A Public Participation Forum for the FDA Center for Tobacco Products and its Federal Advisory Committee (TPSAC)

From: Convenience Store Decisions

After a meteoric rise in the market during the last few years, the future of e-cigarettes now rests with regulators, innovators.

By Howard Riell, Associate Editor

The U.S. Food and Drug Administration (FDA)’s deeming regulations on vapor products could shift the $3 billion that e-cigarettes/vape are estimated to generate this year in brick-and-mortar stores to online vendors and black market players.

Stakeholders have made the case that it’s important for the FDA to set a new predicate date in the final rule, and that Congress should update the predicate date for newly-deemed products. New FDA deeming regulations authorized earlier this year ban e-cigarette sales to Americans under age 18, among other stipulations.

From: The National Law Review

A class action failure-to-warn lawsuit against e-cigarette companies was thrown out by the Central District Court of California last week. The suit, filed by plaintiffs from CA, IL, and NY, included claims that the accused companies, including Lorillard Tobacco Co. and Reynolds American Inc. (which bought Lorillard in 2014), deceptively advertised the health benefits of e-cig products over traditional cigarettes.

From: Motley Fool

From: CSPDailyNews.com

All categories will be affected, but vapor dealt biggest blow, new study reveals

ATLANTA — The FDA’s new “deeming” rules will have an impact on all tobacco categories in terms of item range and unit volume, but vaping will take the biggest hit, according to a study released at last month’s NACS Show.

Most vaping products on the market today came out after the U.S. Food and Drug Administration’s designated “predicate” release date, which means that any product put onto the market after Feb. 15, 2007, would have to undergo an onerous application and review process to stay in stores.

From: R Street

by Brad Rodu, Tobacco Truth

A feature of this month’s annual meeting of the Smoke-Free Alternatives Trade Association (SFATA) was a videotaped interview with Mitch Zeller, director of the Food and Drug Administration’s Center for Tobacco Products. Following the video, I participated in a panel discussion of Zeller’s statements about e-cigarettes.

Mr. Zeller clearly implied that there was no population-level evidence that smokers had quit with e-cigarettes. He said the FDA is:

…absolutely aware of the anecdotal reports about individuals using e-cigarettes to help them quit, but we can’t make population-level policy on the basis of anecdotal reports … FDA is required to use a population health standard.