Is the FDA on the Brink of True Harm Reduction?

The U.S. Food and Drug Administration (FDA) has turned a page, but is it a bona fide harm reduction chapter?


‘Less is More’ Crusade
Big Tobacco is behind much of the widely publicized “less is more” innovation, and thus, is naturally backing up the new government directives. PMI submitted two applications to the FDA—a premarket tobacco product application for its iQOS and a modified-risk tobacco product (MRTP) application to market the device as a reduced-risk alternative—which, if approved, could pave the way for the product to be marketed and sold by Altria Group through a commercial agreement between the two companies.

What’s more, PMI, which recently registered the Foundation for a Smoke-Free World as a charitable U.S. organization, pledged up to $1 billion over the next 12 years to the nonprofit group for conducting scientific research on “how to best achieve a smoke-free world and advance the field of tobacco harm reduction.”

According to Reynolds American CEO Debra Crew, technological innovation presents the industry with an incredible opportunity to provide smokers their desired nicotine levels using less harmful alternatives to conventional cigarettes. In a recent CNBC report, Crew stated that the industry is ready to meet the challenge and expects to see increased innovation. She added that for progress to happen, the industry must work together with the government.

Even the vapor groups have something positive to say regarding Big Tobacco’s advancements—but with a plea that this be the start of an “opening up” to all tobacco harm reduction efforts.

In a submission to the FDA on Philip Morris Products S.A.’s MRTP for iQOS and Marlboro Heatsticks, American Vaping Association (AVA) President Gregory Conley called on the agency to grant the applications, saying adult smokers “deserve access to a wide variety of smoke-free nicotine and tobacco products.” He then added that the AVA’s only concern is that if this application is granted, adult smokers will be accurately informed that iQOS poses lower risks to users than smoking, but it “will remain a federal felony for manufacturers of vapor products, smokeless tobacco and smokeless nicotine products to truthfully inform consumers that their products do not contain smoke, let alone that they are less hazardous than smoking.”

Reasonable Doubt
Nevertheless, there is good reason to doubt that the government’s new nicotine reduction plan, as it is currently outlined, will work.


Wells Fargo is also betting the ultimate policy, after public and industry comment, will be a step in the right direction. “While still a mere supposition, even the FDA harbors the expectation that smoking-related disease and death would decrease ʻconsiderablyʼ under the right nicotine-reduction policy. If the FDA is serious about harm reduction and embracing a continuum-of-risk approach, we expect its final policy to ultimately be a positive for [reduced-risk product] consumption led by, in our view, iQOS.”

Story by Renée M. Covino

This story first appeared in the November/December 2017 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.