FDA NewsPerspective

FDA announces new steps to curb youth tobacco use

The FDA announced today that to get youth to stop smoking, it will revisit significant parts of two policies that restrict access to newly regulated non-combustible tobacco products, electronic nicotine delivery systems, and e-cigarettes.

“The changes I seek would protect kids by having all flavored [electronic nicotine delivery systems] products (other than tobacco, mint and menthol flavors or nonflavored products) sold in age-restricted, in-person locations, and, if sold online, under heightened practices for age verification,” FDA commissioner Scott Gottlieb, MD, said in a press release.

The federal agency said it is taking another look at policies that extend the premarket application compliance date for newly regulated non-combustible tobacco products, electronic nicotine delivery systems (ENDS), and e-cigarettes to August 2022, and oversee most flavored ENDS that are sold online without additional, heightened age verification and other restrictions in place.

“These changes will not include mint- and menthol-flavored ENDS. This reflects a careful balancing of public health considerations,” Gottlieb said in the release. “Among all ENDS users, data suggests that mint- and menthol-flavored ENDS are more popular with adults than with kids. Any approach to mint- and menthol-flavored ENDS must acknowledge the possibility that the availability of these flavors in ENDS may be important to adult smokers seeking to transition away from cigarettes.”

“Moreover, I recognize that combustible cigarettes are still sold in menthol flavor, including in convenience stores. I don’t want to create a situation where the combustible products have features that make them more attractive than the non-combustible products. Or a situation where those who currently use menthol-flavored cigarettes might find it less attractive to switch completely to an e-cigarette,” he added.

Gottlieb also said in today's announcement that he proposes prohibiting flavors in cigars, and that the FDA intends to look into banning menthol in combustible tobacco products, including cigars and cigarettes.

The AAP said Gottlieb's newest proposals regarding e-cigarettes do not go far enough.

“Even with new sales restrictions announced today by FDA preventing flavored e-cigarettes from being sold at certain brick and mortar storefronts, teens will still find ways to access them. E-cigarette products that appeal to children have no business in the marketplace, period. FDA must take stronger action to protect young people,” Colleen A. Kraft, MD, MBA, FAAP, and president, AAP, said in a statement.

Conversely, the American College of Cardiology was encouraged by the FDA’s latest announcement.

The FDA announced today that to get youth to stop smoking, it will revisit significant parts of two policies that restrict access to newly regulated non-combustible tobacco products, electronic nicotine delivery systems, and e-cigarettes
Source:Shutterstock

“The FDA’s announcement restricting the sale of flavored e-cigarettes and other tobacco products shows they are ready to do their part in making tobacco products less available to our children. Let’s do our part to make sure they don’t become our future patients,” C. Michael Valentine, MD, FACC, president of the American College of Cardiology, said in a statement.

The latest FDA announcement comes on the heels of a new CDC report that found current e-cigarette use increased 78% among high school students and 48% among middle school students from 2017 to 2018. The data also showed 1.5 million more students are using e-cigarettes this year vs. last year.

In addition, NBC News reported that e-cigarette maker Juul took a preemptive step this week by removing most of its flavored products from retail stores and is scaling back its social media presence.

Juul has been under significant FDA scrutiny this year, most recently when the FDA took control of more than 1,000 pages of documents in a surprise inspection of Juul Labs earlier this fall. An FDA spokesperson told Healio Family Medicine the paperwork was connected to Juul’s marketing and sales practices.

The FDA under the Trump administration has made curtailing youth tobacco use one of its top priorities. Earlier this year, it conducted undercover blitzes targeting retailers who sell to minors and it previously announced plans to expand the “The Real Cost” campaign, which includes educational information on the dangers of ENDS and e-cigarettes for teenagers. – by Janel Miller

Disclosure: Gottlieb is FDA commissioner, Kraft is president of AAP, Valentine is president of the American College of Cardiology.

The FDA announced today that to get youth to stop smoking, it will revisit significant parts of two policies that restrict access to newly regulated non-combustible tobacco products, electronic nicotine delivery systems, and e-cigarettes.

“The changes I seek would protect kids by having all flavored [electronic nicotine delivery systems] products (other than tobacco, mint and menthol flavors or nonflavored products) sold in age-restricted, in-person locations, and, if sold online, under heightened practices for age verification,” FDA commissioner Scott Gottlieb, MD, said in a press release.

The federal agency said it is taking another look at policies that extend the premarket application compliance date for newly regulated non-combustible tobacco products, electronic nicotine delivery systems (ENDS), and e-cigarettes to August 2022, and oversee most flavored ENDS that are sold online without additional, heightened age verification and other restrictions in place.

“These changes will not include mint- and menthol-flavored ENDS. This reflects a careful balancing of public health considerations,” Gottlieb said in the release. “Among all ENDS users, data suggests that mint- and menthol-flavored ENDS are more popular with adults than with kids. Any approach to mint- and menthol-flavored ENDS must acknowledge the possibility that the availability of these flavors in ENDS may be important to adult smokers seeking to transition away from cigarettes.”

“Moreover, I recognize that combustible cigarettes are still sold in menthol flavor, including in convenience stores. I don’t want to create a situation where the combustible products have features that make them more attractive than the non-combustible products. Or a situation where those who currently use menthol-flavored cigarettes might find it less attractive to switch completely to an e-cigarette,” he added.

Gottlieb also said in today's announcement that he proposes prohibiting flavors in cigars, and that the FDA intends to look into banning menthol in combustible tobacco products, including cigars and cigarettes.

The AAP said Gottlieb's newest proposals regarding e-cigarettes do not go far enough.

“Even with new sales restrictions announced today by FDA preventing flavored e-cigarettes from being sold at certain brick and mortar storefronts, teens will still find ways to access them. E-cigarette products that appeal to children have no business in the marketplace, period. FDA must take stronger action to protect young people,” Colleen A. Kraft, MD, MBA, FAAP, and president, AAP, said in a statement.

Conversely, the American College of Cardiology was encouraged by the FDA’s latest announcement.

The FDA announced today that to get youth to stop smoking, it will revisit significant parts of two policies that restrict access to newly regulated non-combustible tobacco products, electronic nicotine delivery systems, and e-cigarettes
Source:Shutterstock

“The FDA’s announcement restricting the sale of flavored e-cigarettes and other tobacco products shows they are ready to do their part in making tobacco products less available to our children. Let’s do our part to make sure they don’t become our future patients,” C. Michael Valentine, MD, FACC, president of the American College of Cardiology, said in a statement.

The latest FDA announcement comes on the heels of a new CDC report that found current e-cigarette use increased 78% among high school students and 48% among middle school students from 2017 to 2018. The data also showed 1.5 million more students are using e-cigarettes this year vs. last year.

In addition, NBC News reported that e-cigarette maker Juul took a preemptive step this week by removing most of its flavored products from retail stores and is scaling back its social media presence.

Juul has been under significant FDA scrutiny this year, most recently when the FDA took control of more than 1,000 pages of documents in a surprise inspection of Juul Labs earlier this fall. An FDA spokesperson told Healio Family Medicine the paperwork was connected to Juul’s marketing and sales practices.

The FDA under the Trump administration has made curtailing youth tobacco use one of its top priorities. Earlier this year, it conducted undercover blitzes targeting retailers who sell to minors and it previously announced plans to expand the “The Real Cost” campaign, which includes educational information on the dangers of ENDS and e-cigarettes for teenagers. – by Janel Miller

Disclosure: Gottlieb is FDA commissioner, Kraft is president of AAP, Valentine is president of the American College of Cardiology.

    Perspective
     Cristine Delnevo

    Cristine Delnevo

    Nov. 15 was the Great American Smokeout and it was on this day that the FDA announced their plans to protect our nation’s young people from the harms of tobacco. 

    While the headlines on FDA’s long-awaited announcement highlighted the rapid increase in vaping among young people, the real story here is the long overdue agency action on combustible tobacco products. Tobacco products possess different levels of risk and inhaling combusted tobacco smoke is the most dangerous tobacco use behavior. Indeed, combustible tobacco use, that is cigarettes and cigars, remains the single largest preventable cause of disease and premature death in the U.S. and worldwide.

    At the opposite end of the risk spectrum are e-cigarettes. The 2018 National Academy of Medicine, Engineering and Science concluded that there is substantial evidence that exposure to potentially toxic substances from e-cigarettes is significantly lower compared with combustible tobacco cigarettes. And the 50th anniversary of the Surgeon General’s Report on Tobacco acknowledged that reducing tobacco-caused disease might be aided by safer substitutes for the cigarette and explicitly cited e-cigarettes. The traditional clinical message that simply warns that “all tobacco use is harmful” without acknowledging a continuum of risk, no longer works. Our messaging must be nuanced, and likewise, FDA’s strategies must be nuanced. The most meaningful components of FDA’s plan in the context of reducing disease, disability and death from tobacco are banning flavors in cigars and cigarettes, including menthol. Menthol cigarettes are disproportionately smoked by young people, minorities and people with mental health conditions. Moreover, the data suggest menthol cigarettes facilitate smoking initiation and are harder to quit. The FDA has been exploring banning menthol for nearly a decade it is time for the agency to take action. 

    FDA Commissioner Scott Gottlieb stated that he didn’t “want to create a situation where the combustible products have features that make them more attractive than the non-combustible products.” In other words, it would be very bad to ban flavors in e-cigarettes while continuing to allow flavored cigars to continue to be sold, cheaply and easily accessible to young people. Flavored cigars are overwhelmingly preferred by young people, and like menthol cigarettes, are also favored by minorities. FDA’s call to action will take meaningful steps to address flavors in combustible tobacco products. While Juul and other flavored e-cigarettes might be capturing the media’s attention, public health and medical professionals need to take a broader view, like the FDA, and consider the diverse tobacco marketplace. Primary care physicians must also recognize the continuum of risk as well as the complex tobacco use behaviors of youth and young adult patients, and ask their patients about all tobacco products: not just ones grabbing the headlines.

    • Cristine Delnevo, PhD, MPH
    • director, Center for Tobacco Studies, Rutgers School of Public Health
      co-leader, Cancer Prevention and Control Research Program at Rutgers Cancer Institute of New Jersey

    Disclosures: Delnevo reports no relevant financial disclosures.

    Perspective
    Harold Farber

    Harold Farber

    E-cigarette use is skyrocketing among kids. In a largely unregulated marketplace the e-cigarette manufacturers set out to make products and marketing that appealed to young people. Fruit and candy flavors proliferated. Celebrities served as role models. Vape tricks became the in thing. In this unregulated marketplace, JUUL introduced a product that conquered the market using a highly addictive nicotine salt — which they were so proud of that they patented it. Then they added cool flavors and put it in a discreet device resembling a USB drive that could be easily used in class. If you bothered to look, you could see the writing on the wall. E-cigarettes, including JUUL, are addicting a new generation. Why the FDA has taken until now to realize this is beyond me. 

    The 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA authority to regulate all tobacco products and is charged with the authority to adopt evidence-based tobacco product standards appropriate for the protection of the public health. Although the FDA has the authority to conduct premarket reviews of tobacco products introduced into the market after February 2007, the FDA has yet to use this authority.    

    E-cigarettes have become the new gateway drug for youth. Once they start on e-cigarettes, their chances of going on to other forms of tobacco — cigarettes, cigars, hookah, dip, etc. — is much higher. This again should be no surprise; a rising tide lifts all boats.

    Do e-cigarettes really help adult smokers? Although there are anecdotal reports of adults who have stopped smoking with e-cigarettes, the results of large population studies suggest that, compared to adult smokers who don’t use e-cigarettes, adult smokers who use e-cigarettes are less likely to stop smoking — and may be smoking more. Rather than an off-ramp for tobacco and nicotine addiction, e-cigarettes appear to be an on-ramp to start, prolong and perpetuate tobacco and nicotine addiction. Unfortunately, e-cigarettes do not live up to the hype as an effective harm reduction strategy.

    Although I am happy that the FDA is taking some initial actions to protect children, the agency is not yet doing what it is authorized to do and needs to do. Premarket review of tobacco products placed on the market after February of 2007 needs to be put in place now, not delayed until 2022. If effective premarket review was in place in August 2016 after the FDA issued its “deeming rule” to extend its authority over all tobacco products, the JUUL epidemic could have been prevented.

    Youth-appealing flavors — including menthol — need to be banned from all tobacco products. Currently, only cigarettes have restrictions on what flavorings can be added. Impatient in waiting for the FDA to take needed action, the city of San Francisco has banned flavors — including menthol — from tobacco and nicotine products. If the FDA fails to take action, in order to protect our children, state and local governments must. 

    Although the FDA is not authorized to raise the age for sale of tobacco and nicotine products above 18 years, raising the legal age for sale to 21 (called Tobacco 21) when combined with enforcement of those restrictions, has been shown to be an effective approach to reducing youth tobacco and nicotine initiation and addiction — even when implemented at the local level. To date, 360 cities and counties in 22 states have implemented Tobacco 21 laws.

    It is time that we started treating youth smoking as the severe public health crisis that it is. The FDA is starting to realize this and is taking some initial actions, but our children need much more. We need more than tentative actions, warning letters, and hoping that tobacco product manufactures will abandon the youth market which is key to their market share and growth. We need effective regulation that is aggressively enforced. We need effective education that changes the image of tobacco and nicotine products from glamour, attractiveness, rebelliousness, etc., to the truth of addiction, illness, breathlessness and premature death. It is about time. Our children deserve no less.

    • Harold Farber, MD, MSPH, ATSF
    • Associate professor of pediatrics, pulmonary section Baylor College of Medicine and Texas Children’s Hospital, Houston, Texas

    Disclosures: Healio Family Medicine was unable to determine Farber's relevant financial disclosures prior to publication.