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Cigarettes | FDA
Cigarettes
On this page:
Statistics about Cigarette Use
FDA Regulation of Cigarettes
Manufacturing Cigarettes
Retail Sales of Cigarettes
Importing Cigarettes
Reporting Adverse Experiences and Product Violations
The basic components of most cigarettes are tobacco, chemical additives, a filter, and paper
wrapping. Cigarettes are responsible for the vast majority of all tobacco-related disease and
death in the United States. Smokers are exposed to a toxic mix of over 7,000 chemicals when
they inhale cigarette smoke.1 The harmful chemicals in cigarette smoke (/tobaccoproducts/products-ingredients-components/harmful-and-potentially-harmful-constituentshphcs) can damage nearly every organ in the body.2 Nonsmokers are exposed to many of these
same chemicals through secondhand smoke.
Chemicals in Cigarettes:
From Plant to Product to Puff (/tobacco-products/products-ingredientscomponents/chemicals-cigarettes-plant-product-puff)
https://www.fda.gov/tobacco-products/products-ingredients-components/cigarettes
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How a Cigarette Is Engineered (/tobacco-products/products-ingredientscomponents/how-cigarette-engineered)
Order free FDA posters on the health consequences of tobacco use (/tobaccoproducts/health-information/public-health-resources-tobacco-controlprofessionals#order)
https://www.fda.gov/tobacco-products/products-ingredients-components/cigarettes
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Statistics about Cigarette Use
Every day, on average, about 2,000 youth under age 18 smoke their first cigarette and
more than 300 youth under age 18 become daily smokers.3
Nationwide, 7.6 percent of high school students (1.2 million) and 2.1 percent of middle
school students (250,000) currently smoke cigarettes.4
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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 (/tobacco-products/retail/retailer-regulations-and-guidance).
In July 2017, the FDA announced a comprehensive plan for tobacco and nicotine regulation
(/tobacco-products/newsroom/fdas-comprehensive-plan-tobacco-and-nicotine-regulation) that
will serve as a multi-year roadmap to better protect kids and significantly reduce tobaccorelated disease and death, including pursuing lowering nicotine in cigarettes to non-addictive
levels.
https://www.fda.gov/tobacco-products/products-ingredients-components/cigarettes
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“Heated tobacco products” and “heat-not-burn tobacco products” are colloquial terms that do
not appear to have universally agreed upon definitions and seem to be used interchangeably.
For the FDA’s purposes, if a tobacco product meets the legal definition of a cigarette but the
tobacco is not heated to a temperature high enough to cause combustion, the product would be
currently categorized as a “non-combusted cigarette” and regulated as a cigarette.
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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
(/manufacturing-0).
CTP’s Office of Small Business Assistance (/tobacco-products/compliance-enforcementtraining/small-business-assistance-tobacco-product-industry) 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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Retail Sales of Cigarettes
If you sell cigarettes, please read this summary of federal rules that retailers must follow
(/tobacco-products/retail/summary-federal-rules-tobacco-retailers). In addition, our website
provides more information on regulations, guidance and webinars for retailers (/tobaccoproducts/retail/retailer-regulations-and-guidance).
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.
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 (/tobacco-products/products-guidancehttps://www.fda.gov/tobacco-products/products-ingredients-components/cigarettes
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regulations/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 (/media/75281/download).
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 (/tobacco-products/science-research/safetyreporting-portal-tobacco-products). 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 (/tobaccoproducts/compliance-enforcement-training/report-potential-tobacco-product-violation).
References
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. U.S. Department of Health and Human Services (USDHHS). How Tobacco Smoke Causes Disease: The Biology and
Behavioral Basis for Smoking-Attributable Disease: A Report of the Surgeon General. 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.
3. Substance Abuse and Mental Health Services Administration (SAMHSA). 2017 National Survey on Drug Use and
Health: Detailed Tables. Rockville, MD: U.S. Department of Health and Human Services, SAMHSA, Center for Behavioral
Health Statistics and Quality; 2018. https://www.samhsa.gov/data/sites/default/files/cbhsqreports/NSDUHDetailedTabs2017/NSDUHDetailedTabs2017.pdf. Accessed October 12, 2018. (Original Data Source:
NSDUH 2017, Table 4.10A)
4. Wang TW, Gentzke A, Sharapova S, et al. Tobacco Product Use Among Middle and High School Students – United
States, 2011-2017. MMWR Morb Mortal Wkly Rep. 2018; 67:629–33.
https://www.fda.gov/tobacco-products/products-ingredients-components/cigarettes
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Additional Resources
Cigarette Labeling and Health Warning Requirements (/tobacco-products/labeling-andwarning-statements-tobacco-products/cigarette-labeling-and-health-warningrequirements)
Chemicals in Cigarettes: From Plant to Product to Puff (/tobacco-products/productsingredients-components/chemicals-cigarettes-plant-product-puff)
How Cigarettes Are Made and How You Can Make a Plan to Quit (/tobaccoproducts/products-ingredients-components/how-cigarettes-are-made-and-how-you-canmake-plan-quit)
Small Business Assistance for Tobacco Product Industry (/industry/small-businessassistance)
Manufacturing (/tobacco-products/compliance-enforcement-training/manufacturing)
Selling Tobacco Products in Retail Stores (/tobacco-products/retail/summary-federalrules-tobacco-retailers)
Menthol and Other Flavors in Tobacco Products (/tobacco-products/productsingredients-components/menthol-and-other-flavors-tobacco-products)
https://www.fda.gov/tobacco-products/products-ingredients-components/cigarettes
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