APPENDIX
4.2

EXAMPLE OF MODIFICATIONS TO RULES IN RESPONSE TO NEW INFORMATION AND OPERATIONAL CHANGES

What follows is the US Food and Drug Administration’s explanation of its effort to promulgate new rules regulating the warnings on cigarette packages. As the initial statement shows, by the spring of 2020, the decision on these efforts was delayed because of the COVID-19 pandemic.

Cigarette Labeling and Health Warning Requirements

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.

Required Health Warnings

The Family Smoking Prevention and Tobacco Control Act (TCA) granted FDA important 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.

The new required warnings must appear prominently on cigarette packages and in cigarette advertisements, occupying the top 50 percent of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of advertisements.

As explained in the final rule, each required warning must be accurately reproduced as shown in the materials contained in “Required Cigarette Health Warnings, 2020,” which is incorporated by reference at 21 CFR 1141.5.

FDA recognizes that adaptations to the required warnings may be needed to avoid technical implementation issues due to the varying features, formats, and sizes of cigarette packages and advertisements. To help prevent distortion of the image and text and to minimize the need for adaptation, FDA has created electronic, layered design files, built as Encapsulated PostScript (.eps) files, in different formats and aspect ratios designed to fit packaging and advertising of various shapes and sizes. FDA is not requiring the use of these .eps files, but rather we are providing the files as a resource to assist regulated entities.

In addition to the material incorporated by reference and the .eps files, FDA is making available a technical specifications (i.e., instructions) document that includes information on how to access, select, use, and adapt the appropriate .eps files based on the size and aspect ratio of the display area where the required warning must appear.

See FDA’s “Cigarette Health Warning Design Files and Technical Specifications” to download files and for further instructions.

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.

An illustration shows 11 warning boxes.
Long Description

The details of the illustration are as follows:

  • A woman with a lump in her throat and a warning reads “warning: smoking causes head and neck cancer.”
  • Hands holding a lung toy and the warning read “tobacco smoke causes fatal lung disease in non-smokers.”
  • A man with a cataract in an eye and the warning read “smoking causes cataracts, which can lead to blindness.”
  • A woman sleeping on a bed and a man is sitting next to her. The warning reads “smoking reduces blood flow, which can cause erectile dysfunction.”
  • A child with an oxygen mask and a warning reads “tobacco smoke can harm your children.”
  • A hand holding a container holding blood and a warning reads “smoking causes bladder cancer, which can lead to bloody urine.”
  • Two legs with missing toes and a warning reads “smoking reduced blood flow to the limbs, which can require amputation.”
  • A man smoking with the help of an oxygen tank and a warning reads “smoking causes COPD, a lung disease that can be fatal.”
  • A person using a glucose monitor and a warning reads “smoking causes type 2 diabetes, which raises blood sugar.”
  • A baby lying on a weighing machine and a warning reads “smoking during pregnancy stunts fetal growth.”
  • A man with a plug attached below his shoulder and a warning reads “smoking cause heart disease and strokes by clogging arteries.”

Interactive Cigarette Health Warning

[Author’s note: Included on the website was a three-dimensional image of a cigarette pack that a user can manipulate with a mouse.]

Use your mouse to rotate this 3D image of one of FDA’s new proposed cigarette health warnings to see what it would look like on a cigarette package. You can also download this interactive image, and share it on your digital space.

Cigarette Packages

  • 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.

Cigarette Advertisements

  • 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

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 on 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” 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 soon as possible after publication of the final rule, and in any event by Dec. 16, 2020.

Early submission of cigarette plans will facilitate timely FDA review prior to the Oct. 16, 2021 effective date of the required warnings, encourage dialogue with entities regarding any implementation concerns, and provide the ability to consider proposals from 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).

If a higher volume of submissions is received than is currently expected, FDA intends to ensure that entities who submit an adequate plan by Dec.16, 2020 and who work in good faith with FDA to complete its review are not delayed or prevented from distributing or advertising cigarette packages or advertisements due to the agency not having approved their plans by the effective date of the final rule (i.e., Oct. 16, 2021).

For efficiency of review, FDA recommends that, to the extent possible, manufacturers, distributors, and retailers submit a single cigarette plan that covers both cigarette packaging and cigarette advertising, rather than submitting each plan separately, when applicable.

For FDA to approve a cigarette plan for cigarette packaging, the plan must provide that all of the required warnings are randomly displayed during each 12-month period on each brand of the product, displayed on each brand of the product in as equal a number of times as is possible during each 12-month period, are randomly distributed in all areas of the United States in which the product is marketed, and must ensure that all of the required warnings will be displayed by the manufacturer, distributor, or retailer at the same time.

For FDA to approve a cigarette plan for cigarette advertising, the plan must provide that all of the required warnings are rotated quarterly in alternating sequence in advertisements for each brand of cigarettes.

Source: US Food and Drug Administration (FDA), 2020, “Cigarette Labeling and Health Warning Requirements,” last updated June 17, www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/cigarette-labeling-and-health-warning-requirements.