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September 2, 2021
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FDA Still Sending Warning Letters to "PMTA Dodgers"

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Jim McDonald

Although overshadowed by the FDA’s decision to deny Premarket Tobacco Applications (PMTAs) that don’t include “product-specific” evidence addressing flavored vaping products’ “risk posed to youth,” the agency is continuing its purge of products sold by small vape manufacturers without first submitting PMTAs.

Products that were not submitted for review by the Sept. 9, 2020 deadline were supposed to have been removed immediately from the market. The difficult and expensive PMTA process discouraged many small manufacturers from attempting to comply, and many continued to sell products after the deadline.

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The FDA Center for Tobacco Products announced Thursday that 29 warning letters were sent in August to vaping manufacturers and sellers, ordering them to remove products from the market or face enforcement actions. According to the agency, these companies have more than 268,000 products registered with the FDA.

Two of the letters sent in August went to manufacturers that submitted PMTAs the FDA refused to accept, and another went to a company that filed PMTAs for some products but not others.

Since our last update on June 4, the FDA has issued 47 warning letters (including the August letters), making a total of 169 so far this year.

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Jim McDonald

Vaping since: 12 years

Favorite products:

Favorite flavors: RY4-style tobaccos, fruits

Expertise in: Political and legal challenges, tobacco control haters, moral panics

Jim McDonald

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I’m a member of the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy

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