FDA Include Non-Tobacco Nicotine Products in Updated Regulatory Documents

Regulations
Mar.23.2023
The U.S. Congress passed a law regulating non-tobacco nicotine products by the FDA. FDA also updated the definition of "tobacco product" in its existing regulations and guidance in the Federal Register.
FDA Include Non-Tobacco Nicotine Products in Updated Regulatory Documents

 

According to an article published by the FDA on March 17, in response to the increase in non-tobacco nicotine in popular tobacco products, the U.S. Congress passed a federal law that will take effect on April 14, 2022. As a result, the FDA also updated the definition of "tobacco product" in its existing regulations and guidance in the Federal Register.

 

The law would allow the FDA to regulate tobacco products containing nicotine from any source, including synthetic nicotine. Previously, FDA's tobacco product regulatory authority was limited to tobacco products containing nicotine manufactured or extracted from tobacco. The new law extends the tobacco product requirements of the Federal Food, Drug, and Cosmetic Act to manufacturers, importers, retailers, and distributors of non-tobacco nicotine products. 

 

Following this legislation, the definition of "tobacco product" in FDA's regulations and guidance is considered to be amended on April 14, 2022, and the following nine revised guidance are published on 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 Requirements; 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)

 

It is reported that non-tobacco nicotine refers to the nicotine contained in substances other than tobacco (such as synthetic nicotine, nicotine extracted from plants, etc.). In some cases, non-tobacco nicotine may be used to produce e-cigarettes, tobacco heat-not-burn products, and other products that replace traditional tobacco products.

 

 Reference:

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

Definition of the Term “Tobacco Product” in Guidances Issued Under the Federal Food, Drug, and Cosmetic Act

Guidance

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