On this page:
- FDA Regulation of Pipe Tobacco
- Manufacturing Pipe Tobacco
- Warning Statement Requirements
- Retail Sales of Pipe Tobacco
- Importing Pipe Tobacco
- Reporting Adverse Experiences and Product Violations
Pipe tobacco is generally loose leaf tobacco burned in a traditional smoking pipe with a bowl. Pipe tobacco is a combustible tobacco product.
Nationwide, 1.4 percent (an estimated 190,000) of high school students currently smoke pipes.1
In 2016, FDA finalized a rule extending our regulatory authority to cover all tobacco products, including pipe tobacco. FDA regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of pipe tobacco. This includes components and parts such as pipes, but excludes accessories such as lighters.
“Components” or “parts” include, among other things, software or an assembly of materials intended or reasonably expected to alter or affect the tobacco product’s performance, composition, constituents, or characteristics; or to be used with or for the human consumption of a tobacco product. Accessories of deemed tobacco products are not regulated. For a full definition of components, parts, and accessories, please read Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act.
If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import pipe tobacco, 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.
The United States District Court for the District of Columbia recently issued an order vacating the health warning requirements for cigars and pipe tobacco set forth in 21 CFR §§ 1143.3 and 1143.5 and remanding the Final Deeming Rule’s warning requirements for cigars and pipe tobacco back to the Agency. See Order, Cigar Ass’n of Am. v. U.S. Food & Drug Admin., No. 1:16-cv-01460 (D.D.C. September 11, 2020). Although the requirement has been vacated, cigar and pipe tobacco firms may choose to voluntarily comply with these health warning provisions. FDA will continue to enforce the other requirements it was already enforcing for cigars and pipe tobacco under the FD&C Act and its implementing regulations, such as not selling these products to individuals under 21 years of age or marketing them as modified risk tobacco products without an FDA order.
- Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco
- Required Warning Statements on Tobacco Product Packaging and Advertising.
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.
You can find a list of retailer responsibilities for pipe tobacco 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.
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.
- Small Business Assistance for Tobacco Product Industry
- Selling Tobacco Products in Retail Stores
1. Centers for Disease Control and Prevention (CDC). Tobacco use among middle and high school students – United States, 2011-2016. Morbidity and Mortality Weekly Report. 2017; 66(23):597-603.