Will Vaping Replace Cigarettes?
On Friday, Scott Gottlieb the head of the Food and Drug Administration made a huge announcement. Gottlieb and the FDA are extending the deadline for PMTA’s to Aug. 8, 2022, giving much-needed breathing space to the thousands of businesses that would have had to close next year.
According to Oliver Kershaw,”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.
Unveiling a comprehensive plan for tobacco and nicotine regulation, Gottlieb gave producers and vapers a lifeline.
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.”
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.
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.”