What’s more, it’s unclear what exactly Gottlieb is looking for the industry to do. Vapor companies are not marketing to minors, and the large, established companies already have programs in place to prevent youth purchases. Plus, limiting access to ENDS, or taking the products off the market entirely, has the potential to cause harm, as Michael Siegel, a professor at the Boston University School of Public Health, routinely states in his blog: “Juul is helping hundreds of thousands of smokers to quit and perhaps save their lives.”
Those with experience in the regulatory arena point out that despite alarming media coverage, swift and severe action from the agency is unlikely. “Rightly or wrongly, the agency has zeroed in on flavors being at the center of [youth appeal] for vapor products, and combustible products as well,” says Cushman. “But they seem to be taking it in stage, which is more measured than perhaps than what has been portrayed broadly.”
Going for Guidance
In the near term, the industry is expecting the FDA to issue a guidance document outlining their thinking. Based on Commissioner Gottlieb’s remarks, many in the industry expect that guidance to focus on limiting the sale of flavored products to age-restricted venues, such as tobacco shops. That path, however, could prove problematic. “Because guidance documents are non-binding, we don’t know how retailers will react,” explains Cushman.
“Within the Tobacco Control Act there are restrictions on how the FDA can limit face-to face sales of tobacco products in certain retail establishments. So if the FDA moves forward, they will be threading that needle to come up with a policy that will not be immediately subject to lawsuits. There are different ways retailers could respond. If, for example, you look at it as non-binding and move forward by acting as if it is not there, you may open yourself up to enforcement action. That would then set you up to be able to challenge the policy by arguing, ‘They said this was guidance, but they are actually enforcing under this guidance.’”
And, while the guidance document is expected to be followed by a rule-making proposal, that will be a lengthy ordeal for the already-overtaxed FDA. “It will be a multi-year process, and within that process the industry will have significant input as to how the FDA will approach this,” says Cushman. “Because of the process involved and the sheer size and importance of the types of rules they are talking about, you tend to have a longer comment period and time for the agency to review these voluminous and typically very dense comments. So you have a process that can take years. In the meantime, you will likely see more FDA action in other areas that don’t get as much play in the headlines, harmful and potentially harmful constituent testing, PMTA filing guidance documents, etc.”
Whatever rule-making proposal does surface may well be less dramatic than current headlines suggest, she adds. “I think it will be a more measured approach because of the burden on the FDA scientifically to provide backup for whatever they put forward. Because of the handcuffs on the agency from a procedural standpoint, they would have a high hurdle to go full bore on a flavor ban right away.”
Still, the vapor community is already rallying, with both consumers who vape and those whose livelihoods are irrevocably tied to the future of vaping protesting these threats. A recent study published in the New England Journal of Medicine confirmed what most already believed to be true—that ENDS are far more effective than other nicotine substitutes at helping smokers quit. In fact, according to the study, the rate of success is twice as high for ENDS users than those who use patches, gum or other methods.
Dr. Neal L. Benowitz, who is the chief of clinical pharmacology at the University of California, San Francisco, and an expert in nicotine absorption and tobacco-related illnesses, has called the report a “seminal study.” While acknowledging the importance of protecting kids from e-cigarettes and smoking cessation, Benowitz and other health researchers also note that smoking cessation is equally critical, given that tobacco use causes nearly 6 million deaths worldwide each year, including 480,000 in the United States, according to the U.S. Centers for Disease Control and Prevention.
Ultimately, the FDA is charged with finding a way to balance those two health priorities. As Tony Abboud, executive director of the Vapor Technology Association noted in a rebuttal to Gottlieb: “Decisions of this magnitude must be made on science, not emotion. That is [the] FDA’s charge. Does [the] FDA really want millions of Americans to return to smoking cigarettes?”
This story first appeared in the March/April 2019 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.
– Story Jennifer Gelfand, editor-in-chief of Tobacco Business Magazine.