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.
FDA’s final rule, “Required Warnings for Cigarette Packages and Advertisements,” establishes new required cigarette health warnings for cigarette packages and advertisements. Each required warning, comprising a textual warning statement and its accompanying color graphic, 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.
As discussed in the final rule, 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 is making available here the 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. As explained in the preamble to the final rule, FDA is not requiring the use of these .eps files, but rather we are providing the files as a resource to assist regulated entities implement part 1141.
In addition to 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 .eps files based on the size and aspect ratio of the display area where the required warning must appear. Regulated entities may also reference “Required Cigarette Health Warnings, 2020,” to identify the specific file name of the corresponding .eps file for a required warning.
For assistance accessing or using the .eps files, contact CTP at firstname.lastname@example.org.
Available .eps Files for Required Cigarette Warnings
Each of the 11 required warnings is available in two versions: one with a white background with black text, and one with a black background with white text. These 22 versions are available below in 6 different artwork sizes for both cigarette packages and cartons, and in 8 different aspect ratios for advertisements, for a total of 440 individual .eps files. Each .eps file contains multiple layers with the elements of each required warning (e.g., photorealistic illustration, textual warning statement, background, border), as well as additional content helpful in using and adapting the files (e.g., crop marks, bleeds). For the advertisement versions, this also includes the option to substitute the Spanish-language version of the textual warning statements for the English-language version, as appropriate.
For ease of download, and given the large size of the .eps files, we have grouped files together by type and artwork size/aspect ratio. Click on the link for the desired artwork size/aspect ratio below to download a zip file containing all the 22 .eps files for the required warnings in that size/aspect ratio.
[Note: The starting artwork size is 2in x 2in]