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GUIDANCE DOCUMENT

Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops Guidance for Industry March 2019

Final

Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops

Docket Number:
FDA-2017-D-0120
Issued by:
Guidance Issuing Office
Center for Tobacco Products

March 2019

This guidance document is intended to assist retailers who sell newly deemed products by explaining whether engaging in certain activities subjects such establishments to additional requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and identifying the limited circumstances under which FDA does not intend to enforce compliance. This guidance document discusses, among other things:

  • Definitions
  • FDA’s interpretation of and compliance policy for the label requirement in section 903(a)(2)(C) of the FD&C Act
  • Which vape shop activities subject vape shops to certain requirements of the FD&C Act
  • Limited circumstances under which FDA does not intend to enforce compliance

Submit Comments

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:

Division of Dockets Management (HFA- 305)
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-2017-D-0120.

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)