The U.S. Food and Drug Administration has issued an updated final guidance document that describes civil penalty procedures involving violations of federal regulations for retail tobacco sales. The guidance is written in a question and answer format and explains the agency’s process of issuing fines to retailers that violate federal tobacco regulations. The guidance also explains the rights of retailers to respond to and appeal a civil penalty or fine.
FDA ISSUES NEW Q & A GUIDANCE FOR RETAILERS ON TOBACCO RELATED VIOLATIONS
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) issued a new guidance document, “Civil Money Penalties for Tobacco Retailers: Answers to Frequently Asked Questions” designed to inform retailers of the process the agency uses when issuing violations related to tobacco product sales under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 et seq.). In particular, the guidance provides information about CTP’s enforcement of the requirement that tobacco products may not be sold or distributed in violation of FDA’s regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents (21 CFR part 1140).
According to the guidance, the FDA initiates the civil penalty process by issuing a letter of complaint, explaining the specific violation that the agency alleges the retailer committed. The retailer may respond by paying the fine or appealing the violation by submitting a formal answer to the complaint. Once an answer is filed, the retailer may enter settlement negotiations with the FDA or proceed to a formal hearing before an impartial administrative law judge. The guidance explains the step by step process retailers must follow to appeal a civil penalty issued by the FDA. The guidance also includes the following civil penalty schedule:
- First violation involves a warning letter; no fine.
- Second violation within a 12-month period carries a $250 fine.
- Third violation within a 24-month period carries a $500 fine.
- Fourth violation within a 24-month period carries a $2,000 fine.
- Fifth violation within a 36-month period carries a $5,000 fine.
- Sixth or subsequent violation within a 48-month period carries a $10,000 fine.
The FDA’s new guidance document, “Civil Money Penalties for Tobacco Retailers: Answers to Frequently Asked Questions” may be viewed here.