Since President Joe Biden signed legislation authorizing the agency to regulate tobacco products containing nicotine, the U.S. Food and Drug Administration (FDA) has sent more than 44 warning letters to manufacturers and over 300 to retailers, detailing violations related to non-tobacco nicotine (NTN) products from any source. In addition, the FDA has issued new warning letters to 102 retailers for illegally selling NTN products to minors.
In an update, the organization detailed "significant progress" in processing and reviewing applications for synthetic nicotine products for tobacco products prior to their release on the market.
On March 15, 2022, a new federal law granted the FDA the authority to regulate any tobacco products containing nicotine from any source. The law went into effect on April 14, 2022, and after July 13, 2022, any new Non-Traditional Tobacco (NTN) products that have not received prior authorization from the FDA cannot legally be sold.
The FDA has announced that it has received nearly one million new tobacco product applications from over 200 companies. According to the agency, all applications submitted before May 14th have been processed, and over 85% of them have been reviewed to determine if they meet the minimum requirements for further examination. The FDA has issued over 800,000 Refuse-to-Accept (RTA) letters for products that do not meet their standards.
The FDA has received more than 350 new tobacco product applications, the majority of which are for e-cigarettes or e-liquids. The agency emphasizes that acceptance does not determine the authorization status of the products. "Accepted applications will undergo further review to ensure they meet certain standards," the FDA wrote in its update.
For more information regarding the FDA's pre-market review progress, as well as compliance and enforcement actions, please visit the agency's NTN product webpage.
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