Details to Come on Implementation of Synthetic Nicotine Law

FDA says new provision addresses ‘critical need’ to clarify agency’s authority over these tobacco products
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SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) can soon regulate tobacco products containing nicotine from any source, including synthetic nicotine, after President Joe Biden signed the Consolidated Appropriations Act 2022.

Youth tobacco product use remains a public health concern, and millions of youth report use of electronic nicotine delivery systems (ENDS) products, including e-cigarettes, the FDA said in a Center for Tobacco Products (CTP) newsletter sent out after Biden signed the act.

“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,” the agency said. “That has been accomplished, ensuring products that are similar except for the source of nicotine will be regulated as tobacco products.”

The new provision takes effect on April 14, and manufacturers of tobacco products containing nicotine not derived from tobacco will need to submit a premarket tobacco product application (PMTA) to the FDA by May 14 to obtain authorization from the agency to market their product.

The FDA said it will provide additional information about the implementation of the new law and the PMTA process for synthetic nicotine products “in the near future.”

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