Tobacco Products
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 in states with FDA tobacco enforcement contracts.
- Search by tobacco retailer name, city, state, zip code, and decision date.
Absence of a retail establishment from this list does not imply compliance with all applicable statutory and regulatory requirements.
Retailers play a role in protecting the health of America’s youth by not selling, marketing, or advertising cigarettes or smokeless tobacco products to underage children and adolescents.
Tobacco use causes more than 400,000 deaths each year, and, because a large majority of Americans start smoking before reaching the age of 18, many of these deaths can be prevented by discouraging young people from initiating tobacco use.
Warning Letters
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).