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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 September 30, 2012

• FY 2011
• FY 2012
• FY 2013
• All

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

Time	Target	Number
Oct 2010	N/A	N/A
Nov 2010	N/A	N/A
Dec 2010	N/A	N/A
Jan 2011	N/A	N/A
Feb 2011	N/A	N/A
Mar 2011	N/A	N/A
Apr 2011	N/A	N/A
May 2011	N/A	N/A
Jun 2011	N/A	N/A
Jul 2011	N/A	N/A
Aug 2011	N/A	N/A
Sep 2011	N/A	1

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

Time	Target	Number
Oct 2010	N/A	N/A
Nov 2010	N/A	N/A
Dec 2010	N/A	N/A
Jan 2011	N/A	N/A
Feb 2011	N/A	N/A
Mar 2011	N/A	N/A
Apr 2011	N/A	N/A
May 2011	N/A	N/A
Jun 2011	N/A	N/A
Jul 2011	N/A	N/A
Aug 2011	N/A	N/A
Sep 2011	N/A	1