Tobacco Products

Cigarettes

New Actions on Flavored Tobacco Products

FDA unveils new steps preventing youth access to flavored tobacco products and announces plans to ban menthol in cigarettes and cigars.

On this page:


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 can damage nearly every organ in the body.2  Nonsmokers are exposed to many of these same chemicals through secondhand smoke.

Statistics about Cigarette Use

  • Every day, on average, nearly 2,300 youth under age 18 smoke their first cigarette and nearly 400 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

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.

In July 2017, the FDA announced a comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death, including pursuing lowering nicotine in cigarettes to non-addictive levels.

“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.


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. 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). 2016 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; 2017. https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2016/NSDUH-DetTabs-2016.htm. Accessed October 12, 2017.
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.

Page Last Updated: 11/16/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English