- Docket Number:
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Guidance Issuing OfficeCenter for Tobacco Products
This guidance document is intended to assist retailers in implementing training programs for employees to learn about and comply with the Federal laws, including regulations, regarding:
- Sale and distribution of, including youth access to, tobacco products; and
- Advertising and promotion of cigarettes, smokeless tobacco, and covered tobacco products.
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31; 123 Stat. 1776) does not require retailers to implement retailer training programs. However, the statute does provide for lower civil money penalties for violations of access, sale, and distribution restrictions, advertising and promotion restrictions, and required warning statements promulgated under section 906(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, for retailers who have implemented a training program that complies with standards developed by FDA for such programs. FDA intends to promulgate regulations establishing standards for approved retailer training programs. In the interim, however, for retailers who wish to implement training programs, this guidance document explains:
- Recommendations for elements to be included in a retailer training program;
- Recommended hiring and management practices;
- The civil money penalties that may be assessed against retailers for violations of restrictions promulgated under section 906(d) of the FD&C Act, as amended by the Tobacco Control Act; and
- How the penalty structure differs for retailers with and without approved training programs.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2010-D-0350.