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On this page:

• Statistics about Hookah (Waterpipe) Use
• FDA Regulation of Hookah (Waterpipe) Tobacco
• Manufacturing Hookah (Waterpipe) Tobacco
• Nicotine Warning Statement
• Retail Sales of Hookah (Waterpipe) Tobacco
• Importing Hookah (Waterpipe) Tobacco
• Reporting Adverse Experiences and Product Violations

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Hookah tobacco (also known as waterpipe tobacco, maassel, shisha, narghile, or argileh) is a type of combustible tobacco that is smoked with a hookah (waterpipe).

Hookah (waterpipe) smoke exposes people to the addictive chemical nicotine and contains many of the same toxic chemicals that are in cigarette smoke.^{1, 2, 3, 4} In fact, research shows that waterpipe smokers may absorb even more of the harmful chemicals found in cigarette smoke because smoking sessions are typically longer. A typical one-hour hookah session involves inhaling 100–200 times the volume of smoke from a single cigarette.⁵

Waterpipe smokers are at risk for the same kind of diseases caused by cigarette smoking.^{6, 7, 8, 9} and may absorb even more toxic chemicals like carbon monoxide than cigarette smokers. ¹⁰ 

Statistics about Hookah (Waterpipe) Use

• Nationwide, an estimated 480,000 high school students and 150,000 middle school students currently smoke waterpipe.¹¹
• According to a 2013-2014 survey, 79 percent of youth aged 12-17 who smoked hookah said that they used hookah products because “they come in flavors I like."^12,13

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FDA Regulation of Hookah (Waterpipe) Tobacco

In 2016, FDA finalized a rule extending our regulatory authority to cover all tobacco products, including hookah tobacco. FDA regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of hookah tobacco. This includes components and parts of tobacco products regulated by the 2016 rule, but excludes accessories such as lighters, tongs, or external burners. 

“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. For more information about components, parts, and accessories, please read Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act. Examples of components and parts that are regulated include, but are not limited to:

• Hookah (waterpipe)
• Flavor enhancers
• Hose cooling attachments
• Water filtration base additives (including those that are flavored)
• Charcoal made from wood, coconut shell or other materials, as well as electric heating systems
• Bowls, valves, hoses, and heads

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Manufacturing Hookah (Waterpipe) Tobacco

If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import hookah (waterpipe) 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.

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Required Nicotine Addictiveness Warning on Packages and Advertisements

Beginning on August 10, 2018, all "covered" tobacco products* must bear the required nicotine addictiveness warning statement on product packages and advertisements. *Note: Cigars, which are also “covered” tobacco products, have additional required warning statements.  

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Retail Sales of Hookah (Waterpipe) Tobacco

You can find a list of retailer responsibilities for hookah (waterpipe) 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.

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Importing Hookah (Waterpipe) 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.

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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.

Additional Resources

• Small Business Assistance for Tobacco Product Industry 
• Manufacturing 
• Selling Tobacco Products in Retail Stores
• FDA's Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products

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