Tobacco Products

Pipe Tobacco

Pipe tobacco is generally loose leaf tobacco used in a traditional smoking pipe with a bowl.

Nationwide, 1% (an estimated 150,000) of high school students currently smoke pipes.1

FDA Regulation of Pipe Tobacco

In 2016, FDA finalized a rule extending our regulatory authority to cover all tobacco products, including pipe tobacco. FDA now 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.

Pipe Tobacco

Image of Pipes and Pipe Tobacco

Click for larger version

“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 newly-regulated 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.


Manufacturing Pipe Tobacco

If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import pipe 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.


Nicotine Warning Statement

Beginning in 2018, the product packages and advertisements of all newly-regulated covered tobacco products 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 that assertion), then an alternate statement may be used on product packages and advertisements:
 

“This product is made from tobacco.”


 You can find more information about nicotine warning statements in Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act.  


Retail Sales of Pipe Tobacco

Federal Rules for Hookah and Pipe Tobacco Sales Flyer

Retail Rules for Hookah and Pipe Tobacco Sales flyer thumbnail.  Click to Access.

If you sell pipe tobacco, please read this summary of federal rules that retailers must follow.

You may also share the fact sheet below with your staff and post it in your store.

You can find a list of retailer responsibilities for pipe tobacco in Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act. Our website also offers a summary of regulations, guidance and webinars for retailers.


Importing Pipe Tobacco

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 (PDF - 406 KB).


Reporting Adverse Experiences and Product Violations

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. 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.


 

Page Last Updated: 05/17/2017
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