FDA Cigarette Health Warning Plans

What retailers and distributors need to know

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FDA Cigarette Health Warning Plans

The following article was contributed by the National Association of Tobacco Outlets (NATO)

In March of this year, the U.S. Food and Drug Administration (FDA) issued a final regulation to require new text and graphic picture warnings on cigarette packages, cigarette cartons, and cigarette advertisements.  These new cigarette health warnings consist of eleven text statements that are accompanied by a specific graphic color image (see text and graphic color image warnings shown in the Exhibit at the end of this article).  The implementation date for the new cigarette health warnings is October 16, 2021 and the FDA is requesting that industry members file cigarette warning plans as soon as possible and preferably by December 16, 2020 to ensure that the agency has sufficient time to review the plans prior to October of 2021.

Note: The information utilized for this article is contained in the two accompanying FDA Guidance documents titled “Required Warnings for Cigarettes Packages and Advertisements” (referred to as “Warnings Guidance”), and “Submission of Plans for Cigarette Packages and Cigarette Advertisements” (referred to as “Submission Guidance”).  These documents should be referred to for additional details on the requirements to submit a cigarette health warning plan for cigarette advertisements to the FDA).

Litigation Note: On April 3, 2020, R.J. Reynolds Tobacco Company, along with several other manufacturers and five retailers, filed a federal lawsuit against the FDA in the Federal District Court for the Eastern District of Texas to invalidate both the FDA’s recently issued rule for new text and graphic cigarette health warnings and Congress’s requirement that the FDA mandate these warnings.  Also on May 6, 2020, Philip Morris USA Inc. and Sherman Group Holdings, LLC filed a federal lawsuit against the FDA in the Federal District Court for the District of Columbia seeking to invalidate the graphic warnings rule and Congress’s requirement that the FDA mandate these warnings.  These lawsuits are pending, but no court rulings have been issued on the merits of either case at this time.  Those retailers and distributors which would be required to submit a cigarette health warning plan to the FDA should proceed to do so unless and until any court decisions would impact the requirement to file a plan.

Who Must File a Cigarette Health Warning Plan for Cigarette Advertisements: Manufacturers, distributors, and retailers that sell cigarettes and produce cigarette advertisements are required to submit a plan to the FDA which describes the random and equal display of the eleven text and graphic warnings on a quarterly basis. According to the agency, “a retailer typically would not submit a cigarette plan for advertising supplied by the manufacturer of a tobacco product if the advertising is already covered by an FDA-approved cigarette plan submitted by the manufacturer.” In other words, the key factor in determining whether a distributor or retailer needs to file a cigarette health warning plan and then include the cigarette text and graphic warning on cigarette advertisements is whether a distributor or retailer actually produces the cigarette advertisement. Also, the FDA must approve each cigarette health warning rotation plan for cigarette advertisements to ensure that the rotation of the eleven warnings is random and completed on a quarterly basis.

Type of Advertisements Covered by the Regulation: According to the Warnings Guidance, the FDA states that “[a]ll cigarette packages and advertisements, regardless of type, must display the required warnings, in accordance with an FDA approved cigarette plan.”  While the FDA regulations do not define the term “advertisement,” the agency does list the following kinds of advertising medium that are required to display the new cigarette health warnings if produced by manufacturers, distributors, or retailers:

  • Print advertisements in newspapers and magazines
  • Posters, placards, and signs
  • Point of sale “shelf talker”
  • Website pages
  • Social media websites/pages
  • Digital platforms and digital banner ads
  • Mobile applications
  • Mobile coupons
  • E-mail correspondence
  • Direct mail advertisements
  • Billboards

Health Warning Size and Placement:  The required warnings must be indelibly printed or permanently affixed to a cigarette advertisement.  In addition, required warnings must comprise at least 20 percent of the area of a cigarette advertisement in a conspicuous and prominent format and be positioned at the top of each advertisement within the trim area, if any.  Also, even if the cigarette advertisement only contains text without any images, the advertisement must bear a text and graphic image health warning.