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  1. Products, Ingredients & Components

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What Are Nicotine Gels?

Nicotine gel is a tobacco product that contains nicotine and is absorbed through the skin. Nicotine gel is a noncombustible tobacco product.

Picture of Nicotine Hand Gel

Are You Looking for General Health and Safety Information Related to Nicotine Gel Products?

To protect people in the United States from tobacco-related disease and death, FDA provides information about tobacco products, including nicotine gel products, and the dangers they pose to the public.

Tobacco contains thousands of chemicals. This mix of chemicals—not nicotine—is what causes serious disease and death. However, nicotine is why tobacco products are addictive.

Health Effects of Tobacco Use

No tobacco product is considered safe. Using any tobacco product —including nicotine gel tobacco products—can harm your health. Different tobacco products, however, pose varying levels of health risk.

Resources in the FDA Tobacco Education Resource Library

Learn more about print materials, web content, and social media posts available for free that help keep communities informed about tobacco-related issues.

See Tobacco Product Resources

Report a Tobacco Product Problem or Violation

If you have experienced undesired health or quality problems with any tobacco product, including nicotine gel tobacco, you can report it to FDA. Knowing more about adverse experiences can help FDA identify concerning trends and causes or contributors for particular incidents or health or quality problems beyond those normally associated with tobacco product use. You can read some tobacco-related adverse experience reports on the Tobacco Product Problem Reports page.

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

Are You a Manufacturer of Nicotine Gel Products?

FDA regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of nicotine gel products under the FD&C Act and its implementing regulations. This includes components and parts but excludes accessories.

However, if nicotine gel products 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 when products made or derived from tobacco are regulated as tobacco products, drugs, and/or devices.

If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import any tobacco product, then you are considered a tobacco product manufacturer. Importers of finished tobacco products are regulated as tobacco product manufacturers, distributors, or both. If you are a tobacco product manufacturer, find out more information on complying with FDA’s tobacco products regulation on CTP’s Manufacturing webpage.

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.

Are You a Retailer of Nicotine Gel Products?

This is Our Watch

Tools for Retailers

This is Our Watch” is an education program with resources to help tobacco retailers better understand and comply with FDA tobacco regulations. Tobacco retailers play a direct role in protecting kids from nicotine addiction and the deadly effects of tobacco use. Learn what tobacco retailers need to do to comply with the rules designed to prevent our nation's youth from becoming the next generation of people to die prematurely from tobacco-related disease.

Retail Sales of Tobacco Products offers more information about federal rules that retailers must follow as well as information on regulations, guidance, and tools to help retailers comply.

Did You Know?

It is illegal for a retailer to sell any tobacco product – including cigarettes, cigars, smokeless tobacco, and e-cigarettes – to anyone under 21.


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