Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization (revised)

Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization (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 (United States. Food and Drug Administration), issuing body.
Publication:
Silver Spring, MD : Center for Tobacco Products, April 2020
Language(s):
English
Format:
Text
Subject(s):
Adolescent Behavior
Adolescent Health
Electronic Nicotine Delivery Systems
Vaping -- prevention & control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This guidance document describes how we intend to prioritize our enforcement resources with regard to the marketing of certain deemed tobacco products that do not have premarket authorization. For ENDS products marketed without FDA authorization, FDA intends to prioritize enforcement against: (1) Any flavored, cartridge-based ENDS product, (other than a tobacco- or menthol-based ENDS products); (2) All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minor's access, and; (3) Any ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors. Further, FDA intends to prioritize enforcement of any ENDS product that is offered for sale after September 9, 2020, and for which the manufacturer has not submitted a premarket application (or after a negative action by FDA on a timely submitted application). This guidance does not in any way alter the fact that it is illegal to market any new tobacco product without premarket authorization. FDA is continuously evaluating new information and adjusting its enforcement priorities in light of the best available data, and it will continue to do so with respect to these products. FDA will take appropriate action regarding tobacco products that are marketed without premarket authorization, including as warranted based on changed circumstances, new information, or to better address minors' use of those products.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (i, 51 pages)).
Edition:
Revision
NLM Unique ID:
9918227268206676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918227268206676