FDA Rules Will Have Big Effect on OTP

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.

Presenting at an educational session at the NACS Show in Atlanta last month, Pittsburgh-based Management Science Associates (MSA) gathered data from wholesale deliveries through this past July and found that the FDA rules will possibly affect 30% of total items within the tobacco category, but only 8% of volume going through c-stores.

So the good news is that most c-store tobacco volume will go largely unaffected by the deeming regulations, said Don Burke, senior vice president of MSA, to an audience of more than 200 attendees. Unfortunately, 49% of cigar volume and 100% of vapor volume will fall under new FDA scrutiny.

To help combat the impact of the rules on vaping, NACS officials have begun a grassroots education effort using social media to reach out to c-store retailers and the vaping community.

Creating a website called, Lyle Beckwith, senior vice president of government relations for NACS, Alexandria, Va., is calling attention to current legislation—from the Cole-Bishop Amendment to the Agricultural Appropriations Bill—that could move the 2007 grandfather date to sometime in 2016, which would keep many products already on the market from having to go through the arduous application process.

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