By: Stacy Ehrlich and Justine E. Lenehan
On March 18, 2020, the Food and Drug Administration (FDA) published a final rule (21 C.F.R. Part 1141) requiring textual and graphic health warnings to be included on all cigarette packages and advertisements. FDA simultaneously published two related guidance documents: (1) Required Warnings for Cigarette Packages and Advertisements, Small Entity Compliance Guide (Compliance Guide), assisting small businesses in complying with these new requirements and (2) Submission of Plans for Cigarette Packages and Cigarette Advertisements (Cigarette Plan Guidance), containing recommendations on the preparation and submission of required cigarette plans for packages and advertisements.
The final rule will take effect 15 months from the date of publication (June 18, 2021).
Section 201 of the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act), amending the Federal Cigarette Labeling and Advertising Act, required FDA to promulgate regulations no later than June 22, 2011, mandating textual and graphic warning statements for cigarette packages and advertisements. On that date, FDA published a final rule detailing the cigarette graphic warning requirements which was subsequently challenged in the United States District Court for the District of Columbia by a group of tobacco product manufacturers and sellers. The court found that the warning labels required by the 2011 final rule were unconstitutional. On appeal, the Court of Appeals for the District of Columbia Circuit affirmed this decision and vacated and remanded the final rule to FDA.
In October 2016, several public health organizations and individual pediatricians filed a lawsuit in the United States District Court for the District of Massachusetts seeking to compel FDA to promulgate a new final rule under section 201 of the Tobacco Control Act. The court ordered FDA to:
- Complete its final qualitative study and analysis of the nine proposed warning labels by April 15, 2019;
- Submit the proposed rule for publication in the Federal Register by August 15, 2019; and
- Submit the final rule for publication in the Federal Register by March 15, 2020.
Consistent with the court’s order, FDA published a proposed rule on August 16, 2019, containing 13 health warnings for cigarette product packages and advertisements. Following the comment period, FDA published a final rule on March 18, 2020, replacing 21 C.F.R. Part 1141 with 11 new cigarette health warnings required to appear on cigarette packages and advertisements.
The final rule establishes new health warning requirements for cigarette packages and advertisements that incorporate textual warning label statements accompanied by color graphics depicting negative health consequences of smoking. After the relevant compliance dates, if a cigarette package or cigarette advertisement fails to bear one of the required warnings in accordance with the requirements detailed at Part 1141, the cigarette is deemed misbranded under sections 903(a)(1) or 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FDCA), respectively.
The warning requirement generally applies to manufacturers, distributors, and retailers of cigarettes, except in the following circumstances:
- Manufacturers or distributors that do not manufacture, package, or import cigarettes for sale or distribution within the United States are not subject to 21 C.F.R. Part 1141.
- Retailers will not be in violation of section 1141.10 (Required warnings) if the packaging:
- contains a warning;
- is supplied to the retailer by a license- or permit-holding tobacco product manufacturer or distributor; and
- is not altered by the retailer in a way that is material to the health warning requirements (for instance, by displaying or selling cigarette packages that are obscured by stickers, sleeves, or other materials on the packages).
- Retailers are not subject to section 1141.10(d) (Advertisements) unless that retailer is responsible for or directs the warnings required under section 1141.10 for advertising. Note, however, that this does not relieve a retailer of liability if the retailer displays an advertisement in a location open to the public that does not contain a warning or has been altered by the retailer in a way that is material to the health warning requirements.
Generally, the rule requires that the textual and graphic warning be affixed directly on the product package and clearly visible underneath any wrapping. The warning must occupy at least the top (or left, depending on the package type) 50% of the front and rear panels and be oriented in the same direction as any other information on that panel.
The required warnings 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 be randomly distributed in all areas of the United States in which the product is marketed in accordance with an approved plan.
The term advertisement is intended to be understood broadly and would include, but is not limited to, advertisements on signs, retail displays, internet web pages, digital platforms, and e-mail correspondence. The final rule details the format and marketing requirements of the health warning in cigarette advertisements. Generally, the rule requires that the textual and graphic warning conspicuously and prominently occupy at least the top 20% of the advertisement within any trim area. The required warnings must be rotated quarterly in alternating sequence in advertisements for each brand of cigarettes in accordance with an approved plan.
As noted above, manufacturers, distributors, and retailers are required to submit plans for the random and equal display and distribution of required warnings on cigarette packages and the quarterly rotation of required warnings on cigarette advertisements, and to obtain FDA approval of such plans prior to the product entering the market. FDA issued its Cigarette Plan Guidance to make recommendations on how to prepare and submit such plans.
FDA did not impose a deadline for submission of cigarette plans but strongly recommends that such plans be submitted as soon as possible, and in any event by August 18, 2020, in order to ensure that the Agency has sufficient review time before the warning requirements take effect on June 18, 2021.
The Cigarette Plan Guidance provides further detail on the following topics:
- The recommended timeline for submission of cigarette plans and FDA’s approval timeline;
- The circumstances under which a new cigarette plan and/or a supplement to an approved plan should be submitted;
information to be provided in a cigarette plan, including:
- A cover letter (while not required by FDA, the Agency recommends a cover letter accompany each submission and details with a fair amount of specificity the information it expects to see in such a cover letter);
- Sufficient information to demonstrate that all required warnings will be randomly and equally displayed and distributed in the case of cigarette packages or rotated quarterly in the case of cigarette advertisements (including a detailed description of how each of these elements will be achieved);
scope of a cigarette plan, including:
- Whether the plan covers both cigarette packages andadvertisements for a particular brand;
- Whether the plan covers multiple brands;
- Whether the plan covers all brands in a manufacturer’s product listing under section 905(i) of the FDCA (and/or incorporates any new, future brands into an approved plan);
- Considerations in determining the most appropriate entity to submit the cigarette plan; and
- Logistics related to the submission of a cigarette plan.
Relevant Compliance Dates
August 18, 2020 – The date by which FDA strongly recommends that cigarette plans be submitted to FDA for approval.
June 18, 2021 – Effective date of final rule. As of this date, cigarette packages and cigarette advertisements that do not contain a required warning may not be manufactured for sale or distribution or be advertised, as appropriate, in the United States.
July 18, 2021 – After this date (30 days after the effective
date), a manufacturer may not introduce into domestic commerce any product, irrespective
of the date of manufacture, that does not conform with the final rule. FDA notes in the Compliance Guide that after
the effective date, distributors and retailers may continue to sell and
distribute their remaining stock of cigarette products even if the packaging
does not comply with the final rule if the product was (1) manufactured before
the effective date and (2) introduced into domestic commerce by the
manufacturer within 30 days from the effective date of the rule.
 85 Fed. Reg. 15,638 (March 18, 2020) (revising 21 C.F.R. Part 1141).
 R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d 1205 (D.C. Cir. 2012).
 American Academy of Pediatrics, et al. v. FDA, 330 F.Supp.3d 657 (D. Mass. 2018).
 84 Fed. Reg. 42,754 (Aug. 16, 2019).
 21 U.S.C. § 387c(a)(1), (a)(7)(A).
 21 C.F.R. § 1141.12.
 21 C.F.R. § 1141.1.
 See 21 C.F.R. § 1141.10(d), (e), (g).
 See 21 C.F.R. § 1141.10(g).
 Compliance Guide at 7 (Question D.4).