Tobacco Products

Hookah Tobacco (Shisha or Waterpipe Tobacco)

Hookah tobacco (also known as waterpipe tobacco, maassel, shisha, narghile, or argileh) 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. In fact, research shows that waterpipe smokers may absorb even more of the harmful chemicals found in cigarette smoke because smoking sessions are longer. A typical 1-hour hookah session involves inhaling 100–200 times the volume of smoke from a single cigarette. Waterpipe smokers are at risk for the same kinds of diseases caused by cigarette smoking.1

Statistics about Hookah (Waterpipe) Use

  • Nationwide, an estimated 700,000 high school students and 230,000 middle school students currently smoke waterpipe.2
  • In 2013-2014, 78.9% of youth aged 12-17 who smoked hookah said that they used hookah products because “they come in flavors I like.”3

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 now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of hookah tobacco. This includes components and parts of newly-regulated tobacco products but excludes accessories such as lighters, tongs, or external burners.

Image of a Hookah

 

“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 material
  • Bowls, valves, hoses, and heads

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


Retail Sales of Hookah (Waterpipe) 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 hookah 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 hookah 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 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 (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. Smoking & tobacco use: hookahs. CDC Fact Sheet. http://www.cdc.gov/tobacco/data_statistics/fact_sheets/tobacco_industry/hookahs/. 2013. Accessed August 18, 2014
2. 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.
3. Ambrose BK, Day HR, Rostron B et al. Flavored Tobacco Product Use Among U.S. Youth Aged 12‐17 Years, 2013‐2014,. Journal of the American Medical Association. 2015; 314(17):1871‐1873.


 

Page Last Updated: 08/18/2017
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