On Friday, the head of the Food and Drug Administration, Scott Gottlieb, took an important first step to reforming the country's dysfunctional approach to tobacco and nicotine regulation.
The e-cigarette industry was bracing itself for near-destruction next year, when deadlines for prohibitively-expensive product applications were due Aug. 8. According to the FDA's own economic analysis, 99 percent of vapor products wouldn't even have had an application put forward, let alone been approved.
This would have led to an unjustifiable state of affairs where cigarettes would still be freely available but almost all e-cigarettes -- which are 95 percent safer, use no tobacco and help people quit smoking -- would be virtually banned.
Unveiling a comprehensive plan for tobacco and nicotine regulation, Gottlieb gave producers and vapers a lifeline. The FDA is extending the deadline for these draconianly expensive and complex applications to Aug. 8, 2022, giving much-needed breathing space to the thousands of businesses that would have had to close next year.
Michael and Carla Bowers, who own vapor businesses in New York City, Yonkers, N.Y., and Connecticut were considering closing shop because of the looming PMTA deadline. Upon hearing Gottlieb's comments, their first words were, "I guess we can renew our leases now."
In addition to the deadline extension, Gottlieb said the FDA plans to issue regulations that will make the product review process "more efficient, predictable, and transparent for manufacturers."
Vaping advocates welcomed the news.
"To say the least, we are relieved by Dr. Gottlieb's announcement. Without Dr. Gottlieb's leadership, over 99 percent of vapor products on the market today would have been banned in fifteen months' time," said Gregory Conley, president of the American Vaping Association.
Mike Hogan, a lobbyist for the Smoke-Free Alternatives Trade Association said he's been fielding calls from members of Congress asking what they think of the announcement. "I just thanked Democrat Congressman (Sanford) Bishop and Republican Senator Ron Johnson's staff for their creating the political space to allow this to happen."
Over the next four years, industry, advocacy groups, and public health officials will be able to weigh in and help the FDA to come up with a regulatory framework for tobacco and nicotine that provides, in the agency's words, "an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes."
This is good news, not just for small businesses, but for public health. If helping smokers quit and reducing the incidence of death and disease is indeed a public policy goal, it's vital that government allows the transition away from smoking to be as easy as possible. The best way to do that is to allow consumers access to safer products they find most effective, which includes e-cigarettes.
Beyond deadline extensions, Gottlieb's statements on Friday showed a welcome new approach from the FDA, noting that "nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes." In other words, the FDA recognizes the fact that it is not the nicotine that kills, but the smoke caused by combustion, and that this will be taken into account when regulating tobacco, vapor, and other reduced risk products.
While this statement may appear obvious, it is of huge significance. By explicitly recognizing that reduced risk nicotine products such as e-cigarettes (and potentially smokeless tobacco) are an important part of the mix in helping people quit smoking, Gottlieb rejected the flawed arguments made by anti-vaping crusaders that abstinence only approaches to nicotine are the only valid option for smokers or that e-cigarettes should be treated in the exact same way as regular cigarettes.
But it wasn't all good news. A deadline extension for product reviews is welcome, but unless there are significant changes to the process, the e-cigarette market could suffer a crippling of innovation and widespread destruction in 2022. Not knowing who might be president and leading the FDA at that time only adds to the uncertainty.
The FDA will also be looking hard at potentially restricting certain e-cigarette flavors that are alleged to appeal to kids. In fact, there is little evidence for this claim, but there is strong evidence suggesting e-cigarette flavors play a critical part in how adults give up smoking.
"We are concerned that Dr. Gottlieb may be going down the wrong path with his focus on flavors and reduced-nicotine cigarettes, we are going to celebrate today and get back to fighting bad policy tomorrow," said Conley.
The FDA also announced it would be opening up a dialogue about reducing nicotine levels in combustible cigarettes to non-addictive levels, so as to prevent young people from getting hooked on cigarettes. This policy has been discussed in tobacco control circles for some time but is deeply misguided for a host of reasons, ably explained by public health expert and tobacco harm reduction advocate Clive Bates.
If the FDA continues to look at the evidence calmly and rationally, ignoring the siren calls for product and flavor bans, Scott Gottlieb will leave the FDA with a proud legacy of reducing death and disease while fostering an environment of innovation, harm reduction, and consumer freedom. Friday's report is a good first step to securing that legacy, but there's a long way to go.
Guy Bentley (@gbentley1) is a contributor to the Washington Examiner's Beltway Confidential blog. He is a consumer freedom research associate at the Reason Foundation and was previously a reporter for the Daily Caller. Brian Fojtik (@PositiveEnerG) is a senior fellow at the Reason Foundation.
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