Tobacco

FDA Begins Issuing Complaints Assessing Fines up to $5,000

Agency has issued civil money penalty complaints to 20 retailers

The FDA's Center for Tobacco Products has begun issuing "civil money penalty complaints," which are used to begin the agency's legal action against a retailer for alleged violations of federal tobacco regulations and can result in the assessment of a fine. The FDA's website lists 20 retailers that have been sent civil money penalty complaints for various alleged violations, including selling tobacco products to a minor; failing to verify the age of customers that are 27 years old or younger by requesting photo identification; having self-service displays of cigarettes, roll-your-own or smokeless tobacco products; failing to remove self-service displays from the store; and, for adult-only tobacco stores, failing to sell cigarettes and smokeless tobacco products in a direct face-to-face exchange, without ensuring that a minor is not present or permitted to enter the store at any time.

Of the 20 retailers cited in the FDA complaints, the agency is seeking to assess a $250 fine on six retailers, a $500 fine on 11 retailers and a $5,000 fine on three retailers. The retailers being cited with a $250 fine have been inspected by the FDA at least twice, and have two to three alleged tobacco regulation violations listed in the complaint. The retailers being cited with a $500 fine have been inspected at least twice, and have three to four alleged violations in the complaint. The three retailers being cited for a $5,000 fine have been inspected at least twice, and have six alleged violations in the complaint. The penalty structure being used by the FDA is as follows:

Number of Violations                                   Civil Money Penalty

1 violation                                                     $0

2 violations within 12 months                         $250

3 violations within 24 months                         $500

4 violations within 24 months                         $2,000

5 violations within 36 months                         $5,000

6 violations within 48 months                         $10,000      

Out of the 20 retailers cited with a complaint, 11 retailers responded to the FDA's warning letters that alleged retail violations while the other nine retailers did not respond in any manner to the FDA warning letters.   

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