The National Association of Tobacco Outlets (NATO) on Feb. 19 requested clarification from the Food & Drug Administration (FDA) that a wholesaler’s cigarette web-based or printed order guide/order catalog for retailers to order cigarettes to stock their stores is not an “advertisement” within the meaning of the Family Smoking Prevention and Tobacco Control Act.
For background purposes, tobacco wholesalers generally utilize either a web-based or printed order guide or order catalog format. The question arose whether a web-based or printed order guide/order catalog constitutes an advertisement and, for that reason, would require the new graphic cigarette health warnings to appear on each web page and order guide/order catalog page that lists cigarettes.
In a letter sent by the FDA to NATO, FDA Director of Compliance and Enforcement Ann Simoneau clarified that “FDA does not intend this rule to reach the examples you describe of web-based or printed wholesaler’s order guides that are limited to verified retail accounts that do business with a wholesaler and are not publicly accessible. These examples appear to be purely business-related communications that will not be seen by consumers, including minors.”
This means that a web-based or printed order guide/order catalog for retailers to order cigarettes is not an “advertisement” within the meaning of the Family Smoking Prevention and Tobacco Control Act and wholesalers are not required to submit a cigarette health warning rotational plan to the FDA nor include the graphic cigarette health warnings on the web pages or order guide/order catalog pages that list cigarettes.
Cigarette Health Warning Rotational Plans
As previously reported in the NATO News Bulletin on March 2, the U.S. District Court for the Eastern District of Texas issued an order postponing by 90 days the effective date of the FDA’s graphic cigarette health warning rule from Jan. 14, 2022, to April 14, 2022. The order also stated that “any other obligation to comply with a deadline tied to the effective date of the rule” is also postponed for an additional 90 days.
In the letter that the FDA sent to NATO, the agency also confirms that “[p]ursuant to the court order, any obligation to comply with a deadline tied to the effective date of the rule is similarly postponed, and those obligations and deadlines are now tied to the postponed effective date.”
This means that the FDA’s preferred submission date for retailers, wholesalers, and manufacturers which create their own cigarette advertisements to submit a cigarette health waring rotational plan to the agency is now postponed 90 days from March 16, 2021, to June 14, 2021.