On this page:
- FDA Regulation of Roll-Your-Own Tobacco Products
- Manufacturing Roll-Your-Own Tobacco Products
- Required Warning Statements
- Retail Sales of Roll-Your-Own Tobacco Products
- Importing Roll-Your-Own Tobacco Products
- Reporting Adverse Experiences and Product Violations
Roll-your-own tobacco is loose tobacco that the user places inside rolling paper and burns. It is a combustible tobacco product.
Roll-your-own tobacco products are not safer than other types of cigarettes. Just like with other types of cigarettes, the user burns the tobacco and inhales harmful chemicals. Tobacco smoke contains a toxic mix of over 7,000 chemicals.1 The harmful chemicals in tobacco smoke can damage nearly every organ in the body.2 Nonsmokers are exposed to many of these same chemicals through secondhand smoke.
FDA regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of roll-your-own tobacco and cigarette tobacco under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. FDA also regulates the tobacco rolling paper.
If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import roll-your-own 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.
Beginning in 2018, all product packages and advertisements for cigarette tobacco and roll-your-own tobacco 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 such assertion), then an alternate statement must be used on product packages and advertisements:
“This product is made from tobacco.”
You can find more information on required warning statements in Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act.
If you sell roll-your-own tobacco, please read this summary of federal rules that retailers must follow. In addition, our website provides more information on regulations, guidance and webinars for retailers.
Click on the flyer thumbnail image to order printed materials from CTP's Exchange Lab or to download a PDF to print yourself.
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.
If you experience 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.
1. U.S. Department of Health and Human Services (USDHHS). A Report of the Surgeon General: How Tobacco Smoke Causes Disease: What It Means to You (Consumer Booklet). Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2010.
2. U.S. Department of Health and Human Services (USDHHS). How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2010.