USA Law and Practice Contributed by: Trevor Keenan, Michelle Byers and Curtis Berglund, Campbell Conroy & O’Neil, P.C.
1.5 Penalties for Breach of Product Safety Obligations Penalties are set by law and imposed by agency or the US Department of Justice. CPSC Civil penalties are available if a company vio - lates laws enforced by the CPSC. The maximum amounts allowed are USD120,000 for each vio - lation, and USD17.15 million for any related series of violations. In November 2024, a wall bed manufacturer agreed to pay a USD16.025 million civil penalty for failing to report that its product could detach from the wall and create an unreasonable risk of serious injury to con - sumers. In January 2025, the CPSC provisionally accepted a settlement with a wearable device manufacturer for a USD12.25 million penalty for failing to report that the device could overheat and cause serious burns on consumers’ wrists. FAA The FAA may assess civil penalties up to USD400,000 against persons other than individ - uals and small businesses, and up to USD50,000 against individuals and small businesses, for violation of a law or statute enforced by the FAA. See 49 USC Section 46301; CFR Title 14, Section 13.18. Generally, the penalty for each violation ranges from USD1,100 to USD27,500, depending on the provision violated and the cat - egory of the alleged violator. FDA Civil and criminal penalties can be imposed on anyone who violates the FD&C. Civil penalties include warning letters, injunctions, seizure and civil fines. See 21 USC Sections 332, 334, 335b. Criminal penalties include imprisonment for up to one year, a fine of USD1,000, or both. See 21 USC Section 333 (a).
The FD&C also imposes enhanced criminal pen - alties for prescription drug marketing violations, violations related to medical devices, and distri - bution of human growth hormone. See 21 USC Sections 333 (b), 333 (e), 333 (f). Civil penalties can also be imposed by the FDA pursuant to CFR Title 21, Section 17 et seq, for failing to submit clinical trial information or submitting false or misleading information. The FDA is also authorised to impose civil penalties for violating the TCA. In September 2024, the FDA filed civil complaints against two brick and mortar retailers and nine online retailers for the sale of unauthorised tobacco products, seeking USD20,678 from each retailer. NHTSA The VSA provides for civil penalties of up to USD21,000 per violation, and up to USD105 mil - lion for a related series of violations. See 49 USC Section 30165. Submitting false or misleading reports exposes companies to civil penalties of USD5,000 per day, and up to USD1 million for a related series of violations. Criminal penalties for falsifying or withholding information include fines or imprisonment for up to 15 years, or both. In November 2024, the NHTSA announced a con - sent decree with a vehicle manufacturer for fail - ing to comply with federal recall requirements, which included a USD165 million penalty, the second-largest civil penalty in the NHTSA’s his -
tory. EPA
The EPA can impose civil penalties of up to USD37,500 for violating the TSCA, criminal fines and injunctions. See 15 USC Section 2615. Criminal penalties can include:
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