FDA Updates Regulatory Documents to Include “Non-Tobacco Nicotine” Products

In response to the increase of non-tobacco nicotine in popular tobacco products, Congress passed a federal law that went into effect on April 14, 2022, granting 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, & Cosmetic Act to manufacturers, importers, retailers, and distributors of non-tobacco nicotine products. Previously, 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 FDA’s regulations and guidances has been considered to be amended since April 14, 2022. Today, FDA issued two notices in the Federal Register updating the definition of “tobacco product” in its existing regulations and guidances, and has also posted the following nine revised guidances to 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)
• Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Edition 3)

Efforts to make these updates are ongoing and additional revised guidance documents will be uploaded to the FDA website when available.