Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Products, Ingredients & Components

Products, Ingredients & Components

                        Cigarettes
          Chemicals in Cigarettes: From Plant to Product to Puff
          Cigars, Cigarillos, Little Filtered Cigars
          Dissolvable Tobacco Products
          E-Cigarettes, Vapes, and other Electronic Nicotine Delivery Systems (ENDS)
          Menthol and Other Flavors in Tobacco Products
          Harmful and Potentially Harmful Constituents (HPHCs)
          Hookah Tobacco (Shisha or Waterpipe Tobacco)
          Nicotine Gels
          Regulation and Enforcement of Non-Tobacco Nicotine (NTN) Products
          Roll-Your-Own Tobacco
          Pipe Tobacco
          Smokeless Tobacco Products, Including Dip, Snuff, Snus, and Chewing Tobacco Home
          Tobacco Products
          Products, Guidance & Regulations
          Products, Ingredients & Components
          Nicotine GelsProducts, Ingredients & Components Nicotine Gels
  
  	
    Share
    Post
    Linkedin

    Email
    Print**On this page:**

What Are Nicotine Gel Products?
	Are You Looking for General Health and Safety Information Related to Nicotine Gel Products?
	Health Effects
		Resources in the FDA Tobacco Education Resource Library
		Report a Tobacco Product Problem or Violation
	Are You a Manufacturer of Nicotine Gel Products?
	Are You a Retailer of Nicotine Gel Products?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 the public health of the U.S. population from tobacco-related death and disease, 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.

                                                                                  Content current as of:
      08/22/2023Products, Ingredients & Components

          
                        Cigarettes
          Chemicals in Cigarettes: From Plant to Product to Puff
          Cigars, Cigarillos, Little Filtered Cigars
          Dissolvable Tobacco Products
          E-Cigarettes, Vapes, and other Electronic Nicotine Delivery Systems (ENDS)
          Menthol and Other Flavors in Tobacco Products
          Harmful and Potentially Harmful Constituents (HPHCs)
          Hookah Tobacco (Shisha or Waterpipe Tobacco)
          Nicotine Gels
          Non-Tobacco Nicotine (NTN) Products
          Roll-Your-Own Tobacco
          Pipe Tobacco
          Smokeless Tobacco Products, Including Dip, Snuff, Snus, and Chewing Tobacco
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop