The FDA seems dead set on restricting the vapor industry very soon. The agency gave JUUL Labs and the four major tobacco companies that also sell vapor products 60 days to submit plans to eliminate sales to teenagers. That 60-day deadline expires soon after next week’s elections.
Now a group of influential academics and tobacco control and public health experts is trying to convince the agency to slow down and consider the risks of hasty regulation. The National Tobacco Reform Initiative (NTRI) has sent a letter to Scott Gottlieb, calling on the FDA commissioner to hold a summit of stakeholders to discuss FDA’s policy on vapor products and vaping.
“To fully address the situation will require the involvement and support of not only FDA, but other stakeholders as well,” NTRI coordinator Allan Erickson wrote to Gottlieb. Erickson is a former American Cancer Society vice president, who now thinks e-cigarettes can play a part in tobacco control efforts to reduce smoking.
“We therefore wish to recommend that the FDA/CTP sponsor a national dialogue related to youth use of tobacco and nicotine products as well as the need to provide the 30 million adult smokers in this country with lower risk alternative tobacco and nicotine products, to be held sometime in early 2019,” wrote Erickson.
Of course, whether the FDA has any real interest in balancing those goals is questionable. Gottlieb has already said that eliminating youth use will likely require restricting adult choices. He has specifically mentioned eliminating non-tobacco flavors and online sales as likely targets for the agency. The FDA is already in the process of creating rules for e-liquid flavors.
The low-key National Tobacco Reform Initiative is mostly made up of respected people from tobacco control and academia who advocate for vaping (and other low-risk nicotine products like snus) to play a role in reducing the damage caused by combustible cigarettes. NTRI seems to recognize that tobacco control has lost its way and abandoned its core mission.
The NTRI leadership includes David Abrams and Ray Niaura of New York University (and both formerly with the Truth Initiative), former American Heart Association vice president Scott Ballin, and former American Cancer Society president John Seffrin. The organization’s advisory group includes Clive Bates and Iowa Attorney General Tom Miller. Miller was one of the state attorneys general who sued the tobacco companies, leading to the 1998 Master Settlement Agreement. He was also chair of the Truth Initiative board until last year.
NTRI sent Gottlieb a letter earlier this year questioning whether the FDA’s research agenda and education campaigns aligned with Gottlieb’s stated goal to regulate tobacco and nicotine products based on a continuum of risk. Since then, instead of finally beginning to communicate the truth about nicotine, the agency has launched a $60 million anti-vaping propaganda blitz.
The new letter to Gottlieb refers to the previous one, and asks that the agency not put the lives of smokers second to fear of a youth “epidemic” when crafting regulations.
“In our letter to you this past July, we raised concerns that this second priority is seemingly taking a back seat as the agency shifted resources to dealing with the e‐cigarette and adolescent issue,” says the new communication to FDA Commissioner Gottlieb. “We believe that the issue of youth use of e‐cigarettes as well as addressing the needs of the 30 million smokers can and should go forward in tandem.”
The FDA appears to be hell bent on doing something to make itself look decisive to the crusading tobacco control activists who are driving the JUUL moral panic, and the politicians demanding a flavor ban. Last week, tobacco giant Altria voluntarily removed most of its flavored products from the market in a cynical ploy to please the FDA and pressure JUUL into slowing its sales juggernaut by eliminating its own flavors. JUUL is crushing Altria’s vapor products in the convenience store market, and even cutting into its cigarette sales.
The NTRI letter may be too late to affect Gottlieb’s thinking. He’s shown no signs of cooling his reckless “epidemic” rhetoric. There’s nothing the FDA commissioner needs more now than wisdom from clear-headed and open-minded veterans of the tobacco wars. But he appears less and less likely to listen.