On Aug. 18, the U.S. District Court for the Eastern District of Texas issued an order postponing the new effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule until Oct. 11, 2022.
Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. For example, the U.S. Food and Drug Administration 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. 12, 2021.
The ruling was made in the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., to postpone the effective date of the final rule.
Cigarette Health Warnings
The Family Smoking Prevention and Tobacco Control Act (TCA) granted FDA new authority to regulate the manufacture, marketing and distribution of tobacco products. The TCA also amended Section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA), directing FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The TCA amends the FCLAA to require each cigarette package and advertisement to bear one of the new required warnings.
In March 2020, FDA finalized the “Required Warnings for Cigarette Packages and Advertisements” rule, establishing 11 new cigarette health warnings, consisting of textual warning statements accompanied by color graphics, in the form of concordant photorealistic images, depicting the negative health consequences of cigarette smoking. These new required warnings depict some of the lesser-known but serious health risks of smoking.
FDA has also published the “Required Warnings for Cigarette Packages and Advertisements – Small Entity Compliance Guide” to help small businesses understand and comply with the final rule.
- Size and location – The required warning must comprise at least the top 50 percent of the front and rear panels of the cigarette package (i.e., the two largest sides or surfaces of the package).For cigarette cartons, the required warnings must be located on the left side of the front and rear panels of the carton and must comprise at least the left 50 percent of these panels. The required warning must appear directly on the package and must be clearly visible underneath any cellophane or other clear wrapping.
- Orientation – The required warning must be positioned so that the text of the required warning and the other information on that panel of the package have the same orientation.For example, if the front panel of a cigarette package contains information, such as the brand name of the cigarette, in a left to right orientation, the required warning, including the textual warning statement, must also appear in a left to right orientation.
- Random and equal display and distribution – All 11 required warnings for packages must be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of the product and must be randomly distributed in all areas of the United States in which the product is marketed, in accordance with an FDA-approved cigarette plan.
- Irremovable or permanent warnings – Required warnings must be indelibly printed on or permanently affixed to the cigarette package.For example, these required warnings must not be printed or placed on a label affixed to a clear outer wrapper that is likely to be removed to access the product within the package.
- Size and location – For print advertisements and other advertisements with a visual component (including, for example, advertisements on signs, retail displays, Internet web pages, social media web pages, digital platforms, mobile applications, and email correspondence), the required warning must appear directly on the advertisement. Additionally, required warnings must comprise at least 20 percent of the area of the advertisement in a conspicuous and prominent format and location at the top of each advertisement within the trim area, if any.
- Rotation – The 11 required warnings must be rotated quarterly, in alternating sequence, in advertisements for each brand of cigarettes, in accordance with an FDA-approved cigarette plan.
- Irremovable or permanent warnings – Required warnings must be indelibly printed on or permanently affixed to a cigarette advertisement.
Cigarette Plans for Required Warnings
Section 4 of the FCLAA, as amended by the TCA, and the final rule require manufacturers, distributors, and retailers of cigarettes to submit a plan for the random and equal display and distribution of required warnings on cigarettes packages and the quarterly rotation of required warnings in cigarette advertisements, and to obtain FDA approval of their plans before products required to bear such warnings enter the market.
FDA has issued the “Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised)” guidance to assist those submitting cigarette plans for cigarette packages and advertisements.
The requirement for submission of cigarette plans for cigarette packages and advertisements, and the specific requirements relating to the random and equal display and distribution of the required warnings on cigarette packaging and the quarterly rotation of required warnings in cigarette advertising, appear at Section 4(c) of the FCLAA and 21 CFR 1141.10.
In addition, under Section 201(c) of the TCA and 21 CFR 1141.10(g), the agency must review and approve cigarette plans in advance of any person displaying or distributing packages or advertisements for products that are required to carry the required warnings.
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. 12, 2021. Early submission of cigarette plans will facilitate timely FDA review prior to the effective date of the required warnings, encourage dialogue with entities regarding any implementation concerns, and provide time to consider proposals by entities in a timely manner.
FDA will ensure that its review of cigarette plans will be completed no later than 6 months after receipt of an adequate plan from persons who work in good faith with FDA to complete its review (e.g., persons should work diligently with FDA and be responsive by submitting any requested information in a timely manner).