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FDA PMTA (CVS Receipt Long) List

FDA PMTA (CVS Receipt Long) List

Disposable vapes have had a stronghold on the market since the introduction of flavors. But now there have been new laws implemented by the FDA that regulate what products are allowed to remain on the market.

During the one-year grace period for products listed on the market before August 8, 2016, and for which a premarket tobacco application (PTMA) was submitted by September 9, 2020.

The list in its entirety includes more than six million individual product SKUs submitted by hundreds of companies. The list also contains products that are currently being sold and do not include flavored cartridges and pod-based products that the agency forced off the market as part of its January 2020 updated enforcement guidance.

The list was demanded by anti-vaping tobacco crusaders, and also by business associations representing retailers that sell vaping products. Any product not on the list is deemed non-compliant with FDA rules which makes it illegal to sell.

(A short snapshot of the six million products)

The list is most efficient for cross-referencing submitted products by the FDA product registration database, which allows the agency to easily investigate whether the manufacturers of products being sold online have submitted PMTAs. A cumbersome task, but that's how the agency has begun issuing warning letters to small manufacturers for selling non-compliant products.

The FDA reports that the list is not complete. Companies that didn’t provide their information in time to make the first iteration of the list are not included. Also, some of the same products sold under a different name are not required to be listed separately.

What this list means is that the products listed meet the basic requirements for submitting a PMTA and will be allowed to remain on the market until Sept. 9, 2021, unless their application is rejected at such time.

The FDA is prevented by a court order from issuing a blanket extension for all products that haven't been fully reviewed. However, there are grant extensions, varying each case. If you're a wholesaler of tobacco products, it would behoove you to take a gander at the list in its entirety.

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