USA Law and Practice Contributed by: Trevor Keenan, Michelle Byers Graham and Curtis Berglund, Campbell Conroy & O’Neil, P.C.
ing serious injury or death. See CFR Title 21, Section 803.40 (b). Reporting requirements are set forth in CFR Title 21, Sections 803.42, 803.52. Manufacturers are also required to report within five days events requiring remedial action to prevent an unreasonable risk of substantial harm to public health. See CFR Title 21, Section 803.53. NHTSA The NHTSA requires risk-based and incident-based reporting. Vehicle and equipment manufacturers must submit a Defect and Non-Compliance Information Report to the NHTSA within five working days of concluding that the equipment or vehicle poses a danger or fails to comply with FMVSS. Information required in the report is set forth in CFR Title 49, Section 573.6. Pursuant to CFR Title 49, Section 579.11, manufacturers must inform the NHTSA of safety recalls or campaigns in foreign countries within five days of deciding to conduct the recall or receiving notice from a foreign government that action is required. The TREAD Act requires vehicle and equipment man - ufacturers to report periodically to the NHTSA on a variety of information that could indicate the existence of a potential product safety defect, and to advise the NHTSA of safety recalls or campaigns in foreign countries. Pursuant to 49 USC Section 30166 (f), manufacturers are required to submit to the NHTSA copies of their communications about defects and non-compliance with FMVSS. 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 violates laws enforced by the CPSC. The maximum amounts allowed are USD120,000 for each violation, and USD17.15 million for any related series of violations. In January 2026, a chemical manufacturer agreed to pay a USD14.15 million civil penalty for knowingly failing
to report that its cleaning products contained bacterial contamination which could create a substantial risk of infection for some consumers. In March 2026, a bicy - cle manufacturer agreed to pay a USD11.5 million civil penalty for knowingly failing to immediately report that its cranksets contained a defect which could create a substantial product hazard or an unreasonable risk of serious injury or death to consumers. FAA The FAA may assess civil penalties up to USD1.2 mil - lion against persons other than individuals and small businesses, and up to USD100,000 against individu - als and small businesses, for violation of a law or stat- ute 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 USD75,000, depending on the provision violated and the category 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 penalties for prescription drug marketing violations, violations related to medical devices, and distribution of human growth hormone. See 21 USC Sections 333 (b), 333 (e), 333 (f). Civil penalties can also be imposed by the FDA pur - suant 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. NHTSA The VSA provides for civil penalties of up to USD27,874 per violation, and up to USD139,356,994 for a related series of violations. See CFR Section 578.6. Submit - ting false or misleading reports exposes companies to civil penalties of USD6,823 per day, and up to USD1,364,624 for a related series of violations. Crimi - nal penalties for falsifying or withholding information
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