On this page:
- FDA Regulation of Nicotine Gels
- Manufacturing Nicotine Gels
- Nicotine Warning Statement
- Retail Sales of Nicotine Gels
- Importing Nicotine Gels
- Reporting Adverse Experiences and Product Violations
A nicotine gel is a tobacco product that contains nicotine and can be absorbed through the skin. Nicotine gel is a noncombustible tobacco product.
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 regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of nicotine gels. This includes components and parts of newly-regulated tobacco products regulated by the 2016 rule, 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 FDA through the Center for Drug Evaluation and Research (CDER) as a drug. In 2017, FDA published 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 the 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.
Required Nicotine Addictiveness Warning on Packages and Advertisements
Beginning in 2018, all "covered" tobacco products must bear the required nicotine addictiveness warning statement on product packages and advertisements. Note: Cigars , which are also “covered” tobacco products, have additional required warning statements.
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 the final rule Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act. In addition, our website offers more information on 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.
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.