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U.S. Department of Health and Human Services

About FDA

Cumulative number of regulatory and enforcement actions as a result of significant violations observed during an inspection or surveillance activity for FY (1)

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 March 31, 2014

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A6
Nov 2012N/A10
Dec 2012N/A11
Jan 2013N/A20
Feb 2013N/A21
Mar 2013N/A27
Apr 2013N/A41
May 2013N/A44
Jun 2013N/A45
Jul 2013N/A51
Aug 2013N/A54
Sep 2013N/A60

FY 2013 Cumulative Total: 60

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 or surveillance activity in the month

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A6
Nov 2012N/A4
Dec 2012N/A1
Jan 2013N/A9
Feb 2013N/A1
Mar 2013N/A6
Apr 2013N/A14
May 2013N/A3
Jun 2013N/A1
Jul 2013N/A6
Aug 2013N/A3
Sep 2013N/A6

FY 2013 Total: 60

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

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 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A6
Nov 2012N/A4
Dec 2012N/A1
Jan 2013N/A9
Feb 2013N/A1
Mar 2013N/A6
Apr 2013N/A14
May 2013N/A3
Jun 2013N/A1
Jul 2013N/A6
Aug 2013N/A3
Sep 2013N/A6

FY 2013 Total: 60

Glossary

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.