Tobacco Compliance Under the Microscope: FDA Renews Its Violation Reporting Process

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The U.S. Food and Drug Administration (FDA) is seeking approval from the Office of Management and Budget (OMB) to continue collecting information from consumers and other stakeholders about potential violations involving tobacco products. 

The notice, published in the Federal Register on August 31, 2026, concerns the continued use of Form FDA 3779, Potential Tobacco Product Violations Report, under OMB Control Number 0910-0716. The FDA is accepting public comments on the proposed extension through September 30, 2026.

The FDA is requesting an extension of its existing information collection under the Paperwork Reduction Act of 1995 (PRA). The request does not establish a new reporting requirement or create new tobacco product restrictions. Instead, it allows the FDA to continue using its existing process for receiving reports from the public about potential violations of federal tobacco laws.

The information collection supports the FDA's enforcement responsibilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act. Tobacco products are generally regulated under Chapter IX of the FD&C Act, which gives the FDA authority to monitor compliance and take corrective action when violations occur.

The FDA's reporting system is intended to receive information concerning a broad range of potential tobacco product violations. Examples identified in the notice include sales of tobacco products to individuals under 21; sales of flavored cigarettes; illegal tobacco product marketing or advertising; distribution of free tobacco product samples, except where permitted; improper placement or access to cigarette or smokeless tobacco vending machines; manufacture or sale of unauthorized tobacco products; and sale of cigarettes in packages containing fewer than 20 cigarettes. These reports can provide the FDA with information about potential violations that may otherwise be difficult for the Agency to identify through its own monitoring activities.

Form FDA 3779 allows individuals and other interested parties to provide details about a suspected violation. The form requests information such as the date of the potential violation, the type and brand of tobacco product involved, and the type of violation being reported. Filers may also provide information about potentially violative promotional materials, describe what occurred, and identify the person or business believed to be responsible. If available, the report can include the potential violator's name, address, and website or internet address.

The form also allows individuals to provide contact information voluntarily if the FDA needs additional information or if the filer wants confirmation that the complaint was received. Supporting documents or other relevant information may also be submitted. 

The FDA currently accepts potential tobacco product violation reports through several channels. Form FDA 3779 can be submitted online, by email, or by postal mail. Individuals may also contact the FDA's Tobacco Call Center. The FDA provides additional information about reporting potential violations through its tobacco compliance and enforcement resources.

As part of its request to OMB, the FDA estimates that approximately 3,000 respondents will submit reports each year, with an average of two reports per respondent. Based on those estimates, the FDA expects approximately 6,000 responses annually. The Agency estimates that each report will take approximately 15 minutes to complete and submit, resulting in an estimated total annual reporting burden of 1,500 hours.

The FDA states that there are no capital costs or operating and maintenance costs associated with this information collection. The Agency also reports that it has made no adjustments to its previous burden estimate following its review of the collection.

Public comments are open through September 30, 2026. The FDA previously published a 60-day notice regarding this information collection on June 23, 2026. According to the August 31 notice, the FDA received no comments during that earlier comment period.

The current notice gives the public another opportunity to provide comments and recommendations before the FDA's information collection is reviewed by OMB. Comments should reference OMB Control Number 0910-0716 and FDA Docket No. FDA-2026-N-6540. Comments are recommended to be submitted through the OMB's information collection review system by September 30, 2026.

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