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U.S. Department of Health and Human Services

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Cumulative number of regulatory and enforcement actions as a result of significant violations observed during an inspection, investigation, or surveillance activity for FY

Dictionary: The Family Smoking Prevention and Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act and provided the FDA with several enforcement tools to utilize when regulated industry fails to comply with the law. These tools include: warning letter, civil money penalty, no-tobacco-sale order, import alert, seizure, injunction, and criminal prosecution.

Information is current as of June 30, 2020

Fiscal Year - 2020

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TimeTargetNumber
Oct 2019N/A5
Nov 2019N/A12
Dec 2019N/A20
Jan 2020N/A29
Feb 2020N/A35
Mar 2020N/A53
Apr 2020N/A74
May 2020N/A94
Jun 2020N/A98
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 98

Footnotes

  • (1) Measure does not include regulatory and enforcement actions for those Retailers undergoing Compliance Check Inspections

Total number of regulatory and enforcement actions as a result of significant violations observed during an inspection, investigation, or surveillance activity in the quarter

Fiscal Year - 2020
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TimeTargetNumber
Oct 2019N/A5
Nov 2019N/A7
Dec 2019N/A8
Jan 2020N/A9
Feb 2020N/A6
Mar 2020N/A18
Apr 2020N/A21
May 2020N/A40
Jun 2020N/A44
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 158

Total number of Warning Letters issued as a result of significant violations observed during an inspection, investigation, or surveillance activity in the quarter

Warning Letters will generally be issued to other regulated tobacco product entities (e.g., manufacturers, distributors, importers, and Internet retailers), and generally excludes retailers undergoing compliance check inspections, the first time an inspection or surveillance activity reveals that they are not in compliance with tobacco product requirement. The Warning Letters are available in a searchable database on the agency’s website at www.fda.gov/ICECI/EnforcementActions/WarningLetters.

Fiscal Year - 2020
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TimeTargetNumber
Oct 2019N/A5
Nov 2019N/A7
Dec 2019N/A8
Jan 2020N/A9
Feb 2020N/A6
Mar 2020N/A18
Apr 2020N/A21
May 2020N/A40
Jun 2020N/A44
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 158

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.

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