA and the Department of Health and Human Services, is adopted by more than a dozen federal entities involved in human subject research and becomes known as the Common Rule. This rule issues requirements for researchers who obtain and document informed consent, secures special protection for children, women, and prisoners, elaborates on required procedures for institutional review boards, and ensures that research institutions comply with the regulations.
1992
Generic Drug Enforcement Act imposes debarment and other penalties for illegal acts involving abbreviated drug applications.

Prescription Drug User Fee Act requires drug and biologics manufacturers to pay fees for product applications and supplements, and other services. The act also requires FDA to use these funds to hire more reviewers to assess applications.

Mammography Quality Standards Act requires all mammography facilities in the United States to be accredited and federally certified as meeting quality standards effective Oct. 1, 1994. After initial certification, facilities must pass annual inspections by federal or state inspectors.

Nutrition facts, basic per-serving nutritional information, are required on foods under the Nutrition Labeling and Education Act of 1990. Based on the latest public health recommendations, FDA and the Food Safety and Inspection Service of the Department of Agriculture recreate the food label to list the most important nutrients in an easy-to-follow format.
1993
A consolidation of several adverse reaction reporting systems is launched as MedWatch, designed for voluntary reporting of problems associated with medical products to be filed with FDA by health professionals.

Revising a policy from 1977 that excluded women of childbearing potential from early drug studies, FDA issues guidelines calling for improved assessments of medication responses as a function of gender. Companies are encouraged to include patients of both sexes in their investigations of drugs and to analyze any gender-specific phenomena.
1994
Dietary Supplement Health and Education Act establishes specific labeling requirements, provides a regulatory framework, and authorizes FDA to promulgate good manufacturing practice regulations for dietary supplements. This act defines "dietary supplements" and "dietary ingredients" and classifies them as food. The act also establishes a commission to recommend how to regulate claims.

FDA announces it could consider regulating nicotine in cigarettes as a drug, in response to a Citizen's Petition by the Coalition on Smoking OR Health.

Uruguay Round Agreements Act extends the patent terms of U.S. drugs from 17 to 20 years.

Animal Medicinal Drug Use Clarification Act allows veterinarians to prescribe extra-label use of veterinary drugs for animals under specific circumstances. In addition, the legislation allows licensed veterinarians to prescribe human drugs for use in animals under certain conditions.
1995
FDA declares cigarettes to be "drug delivery devices." Restrictions are proposed on marketing and sales to reduce smoking by young people.

A series of proposed reforms to reduce regulatory burden on pharmaceutical manufacturers is announced, including an expansion of allowable promotional material on approved uses of drugs that firms can distribute to health professionals, streamlining certain elements in the documentation of investigational drug studies, and a reduction in both environmental impact filings and pre-approval requirements in tablet manufacture.
1996
Federal Tea Tasters Repeal Act repeals the Tea Importation Act of 1897 to eliminate the Board of Tea Experts and user fees for FDA's testing of all imported tea. Tea itself is still regulated by FDA.

Saccharin Notice Repeal Act repeals the saccharin notice requirements.

Animal Drug Availability Act adds flexibility to animal drug approval process, providing for flexible labeling and more direct communication between drug sponsors and FDA.

Food Quality Protection Act amends the Food, Drug, and Cosmetic Act, eliminating application of the Delaney proviso to pesticides.
1997
Food and Drug Administration Modernization Act reauthorizes the Prescription Drug User Fee Act of 1992 and mandates the most wide-ranging reforms in agency practices since 1938. Provisions include measures to accelerate review of devices, regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods.
1998
FDA promulgates the Pediatric Rule, a regulation that requires manufacturers of selected new and extant drug and biological products to conduct studies to assess their safety and efficacy in children.

Mammography Quality Standards Reauthorization Act continues 1992 Act until 2002.

First phase to consolidate FDA laboratories nationwide from 19 facilities to 9 by 2014 includes dedication of the first of five new regional laboratories.
1999
ClinicalTrials.gov is founded to provide the public with updated information on enrollment in federally and privately supported clinical research, thereby expanding patient access to studies of promising therapies.

A final rule mandates that all over-the-counter drug labels must contain data in a standardized format. These drug facts are designed to provide the patient with easy-to-find information, analogous to the nutrition facts label for foods.
2000
The U. S. Supreme Court, upholding an earlier decision in Food and Drug Administration v. Brown & Williamson Tobacco Corp. et al., ruled 5-4 that FDA does not have authority to regulate tobacco as a drug. Within weeks of this ruling, FDA revokes its final rule, issued in 1996, that restricted the sale and distribution of cigarettes and smokeless tobacco products to children and adolescents, and that determined that cigarettes and smokeless tobacco products are combination products consisting of a drug (nicotine) and device components intended to deliver nicotine to the body.

Federal agencies are required to issue guidelines to maximize the quality, objectivity, utility, and integrity of the information they generate, and to provide a mechanism whereby those affected can secure correction of information that does not meet these guidelines, under the Data Quality Act.

Publication of a rule on dietary supplements defines the type of statement that can be labeled regarding the effect of supplements on the structure or function of the body.
2002
The Best Pharmaceuticals for Children Act improves safety and efficacy of patented and off-patent medicines for children. It continues the exclusivity provisions for pediatric drugs as mandated under the Food and Drug Administration Modernization Act of 1997, in which market exclusivity of a drug is extended by six months, and in exchange the manufacturer carries out studies of the effects of drugs when taken by children. The provisions both clarify aspects of the exclusivity period and amend procedures for generic drug approval in cases when pediatric guidelines are added to the labeling.

In the wake of the events of September 11, 2001, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 is designed to improve the country's ability to prevent and respond to public health emergencies, and provisions include a requirement that FDA issue regulations to enhance controls over imported and domestically produced commodities it regulates.

Under the Medical Device User Fee and Modernization Act, fees are assessed sponsors of medical device applications for evaluation, provisions are established for device establishment inspections by accredited third-parties, and new requirements emerge for reprocessed single-use devices.

The Office of Combination Products is formed within the Office of the Commissioner, as mandated under the Medical Device User Fee and Modernization Act, to oversee review of products that fall into multiple jurisdictions within FDA.

An effort to enhance and update the regulation of manufacturing processes and end-product quality of animal and human drugs and biological medicines is announced, the current good manufacturing practice (cGMP) initiative. The goals of the initiative are to focus on the greatest risks to public health in manufacturing procedures, to ensure that process and product quality standards do not impede innovation, and to apply a consistent approach to these issues across FDA.
2003
The Medicare Prescription Drug Improvement and Modernization Act requires, among other elements, that a study be made of how current and emerging technologies can be utilized to make essential information about prescription drugs available to the blind and visually impaired.

To help consumers choose heart-healthy foods, the Department of Health and Human Services announces that FDA will require food labels to include trans fat content, the first substantive change to the nutrition facts panel on foods since the label was changed in 1993.

An obesity working group is established by the Commissioner of Food and Drugs, charged to develop an action plan to deal with the nation's obesity epidemic from the perspective of FDA. In March 2004 the group releases "Calories Count: Report of the Obesity Working Group," which addresses issues connected to the food label, obesity therapeutics, research needs, the role of education, and other topics.

The National Academy of Sciences releases "Scientific Criteria to Ensure Safe Food," a report commissioned by FDA and the Department of Agriculture, which buttresses the value of the Hazard Analysis and Critical Control Point (HACCP) approach to food safety already in place at FDA and invokes the need for continued efforts to make food safety a vital part of our overall public health mission.

The Animal Drug User Fee Act permits FDA to collect subsidies for the review of certain animal drug applications from sponsors, analogous to laws passed for the evaluation of other products FDA regulates, ensuring the safety and effectiveness of drugs for animals and the safety of animals used as foodstuffs.

FDA is given clear authority under the Pediatric Research Equity Act to require that sponsors conduct clinical research into pediatric applications for new drugs and biological products.
2004
Project BioShield Act of 2004 authorizes FDA to expedite its review procedures to enable rapid distribution of treatments as countermeasures to chemical, biological, and nuclear agents that may be used in a terrorist attack against the U. S., among other provisions.

Passage of the Food Allergy Labeling and Consumer Protection Act requires the labeling of any food that contains a protein derived from any one of the following foods that, as a group, account for the vast majority of food allergies: peanuts, soybeans, cow's milk, eggs, fish, crustacean shellfish, tree nuts, and wheat.

A ban on over-the-counter steroid precursors, increased penalties for making, selling, or possessing illegal steroids precursors, and funds for preventive education to children are features of the Anabolic Steroid Control Act of 2004.

FDA publishes "Innovation or Stagnation? -- Challenge and Opportunity on the Critical Path to New Medical Products," which examines the critical path needed to bring therapeutic products to fruition, and how FDA can collaborate in the process, from laboratory to production to end use, to make medical breakthroughs available to those in need as quickly as possible.

Based on recent results from controlled clinical studies indicating that Cox-2 selective agents may be connected to an elevated risk of serious cardiovascular events, including heart attack and stroke, FDA issues a public health advisory urging health professionals to limit the use of these drugs.

To provide for the treatment of animal species other than cattle, horses, swine, chickens, turkeys, dogs, and cats, as well as other species that may be added at a later time, the Minor Use and Minor Species Animal Health Act is passed to encourage the development of treatments for species that would otherwise attract little interest in the development of veterinary therapies.

Deeming such products to present an unreasonable risk of harm, FDA bans dietary supplements containing ephedrine alkaloids based on an increasing number of adverse events linked to these products and the known pharmacology of these alkaloids.
2005
Formation of the Drug Safety Board is announced, consisting of FDA staff and representatives from the National Institutes of Health and the Veterans Administration. The Board will advise the Director, Center for Drug Evaluation and Research, FDA, on drug safety issues and work with the agency in communicating safety information to health professionals and patients.
2009
President Obama signs the Family Smoking Prevention and Tobacco Control Act into law. The Tobacco Control Act gives FDA authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health.

FDA Center for Tobacco Products established.

FDA announced a ban on cigarettes with flavors characterizing fruit, candy, or clove.
2011
FDA Food Safety and Modernization Act (FSMA). FSMA provides FDA with new enforcement authorities related to food safety standards, gives FDA tools to hold imported foods to the same standards as domestic foods, and directs FDA to build an integrated national food safety system in partnership with state and local authorities.
2012
Food and Drug Administration Safety and Innovation Act (FDASIA). Expands FDA authorities to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biological products; promotes innovation to speed patient access to safe and effective products; increases stakeholder involvement in FDA processes, and enhances the safety of the drug supply chain.

Medical Device User Fee and Modernization Act (MDUFMA III). As part of FDASIA, reauthorizes user fees from industry to fund reviews of medical devices in exchange for FDA to meet certain performance goals.

In 2012, an outbreak of fungal meningitis linked to a contaminated compounded drug product resulted in the loss of 64 lives and caused more than 751 illnesses. In response, Congress enacted the 2013 Drug Quality and Security Act (DQSA) that insures greater regulatory oversight of facilities creating compounded drugs.
2013
Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA). Establishes and reauthorizes certain programs under the Public Health Service Act and the Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response.

Drug Quality and Security Act. Following an outbreak in 2012 of an epidemic of fungal meningitis linked to a compounded steroid, Congress enacted the Drug Quality Safety and Security Act (DQSA). Among other provisions it outlines steps for an electronic and interoperable system to identify and trace certain prescription drugs throughout the U.S.

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Milestones in U.S. Food and Drug Law History

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From the beginnings of civilization people have been concerned about the quality and safety of foods and medicines. In 1202, King John of England proclaimed the first English food law, the Assize of Bread, which prohibited adulteration of bread with such ingredients as ground peas or beans.

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An Unprecedented Outbreak, a New Science-Based Inspection System In 1993, an outbreak of E. coli O157:H7 occurred in the Pacific Northwest, causing 400 illnesses and four deaths. The public demanded change for safer ground beef products.