Tobacco Products

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.

Relevant Dates

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

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

  • 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


1. The United States District Court for the District of Columbia recently issued an order enjoining FDA from enforcing the health warnings requirements for cigars and pipe tobacco set forth in 21 CFR §§ 1143.3 and 1143.5 until 60 days after final disposition of the plaintiffs’ appeal of the court’s order on the health warnings requirements. See Order, Cigar Ass’n of Am. v. U.S. Food & Drug Admin., No. 1:16-cv-01460 (D.D.C. July 5, 2018). The compliance date for the health warnings requirements in 21 CFR part 1143 is August 10, 2018. FDA intends to comply with the court’s order in Cigar Association of America. In addition, the agency does not intend to enforce the labeling requirements under sections 903(a)(2) and 920(a)(1) for cigars and pipe tobacco while the injunction is in effect so that firms may make these required label changes at one time. See 81 Fed. Reg. at 29,006 (noting that compliance date for the 903(a)(2) and 920(a)(1) requirements is intended to match date for health warnings). We note that cigar and pipe tobacco firms may choose to voluntarily comply with 21 CFR §§ 1143.3 and 1143.5 and sections 903(a)(2) and 920(a)(1) while the injunction is in effect. 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. 


 

Page Last Updated: 08/13/2018
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