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Cumulative number of Warning Letters issued in the month as a result of retailer compliance check inspections for the FY (excluding internet based)

Dictionary: The Family Smoking Prevention and Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act and provided the FDA with a broad set of sanctions for violations of the law. Such sanctions may include: warning letter, civil money penalty, import alert, seizure, injunction, and criminal prosecution.

Warning Letters are issued to tobacco product retailers not in compliance with tobacco product requirements and are available in a searchable database on the agency’s website at Inspections, Compliance, Enforcement, and Criminal Investigations-Warning Letters. This database is updated weekly.

• FY 2011
• FY 2012
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Number of Warning Letters issued in the month as a result of retailer compliance check inspections (excluding internet based)

The Family Smoking Prevention and Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act and provided the FDA with a broad set of sanctions for violations of the law. Such sanctions may include: warning letter, civil money penalty, import alert, seizure, injunction, and criminal prosecution.

Warning Letters are issued to tobacco product retailers not in compliance with tobacco product requirements and are available in a searchable database on the agency’s website at Inspections, Compliance, Enforcement, and Criminal Investigations-Warning Letters. This database is updated weekly.

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	0
Nov 2010	N/A	0
Dec 2010	N/A	24
Jan 2011	N/A	18
Feb 2011	N/A	24
Mar 2011	N/A	48
Apr 2011	N/A	115
May 2011	N/A	129
Jun 2011	N/A	85
Jul 2011	N/A	101
Aug 2011	N/A	156
Sep 2011	N/A	319

FY 2011 Total: 1,019

Cumulative number of Civil Money Penalties filed for the FY as a result of retailer compliance check inspections (excluding internet based)

Measure implementation began 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 a broad set of sanctions for violations of the law. Such sanctions may include: warning letter, civil money penalty, import alert, seizure, injunction, and criminal prosecution.

Civil Money Penalties are assessed against tobacco product retailers not in compliance with tobacco product requirements. For more information about the agency’s current policies with respect to civil money penalties for retailers who are in violation, please see CTP’s website Guidance, Compliance & Regulatory Information, to find the guidance entitled, “Guidance for FDA and Tobacco Retailers Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers.”

Number of Civil Money Penalties filed in the month as a result of retailer compliance check inspections (excluding internet based)

Measure implemented in September 2011

The Family Smoking Prevention and Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act and provided the FDA with a broad set of sanctions for violations of the law. Such sanctions may include: warning letter, civil money penalty, import alert, seizure, injunction, and criminal prosecution.

Civil Money Penalties are assessed against tobacco product retailers not in compliance with tobacco product requirements. For more information about the agency’s current policies with respect to civil money penalties for retailers who are in violation, please see CTP’s website Guidance, Compliance & Regulatory Information, to find the guidance entitled, “Guidance for FDA and Tobacco Retailers Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers.”

Fiscal Year - 2011

Measure implemented in September 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

Cumulative dollar amount of Civil Money Penalties Assessed for the FY (excluding internet based)

Measure implemented September 2011

Dictionary: The Family Smoking Prevention and Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act and provided the FDA with a broad set of sanctions for violations of the law. Such sanctions may include: warning letter, civil money penalty, import alert, seizure, injunction, and criminal prosecution.

Civil Money Penalties are assessed against tobacco product retailers not in compliance with tobacco product requirements. For more information about the agency’s current policies with respect to civil money penalties for retailers who are in violation, please see CTP’s website Guidance, Compliance & Regulatory Information, to find the guidance entitled, “Guidance for FDA and Tobacco Retailers Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers.”

Total dollar amount of Civil Money Penalties as a result of retailer compliance check inspections assessed in the month (excluding internet based)

Measure implemented in September 2011

The Family Smoking Prevention and Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act and provided the FDA with a broad set of sanctions for violations of the law. Such sanctions may include: warning letter, civil money penalty, import alert, seizure, injunction, and criminal prosecution.

Civil Money Penalties are assessed against tobacco product retailers not in compliance with tobacco product requirements. For more information about the agency’s current policies with respect to civil money penalties for retailers who are in violation, please see CTP’s website Guidance, Compliance & Regulatory Information, to find the guidance entitled, “Guidance for FDA and Tobacco Retailers Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers.”

Fiscal Year - 2011

Measure implemented in September 2011

Time	Target	Dollar
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	0