The Food and Drug Administration needs to improve the premarket tobacco application review process for electronic nicotine delivery systems to protect public health
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Department of Health and Human Services. Office of Inspector General. Office of Audit Services, issuing body.
- Publication:
- [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, November 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Electronic Nicotine Delivery Systems -- supply & distribution Government Regulation Tobacco Control -- legislation & jurisprudence United States United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- Why OIG Did This Audit. Use of e-cigarettes by youth remains a public health issue that is affecting children, families, schools, and communities. In July of 2019, a U.S. District court issued an order directing the Food and Drug Administration (FDA) to require that premarket tobacco product applications (PMTAs) be submitted for all new deemed tobacco products; otherwise, they are subject to the FDA’s enforcement actions. By the September 9, 2020, deadline, FDA’s Center for Tobacco Products (CTP) received PMTAs for more than 6 million electronic nicotine delivery systems (ENDS) products. Our objectives were to determine (1) FDA’s progress on reviewing applications for ENDS products; (2) whether FDA followed Federal statutes, regulations, policies, and guidance when granting or denying ENDS products; and (3) what actions FDA has taken to ensure that ENDS products that are not appropriate for the protection of public health are kept off the market. How OIG Did This Audit. Our audit covered the PMTAs submitted to CTP from August 1, 2019, through September 9, 2020. To accomplish our audit objectives, we reviewed applicable Federal and program requirements, interviewed CTP officials, and reviewed the submission documents and CTP work products of a judgmental sample of ENDS products for which a PMTA was submitted.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (24 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918750687006676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918750687006676