FDA Passes Federal Law to Regulate Non-Tobacco Nicotine Products

According to an article released by the FDA on March 17th, the U.S. Congress has passed a federal law effective on April 14th, 2022 in response to the increase of non-tobacco nicotine in e-cigarettes. On March 17th, the FDA released two notices in the Federal Register, updating the definition of "tobacco products" in their existing regulations and guidelines.

The law will grant FDA the authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine. This new law expands the requirements for tobacco products in the Federal Food, Drug, and Cosmetic Act to manufacturers, importers, retailers, and distributors of non-tobacco nicotine products. Previously, FDA's authority to regulate tobacco products was limited to those containing nicotine made or derived from tobacco.

According to this legislation, as of April 14, 2022, the definition of "tobacco products" in the regulations and guidelines of the FDA is considered revised. The FDA website has released nine revised guidelines in accordance with this revision.

The revised civil penalties and tobacco sales ban for tobacco retailers have established a deadline for complying with the ban. The revised regulations also include provisions from the Food and Drug Administration (FDA) to extend its general regulations to cover tobacco products. Compliance policies and explanations for certain labeling requirements have also been added. Additionally, certain federal laws related to food, drugs, and cosmetics have been updated to apply to electronic cigarette stores. Ingredients must be listed for all tobacco products, and the FDA has implemented a pre-market tobacco product application process for electronic nicotine delivery systems (ENDS). The distribution of free tobacco samples is now prohibited. The FDA has established authority over certain tobacco products and has imposed sales and distribution restrictions, as well as health warning requirements, on packaging and advertising. Common questions concerning the substantial equivalence of new tobacco products are answered in the third edition of the FAQ.

According to reports, non-tobacco nicotine refers to nicotine contained in substances other than tobacco, such as synthetic nicotine or nicotine extracted from plants. In some cases, non-tobacco nicotine may be used to produce products such as electronic cigarettes and tobacco heating non-combustible products as alternatives to traditional tobacco products.

Reference:

The Food and Drug Administration (FDA) has revised its regulatory documents to encompass "non-tobacco nicotine" items.

According to the definition of the term "tobacco products" as outlined in the guidelines published under the Federal Food, Drug, and Cosmetic Act (original text).

FDA Guidance Document (Original Text)