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GUIDANCE DOCUMENT

Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents Guidance for Industry August 2013

Final

This guidance is being distributed for comment purposes only.

Issued by:
Guidance Issuing Office
Center for Tobacco Products

August 2013

This guidance is intended to assist manufacturers, distributors, retailers, and others who sell cigarettes and/or smokeless tobacco in understanding the final Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents and to explain what you should do in order to comply with the regulations. The document explains, among other things:

  • what and who are subject to the regulations;
  • prohibition on the sale and distribution of certain tobacco products to persons younger than 18 years of age;
  • restrictions on access, which consist largely of requirements concerning the sale of cigarettes and smokeless tobacco; and
  • labeling and advertising restrictions

The regulations currently apply to cigarettes, including roll-your-own tobacco; cigarette tobacco; and smokeless tobacco products (e.g., moist snuff, snus, dry snuff, nasal snuff, loose leaf chewing tobacco, plug chewing tobacco, and twist chewing tobacco).

FDA’s guidances, 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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
Contact CTP
Document Control Center
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Ave WO71-G335
Silver Spring, MD 20993-002
AskCTP@fda.hhs.gov
(877) 287-1373 (9am EST-4pm EST)