FDA Publishes Update to Include ‘Nontobacco Nicotine’

The U.S. Food and Drug Administration has updated its definition of “tobacco products” to include nontobacco nicotine products.

In response to the increase of nontobacco nicotine in popular tobacco products, Congress passed a federal law that went into effect on April 14, 2022, granting the FDA authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine. This new law extended the tobacco product requirements in the Federal Food, Drug and Cosmetic Act to manufacturers, importers, retailers and distributors of nontobacco nicotine products. Previously, the FDA’s tobacco product authority only extended to tobacco products that contain nicotine made or derived from tobacco.

Under this legislation, the definition of “tobacco product” in the FDA’s regulations and guidances has been considered to be amended since April 14, 2022. The FDA has now issued two notices in the Federal Register updating the definition of “tobacco product” in its existing regulations and guidances.

In addition, the agency has also posted the following nine revised guidances to the FDA’s website: Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers (Revised); Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order (Revised); Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products (Revised); Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug and Cosmetic Act Requirements to Vape Shops (Revised); Listing of Ingredients in Tobacco Products (Revised); Premarket Tobacco Product Applications for Electronic Nicotine-Delivery Systems (Revised); The Prohibition of Distributing Free Samples of Tobacco Products (Revised); FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements (Revised); and Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Edition 3).