The U.S. Food and Drug Administration (FDA) filed a pair of public inspection documents scheduled to be published tomorrow (August 22) regarding the regulations surrounding children and adolescents purchasing tobacco and nicotine products, and the marketing and labeling of such products. The documents will each open a 60-day public comment period under the Paperwork Reduction Act.
The first guidance, document 2025-16068, focuses on tobacco retailer training programs, detailing recommended elements that would include federal law requirements restricting access to, and the marketing and promotion of, covered tobacco and nicotine products. It would also focus on company policies, age verification methods, practical refusal techniques, and the health risks associated with tobacco use.
The FDA would advise retailers to require employees to pass written tests before selling tobacco products, with refresher training held at least annually, and to keep such training records for four years to demonstrate compliance. The guidance also encourages strong hiring and management practices, such as informing staff of youth access laws, conducting internal compliance checks, and documenting corrective actions.
“We assume that 75% of tobacco retailers already have some sort of age and identification verification training program in place,” the filing made by Grace R. Graham, deputy commissioner for Policy, Legislation, and International Affairs, said. “We expect that some of those retailer training programs already meet the elements in the guidance, some retailers would update their training program to meet the elements in the guidance, and other retailers would develop a training program for the first time. Thus, we estimate that two-thirds of tobacco retailers would develop a training program that meets the elements in the guidance.”
FDA estimates the proposal will affect about 79,700 retailers nationwide, creating an annual reporting burden of nearly 2 million hours, plus over 191,000 hours for recordkeeping.
The second guidance, document 2025-16067, reminds tobacco companies of their obligation to notify the agency before using new advertising or labeling formats for cigarettes and smokeless tobacco. The requirement, authorized under the Federal Food, Drug, and Cosmetic Act, aims to ensure compliance with restrictions on tobacco marketing and promotion.
Under federal regulations (21 CFR part 1140), manufacturers, distributors, and retailers of cigarettes or smokeless tobacco must submit notice to FDA at least 30 days in advance if they plan to use a form of advertising or labeling that is not already permitted, such as where newspapers, magazines, billboards, point-of-sale materials, and direct mail are permissible.
Comments can be made for either guidance online at www.regulations.gov, or mailed to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.