Key points:
·Tobacco retailer training program: The FDA plans to establish standards to regulate tobacco retailer training programs, covering topics such as federal laws restricting the sale, advertising, and promotion of tobacco products. It is estimated that approximately 239,100 tobacco retailers will need to develop training programs that conform to the guidelines.
·Regulations on tobacco sales: These regulations aim to protect children and adolescents by restricting the sale and distribution of cigarettes and smokeless tobacco. Tobacco product manufacturers, distributors, and retailers are required to notify the FDA at least 30 days before using any advertising or labeling media not listed in the regulations.
·Public comment period: Both notices provide a 60-day public comment period, during which the public can submit feedback electronically or in writing.
According to the FDA website's announcement on August 22nd, the U.S. FDA has issued two notifications in the Federal Register, one regarding tobacco retailer training programs and the other seeking public input on regulations limiting tobacco sales.
Tobacco Retailer Training Program (Docket No. FDA-2025-N-2653)
The FDA is considering establishing standards to regulate tobacco retailer training programs. These programs should cover federal laws regarding the sale, advertising, and promotion of tobacco products, the health and economic impacts of tobacco use, and policies prohibiting sales to minors. The FDA estimates that around 239,100 tobacco retailers will need to develop training programs that comply with these guidelines. The program will also include requirements such as written tests, annual training updates, and record-keeping. The FDA projects that the annual burden of developing training programs, establishing written policies, and conducting internal compliance checks for information collection activities will be 1,992,500 hours, with a record-keeping burden of 191,280 hours.
Regulations restricting tobacco sales (Docket No. FDA-2025-N-2652)
The regulation aims to protect children and adolescents by restricting the sale and distribution of both traditional and smokeless tobacco products. It requires tobacco product manufacturers, distributors, and retailers to notify the FDA at least 30 days before using any advertising or labeling medium not specifically listed in the regulation. The FDA anticipates approximately four respondents to submit alternative advertising notifications each year, with an average burden of 1 hour per notification. Since 2022, the FDA has received a total of 12 such notifications.
Public Opinion Consultation
Both notices are in accordance with the Paperwork Reduction Act of 1995, which requires a 60-day period for public comment. The public can submit electronic comments through the Federal eRulemaking Portal website, or submit written comments through mail, hand delivery, or courier. For comments containing confidential information, two copies must be submitted - one with the confidential information included, and the other with the confidential information removed for public viewing. The FDA will assess and adjust information collection activities based on public feedback.
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