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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 or surveillance activity for FY (1)

Measure implemented in September 2011

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 January 31, 2014

Fiscal Year - 2011

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Measure implemented in September 2011

TimeTargetNumber
Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/AN/A
Jan 2011N/AN/A
Feb 2011N/AN/A
Mar 2011N/AN/A
Apr 2011N/AN/A
May 2011N/AN/A
Jun 2011N/AN/A
Jul 2011N/AN/A
Aug 2011N/AN/A
Sep 2011N/A25

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 - 2011
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TimeTargetNumber
Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/AN/A
Jan 2011N/AN/A
Feb 2011N/AN/A
Mar 2011N/AN/A
Apr 2011N/AN/A
May 2011N/AN/A
Jun 2011N/AN/A
Jul 2011N/AN/A
Aug 2011N/AN/A
Sep 2011N/A1

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 - 2011
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TimeTargetNumber
Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/AN/A
Jan 2011N/AN/A
Feb 2011N/AN/A
Mar 2011N/AN/A
Apr 2011N/AN/A
May 2011N/AN/A
Jun 2011N/AN/A
Jul 2011N/AN/A
Aug 2011N/AN/A
Sep 2011N/A1

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.