Compliance & Enforcement
FDA conducts compliance check inspections of tobacco product retailers to determine a retailer's compliance with federal laws and regulations, and generally issues Warning Letters for first-time violations. FDA generally issues civil money penalties for violations found on subsequent inspections.
Inspection Reports Database
Results from compliance check inspections covering cigarettes and smokeless tobacco products are available:
- Search the inspection database to find lists of retailer Warning Letters and Civil Money Penalty Complaints issued by FDA and a list of inspected establishments where no violations were observed.
- The establishments where Compliance Check Inspections have been completed will be displayed as pins on a map, based on the search results. Information regarding the specific Compliance Check Inspections can be viewed by zooming in and selecting the individual pins.
- Search by tobacco retailer name, city, state, zip code, and decision date.
A Warning Letter is the agency’s advisory action that is used to achieve prompt voluntary compliance with the law. FDA generally issues Warning Letters, displayed in a searchable database, to tobacco retailers generally the first time violations are observed during a compliance check inspection.
Find all other Warning Letters issued by CTP at FDA’s main Warning Letters page.
Civil Money Penalty Complaints
A Civil Money Penalty (CMP) Complaint is used to initiate an administrative legal action against a retailer that can result in the imposition of a fine, called a Civil Money Penalty.
FDA generally issues Civil Money Penalty Complaints, displayed in a searchable database, to tobacco retailers when subsequent violations are observed during a compliance check inspection.
Civil Money Penalty Complaints issued during the past 45 days can be downloaded below. Earlier Complaints can be found in the searchable database.
Federal Laws and Regulations
Compliance check inspections determine a retailer's compliance with, among other things:
- The Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act.
- The Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, found at Title 21 of the Code of Federal Regulations, Part 1140 (21 C.F.R. Part 1140).