Due to the COVID-19 pandemic and its disruptive impacts on both regulated industry and FDA, on May 8 the U.S. District Court for the Eastern District of Texas granted a joint motion in the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20-cv-00176, to govern proceedings in that case and postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule by 120 days. FDA remains fully committed to the rule and would not agree to postpone its effective date but not for the extraordinary disruptions caused by the COVID-19 pandemic.
The new effective date of the final rule is Oct. 16, 2021. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. FDA strongly encourages entities to submit cigarette plans (as required by 21 CFR 1141.10(g)) as soon as possible, and in any event by Dec. 16, 2020. FDA has updated the “Required Warnings for Cigarette Packages and Advertisements” small entity compliance guide and the “Submission of Plans for Cigarette Packages and Cigarette Advertisements” guidance to include the rule’s new effective date and updated timing for submission of cigarette plans. Regulated industry may contact CTP with questions about the effective date.
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.
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 provisions
- Chart on compliance and effective dates
- 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 Products
Labeling 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 Descriptors
Guidances 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)
- Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule (Revised)
- Advertising and Promotion
- Selling Tobacco Products in Retail Stores
- Tobacco Control Act
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.