FDA Unveils New Steps to Protect Youth by Preventing Access to Flavored Tobacco Products, Announces Plans to Ban Menthol in Cigarettes and Cigars

November 15, 2018

When Commissioner Gottlieb announced FDA's Comprehensive Plan for Tobacco and Nicotine Regulation in 2017, the deadlines for certain deemed products were extended, in part, to allow for the potential benefits of innovative new products to be studied more thoroughly. This deadline was extended under the condition that the youth e-cigarette use numbers would not change for the worse. At the time, FDA was seeing change in the right direction as high school current e-cigarette use had decreased from its peak of 16.0 percent in 2015 to 11.3 percent in 2016 and held steady in 2017.

Unfortunately, the situation has changed drastically in the last year. According to new findings from the 2018 National Youth Tobacco Survey (NYTS) released today, there has been a dramatic increase in youth use of e-cigarettes and other electronic nicotine delivery systems (ENDS): From 2017 to 2018, there was a 78 percent increase in current e-cigarette use among high school students and a 48 percent increase among middle school students. This startling surge we're seeing in youth e-cigarette use is beyond troubling and FDA will not sit idly by while we face the threat of a whole generation getting addicted to these products.

Therefore, today FDA is outlining a new policy framework to address what appear to be the central problems—youth appeal and youth access to flavored tobacco products. FDA will be taking steps on the following product categories:

  • Flavored ENDS products (other than tobacco, mint, and menthol flavors or non-flavored products) that are not sold in an age-restricted, in-person location;
  • Flavored ENDS products (other than tobacco, mint, and menthol flavors or non-flavored products) that are sold online without heightened age verification processes;
  • Flavored cigars;
  • ENDS products that are marketed to kids; and
  • Menthol in combustible tobacco products, including cigarettes and cigars.

FDA intends to issue guidance shortly that provides additional details, including what the agency might consider an "age-restricted" location, what it might consider "heightened" age-verification online, and timelines for when FDA intends to implement these policies. Commissioner Gottlieb has stated that he hopes that in the next 90 days, manufacturers will choose to remove flavored ENDS products from stores where kids can access them and from online sites that do not have sufficient age-verification procedures.

FDA also intends to move forward with proposed rulemaking to ban menthol in cigarettes and all flavors, including menthol, in cigars, on an expedited timeline.

The framework being announced today reflects FDA's aim of providing the right balance between closing the on ramp for kids to become addicted to nicotine while maintaining access to potentially less harmful forms of nicotine delivery for adult smokers seeking to transition away from combustible tobacco products.

This policy framework is an important step toward reversing the epidemic that is underway. FDA will continue to base its actions on the best available science and will continue to take aggressive actions to protect our youth through a wide range of prevention and enforcement actions.

For more information on these new actions, please read FDA Commissioner Dr. Scott Gottlieb's statement and HHS Secretary Alex M. Azar's statement in support of today's announcement.

Former Trump Official: FDA Chief Scott Gottlieb has ‘lost his mind’ over vaping ban

Former Trump Official:  FDA Chief Scott Gottlieb has ‘lost his mind’ over vaping ban
 

Former Trump Official: FDA Chief Scott Gottlieb has ‘lost his mind’ over vaping ban

Matt Braynard is a former Data Chief and Strategist for President Donald Trump, and he also seems to be a very staunch and vocal advocate for vaping.  In a recent interview with The Hill, the ex-Trump official suggests that Commissioner Scott Gottlieb of the U.S. Food and Drug Administration (FDA) must have lost his mind for attempting to regulate the American vaping industry out of business.

Under the direction of Gottlieb, the FDA has been pummeling vaping retailers and manufacturers in recent months with a series of probes, investigations, and site inspections amid accusations of kid-appealing marketing practices.  The FDA also openly suggests this surge in teen vaping will theoretically act as a gateway to adult smoking addiction somewhere in the future. 

Related Article: Citing teen vaping as an ‘epidemic,’ FDA Chief Scott Gottlieb launches investigation

However, FDA officials always fail to make clear how hooking teenagers on combustible cigarettes somehow benefits the American vaping industry in any way whatsoever.  Braynard appears to find the FDA Commissioner’s argument rather ridiculous, as well.

“What the FDA chief is proposing here — Scott Gottlieb — is not to, say, limit teenagers from being able to buy this, it’s not educating people it might be harmful but to banning it entirely for everybody including adults, which seems to me that he has lost his mind.”
 
“(FDA commissioner Gottlieb) is formerly of the AEI [American Enterprise Institute], a very free market institute, and if he just consulted with his former doctor and AEI scholars...who have written extensively on the minimal risks of these nicotine vape products compared to cigarettes – which are incredibly dangerous and have been killing people for over 100 years, (he) would understand that banning this product from the market wholesale will have tremendous costs.  There is great risk reduction by allowing these products on the market.”

This most recent outpouring of support of vaping by Mr. Braynard comes in response to a September 12 press announcement by the FDA calling teen vaping a national “epidemic.”  The press release also states that as many as 1,100 vaping-related businesses across the country recently received official FDA warning letters regarding the sales of juuls and other vaping products to minors.  Another 131 establishments even received financial penalties for repeated misconduct.  The full video of the Braynard interview taking place on September 13 – the day after the FDA press release - can be viewed via The Hill

E-Cigarettes and Public Health Concerns

Axios held an in-depth discussion on the increasing trend among teens using e-cigarettes and what policymakers are doing to address the rise. The practice is commonly known as “vaping.” In this part, FDA Commissioner Dr. Scott Gottlieb outlined steps the agency will be taking in an effort to reduce the number of children using e-cigarettes.

 

https://www.c-span.org/video/?452001-1/fda-commissioner-scott-gottlieb-discusses-cigarettes-public-health-concerns

08/21/2018 - FDA EXTENTION

FDA's Comprehensive Plan for Tobacco and Nicotine Regulation

asd;lfja;dsFDA's comprehensive plan places nicotine, and the issue of addiction, at the center of the agency's tobacco regulation efforts. This plan serves as a multi-year roadmap to better protect youth and help addicted adult smokers quit, significantly reducing tobacco-related disease and death in the U.S. in the years to come.

Key Features of the Comprehensive Plan for Tobacco and Nicotine Regulation

Regulatory Policies on Addiction, Appeal, and Cessation

Seeking evidence and public input on potential FDA regulation:

Increasing access to, and use of, medicinal nicotine products to help people quit

FDA is examining actions and working with sponsors to increase access to, and use of, FDA-approved medicinal nicotine products intended to help smokers quit. The Nicotine Steering Committee held a public hearing in early 2018, which focused on Evaluating Safety and Efficacy of Nicotine Replacement Therapies (NRTs).

Educating the public and correcting misperceptions about nicotine

In December 2017, FDA launched an adult public education campaign, Every Try Counts, which offers messages of support to smokers trying to quit. The campaign encourages smokers to keep practicing the quit because every quit attempt is a step toward success.

Most people—especially smokers trying to quit—know that cigarettes are addictive, but many do not understand the role of nicotine in cigarette addiction. FDA is embarking on an effort to engage stakeholders and the public in an educational dialogue and correct common misperceptions around nicotine and addiction.


Science-Based Review of Tobacco Products

Extending certain compliance dates

The agency extended timelines to submit tobacco product review applications for deemed regulated products that were on the market as of August 8, 2016. The revised timelines afford the agency time to explore clear and meaningful measures to ensure tobacco products are less toxic, appealing, and addictive. In addition, the additional time will allow companies to develop higher quality, more complete applications informed by further guidance from the agency.

  • Applications to market deemed regulated combustible products, such as cigars, pipe tobacco, and hookah tobacco, must now be submitted by August 8, 2021.
  • Applications to market deemed regulated non-combustible products, such as electronic nicotine delivery systems (ENDS) or e-cigarettes, must now be submitted by August 8, 2022.

Requirements from the deeming rule that occurred prior to these new extended compliance dates must still be met. For example, mandatory age and photo-ID checks to prevent illegal sales to minors remain in effect and subject to enforcement by the FDA.

Seeking industry feedback on application process

FDA also plans to seek feedback to improve and enhance industry’s ability to comply with federal tobacco regulations through proposing new foundational rules, hearings seeking public comment and feedback, and guidance documents for regulatory compliance related to:

The FDA also plans to finalize guidance on how it intends to review premarket tobacco applications for ENDS. The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information and webinars.
 

Tobacco Product Application Review - A Public Meeting
October 22-23, 2018
Silver Spring, MD


Implementing product standards for safety

Future efforts will also explore additional product standards that could prevent injuries from known tobacco product risks, including:

The FDA has also begun exploring a product standard for e-cigarettes to help address existing concerns. As part of the standard, the agency will consider, among other things, levels of toxicants and impurities in propylene glycol, glycerin, and nicotine in e-liquids.


Youth Tobacco Prevention Plan

Preventing youth use of, and access to, tobacco products

A focused segment of the Comprehensive Plan, known as the Youth Tobacco Prevention Plan, aims to stop youth use of, and access to, tobacco products—especially e-cigarettes. Significant regulatory and research efforts related to access, marketing, and education are already underway.

 

Additional Resources

08/07/2018 - Study finds nicotine safe, helps in Alzheimer's, Parkinson's

Nicotine, by itself a nonaddictive drug, shows promise in a study. Los Angeles Times

Smoking, of course, damages the lungs and blood vessels, and contributes to an array of health problems, but nicotine — the calming chemical that cigarettes deliver — might actually be good for the aging brain.

Smokers, for example, are less likely to develop Alzheimer's disease — a phenomenon that has long puzzled scientists because smoking contributes to cardiovascular disease, which strongly increases the risk of Alzheimer's.

But closer investigation revealed that smoking doesn't confer the protection; nicotine does.

A study of Alzheimer's patients showed that those who wore nicotine patches were better able to remember and pay attention than those who didn't. Another study showed that nicotine boosted cognitive function in older people who didn't have Alzheimer's, but were showing signs of age-related mental decline.

Nicotine also seems to protect against Parkinson's disease, in which the death of cells in a small area of the brain results in tremors, impairing movement and as well as cognitive difficulties.

So what's going on? How does the dreaded addictive component of cigarettes produce health benefits?

For starters, nicotine by itself isn't very addictive at all, according to Dr. Paul Newhouse, the director of Vanderbilt University's Center for Cognitive Medicine. Nicotine seems to require assistance from other substances found in tobacco to get people hooked.

"People won't smoke without nicotine in cigarettes, but they won't take nicotine by itself," said Newhouse, who has done extensive research into beneficial effects of nicotine on the brain. "Nicotine is not reinforcing enough. That's why FDA agreed nicotine could be sold over the counter. No one wants to take it because it's not pleasant enough by itself. And it's hard to get animals to self-administer nicotine the way they will with cocaine."

Nicotine is chemically similar to acetylcholine, a neurotransmitter in the brain that declines in Alzheimer's disease. Drugs such as Aricept help people with Alzheimer's by boosting brain levels of acetylcholine. Apparently, nicotine binds to the receptors in the brain normally occupied by acetylcholine, which benefits people who need more, but it has no apparent effect on those who don't.

"Nicotine doesn't appear to enhance normal people," Newhouse said, "but in people who show some degree of cognitive impairment, nicotine appears to produce a modest but measurable effect on cognitive function, particularly in areas of attention and, to some extent, memory."

Newhouse and his colleagues are testing nicotine to see if it improves other cognitive problems like the mental fogginess known as "chemo brain" that afflicts cancer patients undergoing chemotherapy. They've also started a study of adults with Down syndrome, who almost always develop Alzheimer's disease by the time they reach middle age. Even people with HIV, which appears to cause accelerated cognitive decline, may benefit.

What makes nicotine especially attractive as a treatment is the fact it causes virtually no side effects, according to Newhouse.

"It seems very safe even in nonsmokers," he said. "In our studies we find it actually reduces blood pressure chronically. And there were no addiction or withdrawal problems, and nobody started smoking cigarettes. The risk of addiction to nicotine alone is virtually nil."

Tom Valeo writes on health matters. He can be reached at tom.valeo@gmail.com.

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