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  4. Labeling and Warning Statements for Tobacco Products
  1. Products, Guidance & Regulations

Labeling and Warning Statements for Tobacco Products

Learn 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.

Labeling and Warning Statement Requirements

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

Guidances Related to Labeling and Warning Statement Requirements

Additional Resources

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. 

 



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