Tobacco Products

Nicotine Gels

A nicotine gel is a tobacco product that contains nicotine and can be absorbed through the skin.

Nicotine Hand Gel

Picture of Nicotine Hand Gel

FDA Regulation of Nicotine Gels

In 2016, FDA finalized a rule extending our regulatory authority to cover all tobacco products, including nicotine gels. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of nicotine gels. This includes components and parts of newly-regulated tobacco products but excludes accessories.

However, if nicotine gels are marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking), they are regulated by the FDA through the Center for Drug Evaluation and Research (CDER) as a drug. FDA recently proposed a rule clarifying the jurisdiction over tobacco products, drugs, and devices.


Manufacturing Nicotine Gels

If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import nicotine gels, you must comply with these requirements for manufacturers.

CTP’s Office of Small Business Assistance can answer specific questions about requirements of small businesses and how to comply with the law. This office also provides online educational resources to help regulated industry understand FDA regulations and policies.


Nicotine Warning Statement

Beginning in 2018, the product packages and advertisements of all newly-regulated covered tobacco products must bear the following warning statement:
 

“WARNING: This product contains nicotine. Nicotine is an addictive chemical.”


 If the tobacco product manufacturer submits a self-certification statement to FDA that the newly-regulated tobacco product does not contain nicotine (and that the manufacturer has data to support this assertion), then an alternate statement must be used on product packages and advertisements:
 

 “This product is made from tobacco.”


You can find more information about nicotine warning statements in Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act. 


Retail Sales of Nicotine Gels

If you sell nicotine gels, please read this summary of federal rules that retailers must follow.

You can find a list of retailer responsibilities for nicotine gels in Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act. In addition, our website offers a summary of regulations, guidance and webinars for retailers.


Importing Nicotine Gels

Tobacco products imported or offered for import into the United States must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). You can find more information on the Importing and Exporting webpage.

You can also learn more about the importation process in the FDA Regulatory Procedures Manual, Chapter 9, Import Operations and Actions.

If you have questions about importing a specific tobacco product, please contact the FDA district into which your product will be imported (PDF - 406 KB).


Reporting Adverse Experiences and Product Violations

If you have experienced an unexpected health or safety issue with a specific tobacco product, you can report your adverse experience to FDA. Knowledge about adverse experiences can help FDA identify health or safety issues beyond those normally associated with product use.

If you believe these products are being sold to minors, or you see another potential violation of the FD&C Act or FDA’s tobacco regulations, report the potential violation.

Page Last Updated: 11/07/2016
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