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FDA Finalizes Enforcement Policy on Unauthorized Flavored Cartridge-Based E-Cigarettes That Appeal to Children, Including Fruit and Mint

January 2, 2020

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

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 (FDA) 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 exit disclaimer icon 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 exit disclaimer icon 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 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 exit disclaimer icon 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.

Contact: HHS Press Office
202-690-6343
media@hhs.gov

https://www.hhs.gov/about/news/2020/01/02/fda-finalizes-enforcement-policy-unauthorized-flavored-cartridge-based-e-cigarettes.html
Comments | Posted By Wholesale Vaping Supply

E-Cigarettes: The HHS Smoking Gun

Friday, December 20, 2019 10:12:24 AM America/New_York

For months, the Department of Health and Human Services (HHS) has been telling us that young people are becoming hooked on flavored e-cigarettes. Now, we know that not only was HHS wrong, but they knew better and were outrightly dishonest to the American public.

After months of sitting on the information, the CDC finally released the National Youth Tobacco Survey (NYTS) results, and unsurprisingly, the responses confirmed that vaping flavors are not at the root of the youth smoking crisis in this country.

According to the published data, barely one in five youths cited flavors, such as mint, candy, fruit or chocolate, as the reason they picked up vaping products. In fact, they ranked flavors just as important to them than their ability to “do tricks” with their vaping pens, like blowing smoke rings or making shapes. The reasons cited by teens ahead of those two categories and leading the charge in youth usage of vaping products, at 55.3 percent, was simply that they were “curious about them.”

Until now, the FDA and the administration have been staunchly blaming flavored vaping products for the spike in youth use, claiming that flavors have made the products more attractive to teenagers. Even though these survey results prove the opposite to be true, this empirical evidence did not come out and did not remove culpability from flavored products.

The newly released data also begs the question of how long has HHS had access to these results. The flavor ban was first proposed by President Trump on September 11th, but before that, the FDA had publicly blamed flavors for the crisis multiple times.

These survey results prove that not only has the conversation been unjustly manipulated by the government, but the subsequently proposed flavor regulation has the power to kill thousands of American jobs, without sound reasoning to back up the decision. Banning flavors will undoubtedly and unfairly punish well-intentioned companies in the vaping space, force former smokers to return to old habits, and potentially catalyze a black market of illicit products.

Most importantly and less recognized, these regulations will without question cost American lives. Data shows that e-cigarettes are 95% safer than smoking tobacco products and, compared to prescribed alternatives, are almost twice as effective in getting smokers off traditional cigarettes – potentially saving millions of lives. We hope that HHS cares about these lives.

The FDA claims to pride itself on being a fact-driven organization that uses statistics and hard data to come to conclusions. If that is truly the case, then the current data, combined with former data showing that kids overwhelming rank menthol, a “non-flavor” as their favorite, reveals the hard-and-fast facts that they have been ignored and shielded from the public.

The government bureaucracy has kept the American public in the dark in favor of politics. Not only that, but it turned out to be terrible politics, considering a flavor ban has considerable power to hurt Trump’s reelection, with polls showing 11 percent of Trump’s supporters are less likely to vote for a candidate who backs a flavor ban.

The needless domino effect of consequences that would result from this blatantly anti-business regulation would be catastrophic for the country. Going forward, we can only hope the administration leans on facts. Rather than haphazardly picking winners and losers in this situation, it should not continue along the path toward a nationwide flavor ban.

If safety is a concern to the FDA, then Americans deserve better.

Comments | Posted By Wholesale Vaping Supply

Is the FDA about to ban all but two flavors?

Wednesday, November 6, 2019 10:05:35 AM America/New_York

A Message from Casaa

On Monday, November 4, or early in the week, we are anticipating an announcement from the Trump Administration regarding FDA guidance about sales of flavored vapor products. According to recent reports, this guidance is expected to go as far as banning every flavor other than tobacco and menthol. In spite of years of communications from consumers and meetings with industry stakeholders, it is clear that officials remain unknowledgeable about how the vapor industry functions and what customers need.

Two flavors will not sustain independent vapor retailers and
will unnecessarily make vaping less attractive
to people who want to switch away from smoking.


The White House needs to hear from adult vapers and anyone who loves a vaper! A flavor ban won’t protect our children, but it will kill their parents.

We need to 
Light Up The Switchboard
At The White House!

Ph: 202-456-1111
(Comment Line)
or
202-456-1414
(Switchboard)


On your call:

  • The operator will likely ask where they can direct your call
  • Simply tell them that flavored vapor products saved your life,
  • Tobacco and Menthol aren't enough to save small businesses or help people quit smoking; and,
  • tell them “We Vape, We Vote.

Be polite, be brief, and say thank you.

 


Do you want timely alerts about this issue and information about how you can do more?

Comments | Posted By Casaa

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