Additional Tobacco Companies File PMTAs for Regulatory Review – CSNews Online

Additional Tobacco Companies File PMTAs for Regulatory Review – CSNews Online

NATIONAL REPORT — Time is up for tobacco companies to file premarket tobacco applications (PMTAs) for the majority of newly deemed tobacco products with the Food and Drug Administration (FDA).

Now that the Sept. 9 deadline has passed, convenience store retailers are finding out which companies have submitted PMTAs and can remain on the backbar pending final FDA review.

Under the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA must approve PMTAs for newly deemed tobacco products — including electronic cigarettes and vapor products — to remain on the market.

In summer 2019, District Judge Paul Grimm of the U.S. District Court for the District of Maryland set a May 12, 2020 deadline for companies to submit their applications to the agency. However, this April, Grimm agreed to extend the deadline to Sept. 9, 2020 as tobacco companies and the FDA weather the challenges of the COVID-19 pandemic. 

In early September, the FDA said it will publish a list of those products with submissions on file. Without a listing from the FDA, retailers would have to rely on their suppliers, wholesalers and distributors to inform them which products are no longer available — a concern that drew retailer groups, including NACS, to urge the agency to provide an account of the PMTAs.

In addition to several PMTAs previously detailed by Convenience Store News, the following companies have filed applications with the agency:

Bidi Vapor LLC

Bidi Vapor LLC filed a PMTA for its family of disposable e-cigarette products under the Bidi Stick brand name. The Melbourne, Fla.-based company’s application detailed 11
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