About FDA

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
• All

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 - 2012

Time	Target	Number
Oct 2011	N/A	217
Nov 2011	N/A	254
Dec 2011	N/A	259
Jan 2012	N/A	242
Feb 2012	N/A	248
Mar 2012	N/A	182
Apr 2012	N/A	163
May 2012	N/A	TBD
Jun 2012	N/A	TBD
Jul 2012	N/A	TBD
Aug 2012	N/A	TBD
Sep 2012	N/A	TBD

FY 2012 YTD: 1,565

Cumulative number of Civil Money Penalties filed for the FY as a result of retailer compliance check inspections (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.

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)

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 - 2012

Time	Target	Number
Oct 2011	N/A	0
Nov 2011	N/A	1
Dec 2011	N/A	7
Jan 2012	N/A	21
Feb 2012	N/A	32
Mar 2012	N/A	41
Apr 2012	N/A	45
May 2012	N/A	TBD
Jun 2012	N/A	TBD
Jul 2012	N/A	TBD
Aug 2012	N/A	TBD
Sep 2012	N/A	TBD

FY 2012 Total: 147

Cumulative dollar amount of Civil Money Penalties Assessed 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.

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)

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 - 2012

Time	Target	Dollar
Oct 2011	N/A	0
Nov 2011	N/A	0
Dec 2011	N/A	1,500
Jan 2012	N/A	1,750
Feb 2012	N/A	5,225
Mar 2012	N/A	13,025
Apr 2012	N/A	10,400
May 2012	N/A	TBD
Jun 2012	N/A	TBD
Jul 2012	N/A	TBD
Aug 2012	N/A	TBD
Sep 2012	N/A	TBD

FY 2012 YTD: $31,900