FDA could take stronger enforcement action against tobacco retailers with histories of sales to youth and other violations

FDA could take stronger enforcement action against tobacco retailers with histories of sales to youth and other violations

Collection:
Health Policy and Services Research
Contributor(s):
United States. Department of Health and Human Services. Office of Inspector General. Office of Evaluation and Inspections, issuing body.
Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Language(s):
English
Format:
Text
Subject(s):
Government Regulation
Health Policy
Tobacco Control
Tobacco Industry -- legislation & jurisprudence
United States
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
Why OIG Did This Review. Youth tobacco use in the United States remains a high public health concern. The Food and Drug Administration’s (FDA’s) Tobacco Retailer Compliance Check Inspection Program is a critical part of its approach to prevent youth access to tobacco. Through that program, FDA inspects tobacco retailers to determine whether they are in violation of tobacco law or regulation. If FDA finds a violation, it may issue an advisory action, such as a warning letter, or an enforcement action, such as a civil money penalty (CMP). When FDA issues an enforcement action, it must consider mitigating factors including the nature, circumstances, extent, and gravity of the violation and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, and the degree of culpability. How OIG Did This Review. We analyzed data from FDA on retailer inspections; violations; and advisory and enforcement actions from 2010 through 2019. We also analyzed retailer inspection and violation histories for a random sample of retailers that were subject to enforcement actions. To determine whether FDA inspection, advisory, or enforcement actions varied by neighborhood socioeconomic characteristics, we compared FDA inspection data to the Area Deprivation Index. We also interviewed FDA officials about the agency’s direction and management of the Tobacco Retailer Compliance Check Inspection Program.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (43 pages))
Illustrations:
Illustrations
NLM Unique ID:
9918750682706676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918750682706676