During the first quarter of 2021, the FDA issued 166 warning letters to tobacco products.
The United States Food and Drug Administration issued a total of 166 warning letters to the industry. Tobacco Reporter and Vapor Voice analysis found that 46 percent of warning letters sent during the first quarter were issued to e-cigarette and e-liquid manufacturers. It also turns out that the vast majority of the products at issue violated the terms of the FDA’s premarket tobacco approval product currently on sale in the U.S.
According to Law360 analyst Katie Insogna, virtually every warning letter for a tobacco product was issued during the period under consideration. The Food and Drug Administration (FDA) cited the manufacturer because their e-liquid products were also considered new tobacco products and even lacked the submission of a premarket tobacco product application. Thus, these products aren’t subject to an exemption from the PMTA rule.
Federal law mandates that every single tobacco product sold in the United States should be labeled and regulated in accordance with the Tobacco Control Act of 2009. In many of the recent warning letters, notes the Reporter, “the agency acknowledges that the recipient is a registered manufacturer with thousands of products already listed with the FDA.” As is the standard case for the FDA’s warning letters, the food and tobacco regulator typically provides 15 ‘working days’ for companies to respond and act. If a company fails to address any violations, the firms could be punished by actions and sanctions that include civil penalties, seizure, and an injunction preventing operations.
Many of the warning letters are also centered around COVID-19 related products that make false claims. Companies, especially marketing such products as tobacco and vapes, are likely to receive “exceptional regulatory scrutiny.”
“Companies marketing products in both of these categories should be particularly cautious of applicable federal regulations, to avoid negative action,” notes the analysis.
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