March 1, 2021

Volume XI, Number 60

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February 26, 2021

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FDA Issues Warning Letters to Vape Companies that Did Not Submit Premarket Tobacco Product Applications (PMTAs)

On January 15, 2021, the U.S. Food and Drug Administration (FDA) issued warning letters to ten companies that sell electronic nicotine delivery system (ENDS) products, including e-liquids.  FDA’s letters warned that any new tobacco product not in compliance with the premarket authorization requirements of the Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, is adulterated and misbranded, and may not be marketed without FDA authorization.

By way of background, the premarket tobacco product application (PMTA) process ensures that new tobacco products will undergo a scientific evaluation by FDA to ensure that such products are appropriate for the protection of the public health.  Certain new tobacco products (g., ENDS on the market as of August 8, 2016, the effective date of FDA’s “Deeming Rule”) were required to complete and submit PMTAs by September 9, 2020 – a deadline established as a result of a federal district court order.  In compliance with that court’s order, FDA stated that companies that submitted applications by the deadline are allowed to continue selling those products for up to a year (i.e., until September 9, 2021), unless FDA rejects the PMTA filing, or uses its enforcement discretion to allow products sufficiently far along in the review process to remain on the market on a case-by-case basis. On January 19, 2021, four months after the submission deadline, FDA finalized its long-awaited “foundational rule” on PMTAs.

FDA also emphasized that it would continue to prioritize enforcement against companies that have not submitted a PMTA and that market ENDS, including e-cigarettes and products with a likelihood of youth use or initiation (g., cartridge or pod-based ENDS).

FDA requested that each company respond within 15 days of receiving the letter detailing how it will address FDA’s concerns, including the dates on which the company discontinued the sale and/or distribution of the tobacco products, and its plans for maintaining compliance.  FDA stated that the failure to address violations may result in a civil money penalty, seizure, and/or injunction.

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© 2020 Keller and Heckman LLPNational Law Review, Volume XI, Number 21
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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