FDA Adjusts CMP Amounts for Tobacco Retailers

Yesterday, the FDA’s Center for Tobacco Products announced an amended fee structure for their Civil Monetary Penalties (CMP). CMPs are the scaled financial penalties FDA issued to retailers found in violation of current regulations or requirements.

A Civil Money Penalty (CMP) Complaint is used to initiate an administrative legal action against a retailer that can result in a monetary penalty, called a Civil Money Penalty.

The Tobacco Control Act provides that the amount of a CMP for violations of the regulations in part 1140 shall not exceed certain amounts, depending on the number of previous violations, the time period in which the violations occurred, and other factors (see section 103(q)(2)(A) of the Tobacco Control Act). The current maximum amounts are:

Number of Regulation Violations CMP Amount
1 $0 (CTP will send a Warning Letter)
2 within a 12-month period $285
3 within a 24-month period $570
4 within a 24-month period $2,282
5 within a 36-month period $5,705
6 within a 48-month period $11,410

Under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Pub. L. No. 114-74), HHS is required to adjust the amounts annually for inflation no later than January 15th each year. Read the rule, Adjustment of Civil Monetary Penalties for Inflation, for more information. See the Federal Register notice with the 2018 adjusted amounts.

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