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 In this section:

                Products, Ingredients & Components

Products, Ingredients & Components

                        Cigarettes
          Chemicals in Cigarettes: From Plant to Product to Puff
          Cigars, Cigarillos, Little Filtered Cigars
          Dissolvable Tobacco Products
          E-Cigarettes, Vapes, and other Electronic Nicotine Delivery Systems (ENDS)
          Menthol and Other Flavors in Tobacco Products
          Harmful and Potentially Harmful Constituents (HPHCs)
          Hookah Tobacco (Shisha or Waterpipe Tobacco)
          Nicotine Gels
          Regulation and Enforcement of Non-Tobacco Nicotine (NTN) Products
          Roll-Your-Own Tobacco
          Pipe Tobacco
          Smokeless Tobacco Products, Including Dip, Snuff, Snus, and Chewing Tobacco Home
          Tobacco Products
          Products, Guidance & Regulations
          Products, Ingredients & Components
          Cigars, Cigarillos, Little Filtered CigarsProducts, Ingredients & Components Cigars, Cigarillos, Little Filtered Cigars
  
  	
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FDA Regulation of Cigars
	Manufacturing Cigars
	Warning Statement Requirements and Warning Plans
	Retail Sales of Cigars
	Importing Cigars
	Reporting Adverse Experiences and Product ViolationsA 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

____________________

FDA Regulation of Cigars

On August 9, 2023, the U.S. District Court for the District of Columbia issued an order in the case of Cigar Association of America, et al. v. United States Food and Drug Administration et al., No. 16-cv-01460, vacating “the FDA’s decision to deem premium cigars.” On Sept. 29, 2023, the government filed an appeal of the district court’s order. FDA will provide further updates as appropriate.

**Cigars, Cigarillos, Little Filtered Cigars**



**Click for larger version**

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.

In 2022, FDA issued a proposed product standard to prohibit all characterizing flavors (other than tobacco) in cigars.

Manufacturing Cigars

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.

Warning Statement Requirements and Warning Plans

The United States District Court for the District of Columbia recently issued an order vacating the health warning requirements for cigars and pipe tobacco set forth in 21 CFR §§ 1143.3 and 1143.5 and remanding the Final Deeming Rule’s warning requirements for cigars and pipe tobacco back to the Agency. See Order, *Cigar Ass’n of Am. v. U.S. Food & Drug Admin*., No. 1:16-cv-01460 (D.D.C. September 11, 2020). Although the requirement has been vacated, cigar and pipe tobacco firms may choose to voluntarily comply with these health warning provisions. FDA will continue to enforce the other requirements it was already enforcing for cigars and pipe tobacco under the FD&C Act and its implementing regulations, such as not selling these products to individuals under 21 years of age or marketing them as modified risk tobacco products without an FDA order.

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.Retail Sales of Cigars

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.

**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.****

Retailer Regulations and Guidance
	Required Warning Statements on Tobacco Product Packaging and AdvertisingImporting Cigars

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.

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.

Additional Resources

Small Business Assistance for Tobacco Product Industry
	Manufacturing
	Selling Tobacco Products in Retail Stores
	FDA's Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products
	Menthol and other Flavored Tobacco Products
	CTP Statement on Premarket Authorization Requirements for Premium Cigars (August 26, 2020)
	CTP Statement on Withdrawal of the Unified Agenda Entry Pertaining to the Advance Notice of Proposed Rulemaking for Premium Cigars and Related Request for Information (June 11, 2021)
	CTP Statement on National Academies Report on Premium Cigars Health Effects (March 10, 2022)References

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. Gentzke AS, Wang TW, Jamal A, et al. Tobacco Product Use Among Middle and High School Students — United States, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1881–1888. Cornelius ME, Wang TW, Jamal A, Loretan CG, Neff LJ. Tobacco Product Use Among Adults — United States, 2019. MMWR Morb Mortal Wkly Rep 2020;69:1736–1742.

                                                                                  Content current as of:
      08/25/2023
              
              
Regulated Product(s)
		 TobaccoTopic(s)
			  ImportProducts, Ingredients & Components

          
                        Cigarettes
          Chemicals in Cigarettes: From Plant to Product to Puff
          Cigars, Cigarillos, Little Filtered Cigars
          Dissolvable Tobacco Products
          E-Cigarettes, Vapes, and other Electronic Nicotine Delivery Systems (ENDS)
          Menthol and Other Flavors in Tobacco Products
          Harmful and Potentially Harmful Constituents (HPHCs)
          Hookah Tobacco (Shisha or Waterpipe Tobacco)
          Nicotine Gels
          Non-Tobacco Nicotine (NTN) Products
          Roll-Your-Own Tobacco
          Pipe Tobacco
          Smokeless Tobacco Products, Including Dip, Snuff, Snus, and Chewing Tobacco
 
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