The FDA has announced an increase in the monetary fines that are accessed against retailers that violate federal tobacco regulations. These increases were made according to the Federal Civil Penalties Inflation Adjustment Act of 2015, which allows each federal agency to adjust its monetary fines for inflation once a year.
Under the terms of this new federal law, the FDA was not required to issue a proposed rule adopting the inflation adjusted monetary fines. The FDA’s new monetary fine amounts apply to retailers assessed with a fine by the agency after Aug. 1, 2016, even if the retail violation or violations occurred as far back as Nov. 2, 2015.
The number of violations, previous fine amounts and new fine amounts are as follows:
| Number of violations | Previous fine amount | New fine amount |
|---|---|---|
| 1 | $0 with a warning letter | $0 with a warning letter |
| 2 within a 12-month period | $250 | $275 |
| 3 within a 24-month period | $500 | $550 |
| 4 within a 24-month period | $2,000 | $2,200 |
| 5 within a 36-month period | $5,000 | $5,501 |
| 6 within a 48-month period | $10,000 | $11,002 |
The new penalty amounts equal a 10% increase over the previous levels of fines the FDA could assess against a retailer. Moreover, if a retailer is cited with more than six violations, the FDA has the right to pursue a “no tobacco sales order” that prohibits the retailer from selling tobacco products for a specific period of time.
The FDA has been conducting retail compliance inspections since 2010. The Family Smoking Prevention and Tobacco Control Act, the law that authorized the FDA to regulate tobacco products, mandates that the FDA contract with state government agencies or other firms to conduct regular compliance checks on retailers. The agency is now conducting retail compliance checks in all 50 states.
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