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April 22, 2022

FDA Synthetic Nicotine Loophole Closes

On April 11, a new federal law took effect allowing FDA to regulate the full range of vaping products. The provisions were included in the Consolidated Appropriations Act 2022 and amended the definition of tobacco product in the Family Smoking Prevention and Tobacco Control Act to include products containing nicotine from any source. Under the previous definition, vaping products that were not derived from tobacco fell outside FDA’s regulatory authority, and some companies had begun to manufacture synthetic nicotine that was not derived from tobacco in an effort to circumvent FDA’s regulatory authority. Under the new law, companies have until May 11 to file a Pre-Market Tobacco Application (PMTA) with FDA to keep their products on the market, and FDA must issue an authorization order by July 11 on PMTAs it receives.