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Ban of flavored e-cigarettes

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The Trump administration is banning flavored vape products that appeal to children. The Food and Drug Administration said Thursday that manufacturers will have 30 days to stop making and selling cartridge-based vaping devices, including mint-, fruit- and dessert-flavored electronic cigarettes.

The ban does not apply to menthol or tobacco flavors. It also excludes so-called open systems, sometimes known as vape pens, which require a user to manually fill the e-cigarette with liquid. Instead, the new rules focus on vaping products with pre-filled cartridges, which FDA Commissioner Stephen Hahn described in a statement announcing the ban as "both easy to use and easily concealable."

Together, those exemptions represent a significant retreat from President Donald Trump's September pledge to crack down on vaping following a rash of deaths and respiratory illnesses linked to vaping. That plan would have banned all vaping flavors - including menthol - from all types of e-cigarettes. But that effort stalled after vaping proponents and lobbyists pushed back and White House advisers told the president that an all-out flavor vape ban could cost him votes.

Industry groups including the Vapor Technology Association had launched an aggressive social media campaign - #IVapeIVote - contending that the plan would force the closure of vaping shops, eliminating jobs and sending users of electronic cigarettes back to tobacco products. The group took out a six-figure ad buy in Florida last week, aiming to reach Mr. Trump while he was spending his holidays there.

The new policy will preserve a significant portion of the multibillion-dollar vaping market. The narrower scope of the FDA rules is also likely to please tobacco giant Altria, which owns e-cigarette maker Juul Labs, as well as thousands of vape shop owners around the country who sell the open systems, which allow users to mix customized flavors. Sales of these devices represent an estimated 40% of the U.S. vaping business, with sales across some 15,000 to 19,000 shops.

As of January, 55 people have died from vaping-related illnesses and more than 2,500 have been hospitalized, according to the U.S. Centers for Disease Control and Prevention.

Teens vaping marijuana on the rise

The flavor ban applies to e-cigarettes that use pre-filled nicotine cartridges mainly sold at gas stations and convenience stores. Juul is the biggest player in that market, but it previously pulled all of its flavors except menthol and tobacco after coming under intense political scrutiny. Many smaller manufacturers continue to sell sweet, fruity flavors like "grape slushie," "strawberry cotton candy" and "sea salt blueberry."

The FDA justified exempting a large chunk of the vaping market with figures showing that teenagers strongly preferred fruit or dessert flavors over menthol or tobacco. But youth health advocates were quick to criticize the rule, saying it doesn't go far enough.

"Only the elimination of all flavored e-cigarettes can end the worsening youth e-cigarette epidemic and stop e-cigarette companies from luring and addicting kids with flavored products," said Matthew Myers, of the Campaign for Tobacco-Free Kids, in a statement.

Myers's group and others have long opposed all flavors in tobacco products, including menthol in traditional cigarettes. They argue that teenagers who vape will simply shift to using menthol if it remains on the market.

The American Medical Association has called for a full ban of all vaping products that don't work as a smoking cessation device.

Technically, all e-cigarettes currently on the market are illegal, Alex Azar, secretary for Health and Human Services, told reporters on a phone call Thursday, but they remain available because the government has chosen not to crack down while it determines if the products can help adults quit cigarettes.

"We believe that remains a possibility, but it should not come as an excuse for being an on-ramp for children, which is occurring today," Azar said.

E-cigarette tax could deter smokers from quitting, study says

Despite the exemptions, the new policy represents the federal government's biggest step yet to combat a surge in teen vaping that officials fear is hooking a generation of young people on nicotine. In the latest government survey, more than 1 in 4 high school students reported using e-cigarettes in the previous month, despite federal law banning sales to those under 18.

Late last month Mr. Trump signed a law raising the minimum age to purchase all tobacco and vaping products from 18 to 21 nationwide. He hinted at the ban earlier this week.

"We'll be taking it off, the flavors for a period of time - certain flavors," he said on Tuesday. "We're going to protect our families, we're going to protect our children and we're going to protect the industry."

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FDA bans some vaping products, including fruit and mint flavors

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The Trump administration is banning flavored vape products that appeal to children. The Food and Drug Administration said Thursday that manufacturers will have 30 days to stop making and selling cartridge-based vaping devices, including mint-, fruit- and dessert-flavored electronic cigarettes. The ban does not apply to menthol or tobacco flavors.

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Only a strong public health system can conquer nicotine addiction.

Video

Credit Credit... By Nicholas Konrad

The editorial board is a group of opinion journalists whose views are informed by expertise, research, debate and certain longstanding values. It is separate from the newsroom.

The nation is facing two distinct vaping-related health crises: surging e-cigarette use among teenagers and a lung-injury outbreak that has sickened more than 2,000 people and killed at least 40. Both have exposed yawning gaps in the nation's public health apparatus. But instead of closing those gaps, policymakers have turned to a much more straightforward fix: banning products.

A federal ban on flavored e-cigarettes is reportedly in the offing. Several states have already enacted their own flavor bans. And Massachusetts and several California cities have taken steps to outlaw e-cigarettes altogether.

The impulse to remove e-cigarettes from the market is understandable. The Food and Drug Administration's hands-off approach to vaping and e-cigarette regulation has backfired badly. The Centers for Disease Control and Prevention - and state and local health departments around the country - are struggling to pick up the slack. And after more than a decade, neither federal agency has a clear sense of the overall risks and benefits of these products.

But prohibition is not a good long-term solution, for a number of reasons. Such measures are not guaranteed to prevent teenagers from getting e-cigarettes. And they would almost certainly force people who already use these products, including roughly 11 million adults, to choose between traditional cigarettes (which remain widely available, despite being deadlier than e-cigarettes) and black-market vaping products.

Because these black market products are a leading suspect in the lung-injury outbreak, product bans are more likely to exacerbate this crisis than to mitigate it.

The better, if more complicated, option would be to build a public health system that's strong enough to combat all nicotine addiction in the long term. That, in turn, could help drive a cultural shift for e-cigarettes akin to the shift that took place for traditional cigarettes. Policy changes and growing public awareness - not product bans - helped turn what was considered a chic, stress-relieving diet tool into what is now more commonly viewed as a smelly, overpriced cancer stick.

With sustained and careful investment, e-cigarettes might become nothing more than a harm-reduction option for adult smokers - no more appealing to teenagers than a nicotine patch or a piece of nicotine gum. Here are some ideas for making that vision a reality.

Treat e-cigarettes like cigarettes. Traditional cigarettes and other tobacco products are already bound by a number of rules - including special taxes, advertising restrictions and age-verification requirements - that helped sharply lower both youth and adult smoking rates in recent decades. E-cigarette makers have evaded similar regulations, through a combination of lawsuits and intensive lobbying. (Among other things, the vaping industry has argued that e-cigarettes are not tobacco products because they contain only nicotine - but nicotine comes exclusively from the tobacco plant.) Congress could stop such antics with new legislation. A recently passed House bill that would mandate age verification for all online e-cigarette purchases is a welcome step in the right direction. Additional laws are needed to ensure that any rules applying to tobacco products also apply to e-cigarettes.

Learn from Britain. So far, the country has managed to make e-cigarettes available for adults who want to quit using regular cigarettes without triggering an epidemic of nicotine dependence among its youth. Public health experts say at least part of that success is due to the way these products are regulated in Britain. Packaging and advertising are tightly restricted - no bright, colorful labels or kid-friendly media campaigns allowed. And the nicotine content is capped. In America, where there are no such limits, e-cigarettes often contain more than twice as much nicotine as they do in Britain and are still being sold in ways designed to appeal to young children.

Invest in public health. The C.D.C. and state and local health departments across the country are struggling to hold the line on public health gains made over the past century. For tobacco control, that means educating the public about the risks of nicotine addiction and countering the tobacco industry's efforts to lure young users. It also means detecting outbreaks of vaping-related illness or injury, pinpointing the causes of those outbreaks and advising governments on how to respond. This crucial work is in desperate need of a funding boost. The House has approved $40 million to increase the C.D.C.'s tobacco control efforts and $100 million to upgrade the agency's data system, which is currently so antiquated it relies on fax machines and CD-ROMs. The Senate should follow suit.

Invest in research. There remains much we don't know about e-cigarettes. Are these products truly effective at helping people quit smoking, and is there a way to maximize that effectiveness? For example, do flavors that attract children also help adults quit? Would adults be more likely to quit if e-cigarettes were paired with other supports, like counseling? How safe is long-term e-cigarette use, and are some products safer than others? What are the risks to people who end up using both electronic and traditional cigarettes? What about those who switch completely to e-cigarettes but end up smoking much more because vaping is easier to get away with indoors? Health officials need answers to these questions to set effective policies.

Maintain pressure. Scientists and universities have refused to take "research" money from companies that make e-cigarettes; advertising agencies and health and wellness companies are pledging to do the same. These movements reflect a growing public wariness that is itself a powerful check on the industry. For example, it was after a tsunami of bad press - investigations, congressional hearings, lawsuits - that Juul, the nation's leading e-cigarette maker, closed some of its social media accounts, put in place an age-verification system and stopped selling many of its flavored pods.

Critics are right to be skeptical of such voluntary measures - the tobacco industry has a terrible track record of self-policing. But the fact that the company took these steps at all, after fighting them so aggressively for so long, is proof that even while regulatory efforts falter, public sentiment can still hold sway.

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Opinion | Banning E-Cigarettes Could Do More Harm Than Good (Published 2019)

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Only a strong public health system can conquer nicotine addiction. The editorial board is a group of opinion journalists whose views are informed by expertise, research, debate and certain longstanding values. It is separate from the newsroom.

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Amid the epidemic levels of youth use of e-cigarettes and the popularity of certain products among children, the U.S. Food and Drug Administration today issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. Under this policy, companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions.

"The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes. HHS is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally," said HHS Secretary Alex Azar. "By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don't provide an on-ramp to nicotine addiction for our youth. We will not stand idly by as this crisis among America's youth grows and evolves, and we will continue monitoring the situation and take further actions as necessary."

"As we work to combat the troubling epidemic of youth e-cigarette use, the enforcement policy we're issuing today confirms our commitment to dramatically limit children's access to certain flavored e-cigarette products we know are so appealing to them - so-called cartridge-based products that are both easy to use and easily concealable. We will continue to use our full regulatory authority thoughtfully and thoroughly to tackle this alarming crisis that's affecting children, families, schools and communities," said FDA Commissioner Stephen M. Hahn, M.D. "Coupled with the recently signed legislation increasing the minimum age of sale of tobacco to 21, we believe this policy balances the urgency with which we must address the public health threat of youth use of e-cigarette products with the potential role that e-cigarettes may play in helping adult smokers transition completely away from combustible tobacco to a potentially less risky form of nicotine delivery. While we expect that responsible members of industry will comply with premarket requirements, we're ready to take action against any unauthorized e-cigarette products as outlined in our priorities. We'll also closely monitor the use rates of all e-cigarette products and take additional steps to address youth use as necessary."

The final guidance outlining the agency's enforcement priorities for electronic nicotine delivery systems (ENDS), such as e-cigarettes and e-liquids, comes as the 2019 National Youth Tobacco Survey (NYTS) results on e-cigarette use show that more than 5 million U.S. middle and high school students are current e-cigarette users (having used within the last 30 days) - with a majority reporting cartridge-based products as their usual brand.

The NYTS survey, which is conducted annually by the FDA in conjunction with the Centers for Disease Control and Prevention, also shows that of current youth e-cigarette users in 2019, approximately 1.6 million were using the product frequently (use on 20 days or more in a 30-day period), with nearly one million using e-cigarettes daily. Additional data from another federal survey further underscore that youth are particularly attracted to e-cigarette flavors such as fruit and mint, much more so than tobacco or menthol flavored e-cigarettes. These overall levels of youth e-cigarette use are particularly concerning because using e-cigarettes puts them at risk for nicotine addiction and other health consequences. In particular, evidence shows that youth exposure to nicotine can adversely affect the developing adolescent brain and that, compared with non-users, youth who use e-cigarettes are more likely to try conventional cigarettes in the future.

On Aug. 8, 2016, all e-cigarettes and other ENDS products became subject to the FDA's tobacco authorities, including the premarket authorization requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act). All e-cigarettes and other ENDS products on the market at that time needed to have authorization from the FDA to be legally marketed. However, as an exercise of its enforcement discretion, the agency had deferred enforcement of the premarket authorization requirements. To date, no ENDS products have been authorized by the FDA - meaning that all ENDS products currently on the market are considered illegally marketed and are subject to enforcement, at any time, in the FDA's discretion.

Beginning 30 days from the publication of the notice of availability of this guidance in the Federal Register, the FDA intends to prioritize enforcement against these illegally marketed ENDS products by focusing on the following groups of products that do not have premarket authorization:

Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);

All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors' access; and

Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.

Cartridge-based ENDS products are a type of ENDS product that consists of, includes, or involves a cartridge or pod that holds liquid that is to be aerosolized when the product is used. For purposes of this policy, a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an ENDS product.

By not prioritizing enforcement against other flavored ENDS products in the same way as flavored cartridge-based ENDS products, the FDA has attempted to balance the public health concerns related to youth use of ENDS products with considerations regarding addicted adult cigarette smokers who may try to use ENDS products to transition away from combustible tobacco products. In addition to data showing that cartridge-based ENDS products are most commonly used among youth, important findings from the 2019 Monitoring the Future survey focusing on youth use of JUUL indicate that youth preference for menthol- and tobacco-flavored e-cigarettes is much lower than that for mint- and fruit-flavored e-cigarettes. Because of the relatively low numbers of youth using both menthol- and tobacco-flavored, cartridge-based ENDS products, these products are not among the current enforcement priorities. However, should the FDA become aware of an increase of youth using any other flavored products (both cartridge-based or otherwise), the agency will take additional steps to address youth use of those products if necessary.

For all other products (cartridge-based or otherwise), including menthol-, tobacco-, and non-flavored ENDS products, the FDA will also prioritize enforcement where the manufacturer fails to take adequate measures to prevent youth access. For example, the FDA will consider whether the manufacturer has implemented adequate programs to monitor retailer compliance with age-verification and sales restrictions or if it has established and enforced penalties against retailers that fail to comply with those programs. The agency also will consider whether the manufacturer uses adequate age-verification technology (or requires that retailers who sell its products use such technology) to prevent underage access to its website and to prevent underage sales through the internet. In addition, consideration will be given to whether the manufacturer limits (or requires retailers who sell its products to limit) the quantity of ENDS products that a customer may purchase within a given period of time.

The FDA also intends to prioritize enforcement with respect to any ENDS products that are targeted to youth or likely to promote use of ENDS by youth. Examples include: products marketed with labeling and/or advertising that resemble kid-friendly foods and drinks such as juice boxes or kid-friendly cereal; products marketed directly to minors by promoting ease of concealing the product or disguising it as another product; and products marketed with characters designed to appeal to youth.

Importantly, the FDA's enforcement priorities are not a "ban" on flavored or cartridge-based ENDS. The FDA has already accepted and begun review of several premarket applications for flavored ENDS products through the pathway that Congress established in the Tobacco Control Act. Manufacturers that wish to market any ENDS product - including flavored e-cigarettes or e-liquids - are required by law to submit an application to the FDA that demonstrates that the product meets the applicable standard in the law, such as whether the product is appropriate for the protection of the public health. If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considering how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale.

The guidance also states that, after May 12, 2020, the FDA intends to also prioritize enforcement against any ENDS products that continue to be sold and for which the manufacturers have not submitted a premarket application. For ENDS products other than those in the three groups described above, if premarket applications are submitted by that date, the FDA intends to continue to exercise enforcement discretion for up to one year pending FDA review of the applications, unless there is a negative action by the FDA on such application or the product is authorized to be marketed by the FDA.

The FDA has demonstrated a deep commitment to taking steps to prevent youth from using and becoming addicted to any tobacco product, including e-cigarettes. This enforcement policy is an important step in the agency's ongoing work to ensure these products are not marketed to, sold to, or used by kids, as outlined in the agency's Youth Tobacco Prevention Plan, including investing in public education campaigns to educate youth about the dangers of e-cigarette use, provide resources to educators, parents and community leaders to prevent youth use, as well as further explore how to help those kids who are already addicted to e-cigarettes quit.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Related Information

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FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint

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Amid the epidemic levels of youth use of e-cigarettes and the popularity of certain products among children, the U.S. Food and Drug Administration today issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors.

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As of October 22, 2019, 34 deaths in patients with e-cigarette, or vaping, product use associated lung injury (EVALI) have been reported to CDC. Of the 29 deaths among patients with EVALI analyzed in today's report, 59% were men and the median age was 45 years. Patients with EVALI who died were older than the overall population of EVALI patients.

Today's MMWR report is the first to describe characteristics of patients with EVALI who died to date, and also updates previous data on all EVALI patient characteristics, including sex, age, and substances used in e-cigarette, or vaping, products.

Among the 19 EVALI patients who died and for whom CDC had available data on substances used, 84% reported any use of THC-containing products, 37% reported any use of nicotine-containing products, 63% reported exclusive use of THC-containing products, and 16% reported exclusive use of nicotine-containing products.
Report adds updated information on patient characteristics
As of October 22, 2019, 49 states, the District of Columbia, and the U.S. Virgin Islands have reported 1,604 cases of EVALI. Data from today's report indicate that patients with EVALI are mostly young, white males. Among patients with available data, 79% were under age 35, 78% were non-Hispanic white, and 70% were males. Additionally, about half of the cases, and two deaths, occurred in patients under age 25 years.

"It is evident from today's report that these lung injuries are disproportionately affecting young people," said Robert R. Redfield, M.D., director of the Centers for Disease Control and Prevention. "As CDC receives additional data, a more defined picture of those impacted is taking shape. These new insights can help bring us a step closer to identifying the cause or causes of this outbreak."

The report also reinforces that THC-containing products continue to play a major role in the outbreak. Among 867 patients with available data on specific e-cigarette, or vaping, product use in the three months preceding symptom onset, 86% reported any use of THC-containing products, 64% reported any use of nicotine-containing products, 52% reported any use of both THC-containing products and nicotine-containing products, 34% reported exclusive use of THC-containing products, and 11% reported exclusive use of nicotine-containing products.
Recommendations
At this time, FDA and CDC have not identified the cause or causes of the lung injuries in these cases, and the only commonality among all cases is that patients report the use of vaping products, including e-cigarettes. No one compound or ingredient has emerged as the cause of these illnesses to date; and it may be that there is more than one cause of this outbreak. We do know that THC is present in most of the samples tested to date, and most patients report a history of THC-containing products. The latest national and state findings suggest products containing THC, particularly those obtained off the street or from other informal sources (e.g. friends, family members, illicit dealers), are linked to most of the cases and play a major role in the outbreak.

As such, we recommend that you do not use e-cigarette or vaping products that contain THC. And since the specific cause or causes of lung injury are not yet known, the only way to assure that you are not at risk while the investigation continues is to consider refraining from use of all e-cigarette andvaping products. Adults addicted to nicotine using e-cigarettes should weigh all risks and benefits, and consider utilizing FDA approved nicotine replacement therapies. They should not turn to or resume using combustible tobacco. There is no safe tobacco product. All tobacco products, including e-cigarettes, carry a risk.

CDC will continue to update guidance, as appropriate, as new data emerges from this complex outbreak.

More information about the investigation is available at www.cdc.gov/lunginjury.

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New CDC Report Provides First Analysis of Lung Injury Deaths Associated with Use of E-cigarette, or Vaping, Products

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As of October 22, 2019, 34 deaths in patients with e-cigarette, or vaping, product use associated lung injury (EVALI) have been reported to CDC. Of the 29 deaths among patients with EVALI analyzed in today's report, 59% were men and the median age was 45 years.

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CBS News. (2020, January 3). FDA bans some vaping products, including fruit and mint flavors. Retrieved February 14, 2020, from https://www.cbsnews.com/news/fda-bans-some-vaping-products-including-fruit-and-mint-flavors/

Commissioner, O. of the. (2020, January 2). FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint. Retrieved February 14, 2020, from https://www.fda.gov/news-events/press-announcements/fda-finalizes-enforcement-policy-unauthorized-flavored-cartridge-based-e-cigarettes-appeal-children

New CDC Report Provides First Analysis of Lung Injury Deaths Associated with Use of E-cigarette, or Vaping, Products. (2019, October 28). Retrieved February 14, 2020, from https://www.cdc.gov/media/releases/2019/p1028-first-analysis-lung-injury-deaths.html

Perrone, M. (2020, January 3). Trump administration bans most flavored e-cigarettes, with major exceptions that benefit vaping companies. Retrieved February 14, 2020, from https://www.chicagotribune.com/business/ct-biz-trump-flavored-vaping-ban-exceptions-20200102-uoyq7xryv5gsjnlej2bzpczyye-story.html