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New Law Clarifies FDA Authority to Regulate Synthetic Nicotine

March 18, 2022

On March 15, 2022, President Biden signed H.R. 2471 – the Consolidated Appropriations Act, 2022. As a result, the Federal Food, Drug, and Cosmetic Act (FD&C Act) now includes specific language that makes clear the U.S. Food and Drug Administration can soon regulate tobacco products containing nicotine from any source, which includes synthetic nicotine.

Youth tobacco product use remains a serious public health concern, and millions of American youth report use of electronic nicotine delivery systems (ENDS) products, including e-cigarettes.

Reports of e-cigarette manufacturers switching to nicotine not derived from tobacco in an attempt to evade FDA regulation revealed a critical need to clarify FDA’s authority over these products.  That has been accomplished, ensuring products that are similar except for the source of nicotine will be regulated as tobacco products.

This new provision of the law takes effect on April 14, 2022. Manufacturers of tobacco products containing nicotine not derived from tobacco will soon need to submit a premarket tobacco product application (PMTA) to the FDA and obtain authorization from the Agency to market their product under the FD&C Act as amended by this legislation, or they will be subject to FDA enforcement.

The FDA will provide additional information about the implementation of this new law and the PMTA process for these types of products in the near future.

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