By Timothy S. Donahue
Top Takeaways:
- The FDA is asking OMB to renew the paperwork requirement for smokeless tobacco warning rotation plans under the Paperwork Reduction Act.
- The plans must show how mandated warnings will be randomly distributed across packaging and rotated quarterly in advertising for each smokeless brand.
- The FDA estimates the annual paperwork burden at 120 hours and says it removed cigar warning plans from this collection.
The FDA is seeking federal approval to continue requiring smokeless tobacco companies to submit warning “rotation plans” — documents that explain how mandatory health warnings will be randomly placed on packaging and rotated in advertising.
A notice has been published in the Federal Register on Jan. 16, 2026. The U.S. Food and Drug Administration said it has submitted an information collection request to the Office of Management and Budget (OMB) for review under the Paperwork Reduction Act. Public comments are due within 30 days of publication.
The collection, titled “Warning Plans for Certain Tobacco Products,” is assigned OMB Control Number 0910-0671, the agency said.
Under federal law, smokeless tobacco products must carry one of four required warning statements. FDA’s notice explains that companies must submit a plan showing how those warnings will be delivered.
- randomly displayed on smokeless tobacco packages, and
- randomly distributed across the product line
The plan must be submitted to the FDA and approved before it can be used.
The FDA also said that smokeless tobacco warnings must be rotated every quarter in advertisements for each brand, under an FDA-approved warning plan. In other words, the FDA wants to ensure companies don’t repeatedly use the same warning on most packages or ads. The plan is meant to document how all four warnings will appear and rotate, as required by the law.
The FDA said these requirements come from the Comprehensive Smokeless Tobacco Health Education Act of 1986 and were amended by the Family Smoking Prevention and Tobacco Control Act. The notice states that the law requires smokeless tobacco packages and advertisements to carry one of four warnings, displayed and distributed randomly “in accordance with a plan submitted to and approved by FDA.”
The FDA said that warning plans can be submitted either electronically or in paper format. The notice references the Center for Tobacco Products (CTP) Portal as a secure online submission system for these materials.
The FDA said public comments on the OMB submission must be filed through reginfo.gov within 30 days of Federal Register publication. The agency also noted that it previously issued a 60-day notice on July 3, 2025, and received two comments, neither of which was related to Paperwork Reduction Act burden issues.
FDA included updated paperwork burden estimates, stating that the collection totals 120 hours annually, broken down as follows:
- 1 original smokeless tobacco warning plan submission: 60 hours
- 2 supplements (updates or additions to approved plans): 30 hours each
FDA said this represents a reduction of 60 hours and two respondents from the currently approved burden, based on historical submission patterns. As of the time of the OMB submission, FDA reported it had received:
- 47 original smokeless warning plans, and
- 33 supplements to existing plans
The FDA also stated that the cigar warning plan burden has been removed from the information collection since the earlier 60-day notice was published.
