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U.S. Department of Health and Human Services

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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.

Fiscal Year - 2011

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TimeTargetNumber
Oct 2010N/A0
Nov 2010N/A0
Dec 2010N/A24
Jan 2011N/A42
Feb 2011N/A66
Mar 2011N/A114
Apr 2011N/A229
May 2011N/A358
Jun 2011N/A443
Jul 2011N/A544
Aug 2011N/A700
Sep 2011N/A1,019

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
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TimeTargetNumber
Oct 2010N/A0
Nov 2010N/A0
Dec 2010N/A24
Jan 2011N/A18
Feb 2011N/A24
Mar 2011N/A48
Apr 2011N/A115
May 2011N/A129
Jun 2011N/A85
Jul 2011N/A101
Aug 2011N/A156
Sep 2011N/A319

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.”

Fiscal Year - 2011

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Measure implementation began 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/A1

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
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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/A1

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.”

Fiscal Year - 2011

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Measure implemented September 2011

TimeTargetDollar
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/A0

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
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Measure implemented in September 2011

TimeTargetDollar
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/A0

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.