This draft guidance (84 FR 71957) outlines recommendations for industry on what information to include in a cigarette plan proposal, in accordance with previous legislation and proposed rules. In 2009, the Tobacco Control Act added requirements for color graphics and textual warning statements on cigarette packaging outlining the negative consequences of tobacco use; it also required cigarette plans to be submitted to the Food and Drug Association (FDA).
In August 2019, the FDA proposed a new rule (84 FR 42754) regarding rotating the various required warnings on cigarette packaging so that each warning is equally displayed and distributed throughout the country. Once the proposed rule is finalized, tobacco companies must submit cigarette plans to the FDA within 5 months. This draft guidance clarifies the requirements for these cigarette plans, including considerations for the rotation and disbursement schedules for the images and textual warnings displayed on tobacco products.
The proposed rule includes 13 potential warnings and associated images, any or all of which can be approved by the FDA. According to the draft guidance, companies would submit their cigarette plans and propose a method to review and rotate these warnings in order to comply with the Tobacco Control Act. Manufacturers, distributors, or retailers would be the entities responsible for providing packaging and advertising plans and obtaining FDA approval prior to enacting said plans. The FDA also created recommendations so that manufacturers, distributors, or retailers could submit one plan for both the packaging and advertising of individual or multiple brands.
A submitted cigarette plan should contain the necessary information for FDA approval, including:
- A cover letter, which includes the scope of the plan;
- The packaging information, with a detailed plan ensuring all required warning are displayed at the same time;
- An advertising plan ensuring all required warning are displayed at the same time and that warnings are rotated quarterly; and
- Representative samples of both the packaging and advertisements.
Guidances are not legally binding, and serve only to inform industry of the FDA’s current thinking on certain topics. This draft guidance is meant to clarify and support the rule proposed in August 2019.