Federal Register notice: FDA seeks comments on “Warning Plans for Certain Tobacco Products”

Jan.16

The U.S. Food and Drug Administration (FDA) issued a notice stating it has submitted a proposed information collection to the Office of Management and Budget (OMB) for review under the Paperwork Reduction Act.

Key Takeaways

• Agency: U.S. Food and Drug Administration (FDA)

• Action: Information collection submitted to OMB for review and public comment

• Docket/OMB: FDA-2025-N-0956; OMB Control No. 0910-0671 (Extension)

• Publication: Scheduled for the Federal Register on Jan. 16, 2026

• Scope: Smokeless tobacco package/ad warning rotation plans requiring FDA approval

• Burden estimate: 120 hours annually (60 hours for an original plan; 30 hours for a supplement)

• Comment route: reginfo.gov (due 30 days after Federal Register publication)

2Firsts, January 16, 2026

According to the Federal Register, the U.S. Food and Drug Administration (FDA) announced it has submitted a proposed collection of information to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act, with public comments due 30 days after publication.

The notice concerns “Warning Plans for Certain Tobacco Products” and describes requirements for smokeless tobacco warning rotation plans. It cites statutory provisions requiring smokeless tobacco packages and advertisements to bear one of four required warning statements, randomly displayed and randomly distributed in accordance with a plan submitted to and approved by FDA. It also states the warnings must be rotated quarterly in advertisements for each smokeless tobacco brand, also in accordance with an FDA-approved plan.

FDA notes that warning plans may be submitted electronically or in paper format, and references the Center for Tobacco Products (CTP) Portal as a secure online submission system. The notice also states FDA published a 60-day notice on July 3, 2025, and received two comments that were not Paperwork Reduction Act-related.

FDA’s burden estimates in the notice total 120 hours annually: one original smokeless tobacco warning plan submission at 60 hours, and two supplements to approved plans at 30 hours each. FDA states the estimate reflects a decrease of 60 hours and two respondents from the currently approved burden, citing historical trends and reporting that, as of the submission, FDA had received 47 original smokeless warning plans and 33 supplements. The notice also states the cigar warning plan burden has been removed from this collection since publication of the 60-day notice.

Image source: Federal Gazette

References:

[1] Agency Information Collection Activities; Submission for Office of Management and Budget

Also Read:

[1] U.S. Fifth Circuit judges question FDA’s claim it has no de facto ban on flavored refillable e-cigarettes

[2] U.S. vape firms appeal Mississippi synthetic-nicotine ban, citing FDA authority preemption

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