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Submission of plans for cigarette packages and cigarette advertisements (revised)
Submission of plans for cigarette packages and cigarette advertisements (revised)
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Tobacco Products (U.S.), issuing body. - Publication:
- Silver Spring, MD : Center for Tobacco Products, July 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Cigarette Smoking -- adverse effects
Cigarette Smoking -- prevention & control
Product Packaging
Tobacco Products -- adverse effects
Tobacco Products -- supply & distribution
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration - Genre(s):
- Technical Report
- Abstract:
- FDA (Agency, we) is issuing this guidance to assist persons (you) submitting cigarette plans2 for cigarette packages and cigarette advertisements, as required by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31), amending the Federal Cigarette Labeling and Advertising Act (FCLAA) (15 U.S.C. 1333). This guidance provides recommendations related to 21 CFR 1141 and the FCLAA requirements regarding the submission of cigarette plans for cigarette packages and advertisements. This guidance document also discusses, among other things: (1) The regulatory requirements to submit cigarette plans (2) Definitions (3) Who submits a cigarette plan (4) The scope of a cigarette plan (5) When to submit a cigarette plan (6) What information should be submitted as part of a cigarette plan (7) Where to submit a cigarette plan (6) What approval of a cigarette plan means. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, 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.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (27 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918231298406676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918231298406676