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        Products, Guidance & Regulations

Labeling and Warning Statements for Tobacco Products

                        
                Cigar Labeling and Warning Statement Requirements
          Cigarette Labeling and Health Warning Requirements
          Smokeless Tobacco Labeling and Warning Statement Requirements
          "Covered" Tobacco Products and Roll-Your-Own/ Cigarette Tobacco Labeling and Warning Statement Requirements
          Light, Low, Mild or Similar Descriptors Home
          Tobacco Products
          Products, Guidance & Regulations
          Labeling and Warning Statements for Tobacco ProductsProducts, Guidance & Regulations Labeling and Warning Statements for Tobacco Products
  	
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    PrintLearn more about labeling and warning statement requirements for tobacco products under the Federal Food, Drug & Cosmetic Act (FD&C Act) and its implementing regulations.

For deemed products, FDA has also provided a compliance period for certain modified risk tobacco product requirements.

Relevant Dates

For tobacco products regulated by the deeming final rule, FDA has provided a compliance period for certain labeling and advertising requirements:

FDA has provided a compliance date of **August 10, 2018,**for the required health warning statements on packages and advertisements for "covered" tobacco products (except cigars and pipe tobacco1) and roll-your-own / cigarette tobacco products.2
	Summary of deeming related provision
	**November 8, 2017**: stop manufacturing tobacco products, the label, labeling, or advertising of which uses the descriptors “light,” “mild,” “low” or similar descriptors unless you have a Modified Risk Tobacco Product order in effect. (Stop distributing these modified risk tobacco products in interstate commerce by December 8, 2017.)For all other deemed, modified risk tobacco products, stop introduction or delivery for introduction into interstate commerce as of the effective date of the deeming rule (**August 8, 2016**), *unless you have a Modified Risk Tobacco Product order in effect*.

Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Deemed Tobacco ProductsLabeling and Warning Statement Requirements

Labeling and warning statement requirements for packages and advertisements, including:

Retailers: Chart of Required Warning Statements on Tobacco Product Packaging and Advertising
	Cigar Labeling and Warning Statement Requirements
	Cigarette Labeling and Warning Statement Requirements
	Roll-Your-Own/ Cigarette Tobacco Labeling and Warning Statement Requirements
	Smokeless Tobacco Labeling and Warning Statement Requirements
	Covered Tobacco Products and Roll-Your-Own / Cigarette Tobacco Labeling and Warning Statement Requirements, including: hookah (waterpipe) tobacco, pipe tobacco, vaporizers, e-cigarettes, and other electronic nicotine delivery systems
	Light, Low, Mild or Similar DescriptorsGuidances Related to Labeling and Warning Statement Requirements

Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco
	Small Entity Compliance Guide: FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements
	Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products
	Compliance Policy for Required Warning Statements on Small-Packaged Cigars
	Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops
	Tobacco Retailer Training Programs (Revised)Additional Resources

Advertising and Promotion
	Manufacturing
	Selling Tobacco Products in Retail Stores
	Tobacco Control ActReferences

1. 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. The court's order does not enjoin FDA from enforcing the health warning requirements for other product categories, including Electronic Nicotine Delivery Systems (ENDS) products, hookah tobacco, and cigarette tobacco and roll-your-own tobacco products. See Guidance: Compliance Policy for Required Labeling and Warning Statements on Cigars and Pipe Tobacco
2. For 30 days after the compliance date of Aug. 10, 2018, manufacturers of covered tobacco products, roll-your-own tobacco, and cigarette tobacco products may continue to introduce into interstate commerce products with packaging that do not comply with the new health warning requirements only if the products were manufactured before Aug. 10, 2018. Additionally, retailers and distributors may continue to sell products with non-compliant packaging after the compliance date only if the products were manufactured before Aug. 10, 2018. FDA encourages retailers to contact their distributor/supplier for information about the tobacco products in their inventory.

                                                                                  Content current as of:
      06/04/2021
                  
                   
Regulated Product(s)
		 TobaccoLabeling and Warning Statements for Tobacco Products                
                          

                        Cigar Labeling and Warning Statement Requirements
          Cigarette Labeling and Health Warning Requirements
          Smokeless Tobacco Labeling and Warning Statement Requirements
          "Covered" Tobacco Products and Roll-Your-Own/ Cigarette Tobacco Labeling and Warning Statement Requirements
          Light, Low, Mild or Similar Descriptors
 
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