Tobacco Products

Cigarettes

The basic components of most cigarettes are tobacco, chemical additives, a filter, and paper wrapping. Smokers are exposed to a toxic mix of over 7,000 chemicals when they inhale cigarette smoke.1 The harmful chemicals in cigarette smoke can damage many parts of the body, including the heart and lungs or cause cancer. Nonsmokers are exposed to many of these same chemicals through secondhand smoke.

Statistics about Cigarette Use

  • Every day in 2014, on average, more than 2,600 youth under age 18 smoke their first cigarette and nearly 600 youth under age 18 become daily smokers.2
  • Nationwide in 2015, 9.3% (about 1.37 million) of high school students and 2.3% (an estimated 260,000) of middle school students reported smoking a cigarette in the past 30 days.3

FDA Regulation of Cigarettes

FDA regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of cigarettes, including components, parts, and accessories, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations.

Learn more about federal requirements limiting the sale, distribution, and marketing of cigarettes.


Manufacturing Cigarettes

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


Retail Sales of Cigarettes

If you sell cigarettes, 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.


Importing Cigarettes

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 have experienced 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. Substance Abuse and Mental Health Services Administration (SAMHSA). Results from the 2014 National Survey on Drug Use and Health: Detailed Tables. Rockville, MD: U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality; 2015. Table 4.10A. http://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs2014/NSDUH-DetTabs2014.pdf. Accessed September 11, 2015.
3. 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: 02/13/2017
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