On this page:
- Statistics about Smokeless Tobacco Product Use
- FDA Regulation of Smokeless Tobacco Products
- Manufacturing Smokeless Tobacco Products
- Warning Statements and Warning Plans for Smokeless Tobacco
- Retail Sales of Smokeless Tobacco Products
- Importing Smokeless Tobacco Products
- Reporting Problems or Violations
Most smokeless tobacco use involves placing the product between the gum and the cheek or lip. Smokeless tobacco is a noncombustible tobacco product. There are two main types of smokeless tobacco that have been traditionally marketed in the United States: chewing tobacco and snuff, including snus.
- Chewing tobacco is cured tobacco in the form of loose leaf, plug, or twist.
- Dry snuff is loose finely cut or powdered dry tobacco that is typically sniffed through the nostrils.
- Moist snuff and snus are cut tobacco that can be loose or pouched and placed in the mouth. More than 30 chemicals in smokeless tobacco are linked to cancer1—smokeless tobacco causes cancers of the mouth, esophagus and pancreas.2
Some dissolvable tobacco products can be classified as smokeless tobacco products.
- Nationwide, 6% (an estimated 900,000) of high school students and 1.8% (an estimated 210,000) of middle school students were current users of smokeless tobacco in 2015.3
- Nationwide, 1.9% (an estimated 280,000) of high school students and 0.5% (an estimated 50,000) of middle school students were current users of snus in 2014.4
- Each day on average in 2014, about 1,300 youth under 18 years of age used smokeless tobacco for the first time.5
FDA regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of smokeless tobacco products, which includes products for use in the oral and nasal cavity, under the Comprehensive Smokeless Tobacco Health Education Act; the Federal Food, Drug, and Cosmetic Act (FD&C Act); and the FD&C Act’s implementing regulations.
On October 22, 2019, FDA granted the first-ever modified risk orders to Swedish Match USA, Inc. for eight snus smokeless tobacco products. This means the eight products may be advertised with specific information about the lower risks of certain health effects using the products compared to smoking cigarettes.
If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import smokeless tobacco, 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.
Learn more about required warning statements and warning plans for smokeless tobacco.
Note: On December 20, 2019, the President signed legislation to amend the Federal Food, Drug, and Cosmetic Act, and raise the federal minimum age of sale of tobacco products from 18 to 21 years. It is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21. FDA will provide additional details on this issue as they become available, and the information on this page will be updated accordingly in a timely manner.
If you sell smokeless tobacco, please read this summary of federal rules that retailers must follow. You may also order flyers with rules for smokeless tobacco sales or download them to print yourself.
Tobacco products imported or offered for import into the United States must comply with all the applicable requirements under the FD&C Act.
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.
If you have experienced an unexpected health or safety issue with a specific tobacco product, you can report a problem with any tobacco product 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.
- FDA Authorizes Modified Risk Tobacco Products
- Small Business Assistance for Tobacco Product Industry
- Selling Tobacco Products in Retail Stores
- Smokeless Tobacco Product Warning Labels
1. National Cancer Institute and Centers for Disease Control and Prevention. Smokeless Tobacco and Public Health: A Global Perspective. Bethesda, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Institutes of Health, National Cancer Institute. NIH Publication No. 14-7983; 2014.
2. Secretan, B., Straif, K., Baan, R., Grosse, Y., El Ghissassi, F., Bouvard, V., & Cogliano, V. A review of human carcinogens-Part E: tobacco, areca nut, alcohol, coal smoke, and salted fish. The Lancet Oncology. 2009;10(11): 1033-1034.
3. Centers for Disease Control and Prevention. Tobacco Use Among Middle and High School Students - United States, 2011-2015. Morbidity and Mortality Weekly Report 2016; 65(14): 361-367.
4. Centers for Disease Control and Prevention. Tobacco Product Use Among Middle and High School Students - United States, 2011-2014. Morbidity and Mortality Weekly Report 2015; 64: 381-5.
5. Substance Abuse and Mental Health Services Administration (SAMHSA). Results from the 2014 National Survey on Drug Use and Health: Detailed Tables. Rockville, MD: U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality; 2015. http://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs2014/NSDUH-DetTabs2014.pdf. Accessed September 11, 2015.