FDA Issues Draft Guidance: Modifications to Compliance Policy for Certain Deemed Tobacco Products
The guidance discusses changes to the compliance policies for premarket review requirements for certain deemed tobacco products, including flavored e-cigarettes and cigars, and describes how FDA intend to prioritize its enforcement of products that do not have premarket authorization.
On this page:
- Statistics about Cigar Use
- FDA Regulation of Cigars
- Manufacturing Cigars
- Warning Statement Requirements and Warning Plans
- Retail Sales of Cigars
- Importing Cigars
- Reporting Adverse Experiences and Product Violations
A cigar is a roll of tobacco wrapped in leaf tobacco or in a substance that contains tobacco. Most cigars are combustible tobacco products. They vary in size—from smaller cigars, such as little filtered cigars or cigarillos, to larger ones, such as large so-called premium cigars.
Cigars are not a safe alternative to cigarettes and cigar smoke is at least as toxic as cigarette smoke, if not more. Large cigars can deliver as much as 10 times the nicotine, two times the tar, and more than five times the carbon monoxide of a filtered cigarette.1
There are cigar products available on the market that resemble cigarettes in size and shape but are labeled as “little cigars” or “filtered cigars.” Little filtered cigars as well as cigarillos might contain candy or fruit flavors that appeal to adolescents and young adults.2,3 In addition, young adults may think that cigars are less addictive and present fewer health risks than cigarettes, but cigars may actually be worse.4,5,10
- Each day, on average, nearly 2,000 youth under age 18 years of age smoked their first cigar.6
- In 2017, 7.7% (an estimated 1.1 million) of high school students and 1.5% (an estimated 170,000) of middle school students reported smoking a cigar within the past 30 days.7
- An estimated 9.3 million adults in the U.S. currently smoke cigars7
In 2016, FDA finalized a rule extending our regulatory authority to cover cigars, and all other tobacco products, except accessories of those products. FDA regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of cigars. This includes components and parts such as rolling papers and filters, but excludes accessories such as lighters and cutters.
If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import cigars, 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.
All "covered" tobacco products, including cigars, must bear required warning statements and additional required statements on product packages and advertisements. Cigar warning plans must also be submitted. For more information, see:
- Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco
- Required Warning Statements on Tobacco Product Packaging and Advertising.
If you sell cigars, please read this summary of federal rules that retailers must follow. You may also order flyers with rules for cigar sales or download a PDF to print yourself. You can find a list of retailer responsibilities for cigars in the final rule Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act.
- Retailer Regulations and Guidance
- Required Warning Statements on Tobacco Product Packaging and Advertising
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.
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. National Cancer Institute (NCI). Cigars: Health Effects and Trends Tobacco Control Monograph 9. Bethesda, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Institutes of Health, National Cancer Institute; 1998.
2. Villanti AC, Richardson A, Vallone DM, et al. Flavored tobacco product use among U.S. young adults. American Journal of Preventive Medicine. 2013; 44(4):388–391.
3. U.S. Department of Health and Human Services (USDHHS). A Report of the Surgeon General: Preventing Tobacco Use among Youth and Young Adults. We Can Make the Next Generation Tobacco-Free (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; 2012.
4. Office of Inspector General, U.S. Department of Health and Human Services. Youth Use of Cigars: Patterns of Use and Perceptions of Risk. 1999.
5. Malone R, Yerger V, Pearson C. Cigar risk perception in focus groups of urban African American youth. Journal of Substance Abuse. 2001; 13(4):549–561.
6. 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/cbhsq-reports/NSDUHDetailedTabs2017/NSDUHDetailedTabs2017.pdf. Accessed October 12, 2018. (Original Data Source: NSDUH 2017, Table 4.10A)
7. 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. (Original Data Source: NYTS 2017)