FDA announces new steps to curb youth tobacco use

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.

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.