Notification requirements

Criteria for notification

What events or conditions trigger a requirement to notify the product safety authorities of issues discovered in products, or known incidents of personal injury or property damage?

Section 15(b) of the Consumer Product Safety Act (CPSA) establishes reporting requirements for manufacturers, importers, distributers and retailers of consumer products. Those entities must report to the Consumer Product Safety Commission (CPSC) immediately, or within 24 hours, upon receiving information that reasonably supports a conclusion that their product fails to comply with applicable law or regulations, contains a defect that could create a substantial hazard to consumers or creates an unreasonable risk of serious injury or death. Information giving rise to a reporting obligation may include complaints, claims for damage, injury or incident reports, quality control, production and engineering data, safety-related production or design changes and requests for returns, replacements or credit.

The Food and Drug Administration (FDA) has promulgated different reporting requirements depending on the specific type of product at issue. For example, manufacturers of medical products must report to FDA immediately upon learning that a medical product has caused or contributed to death or serious injury or upon becoming aware that a product has malfunctioned and is likely to result in fatality or serious injury.

Similarly, drugs and supplements that give rise to a serious adverse event or an event that results in death, disability, birth defects or requires medical attention to prevent those results must be reported to FDA no later than 15 days after learning of the event. Federal law requires that facilities that manufacture or label food products notify FDA as soon as practicable, but no later than 24 hours, upon learning that an article of food is ‘reportable’ (ie, reasonably probable to cause serious adverse health effects or death to humans or animals).

Medical device manufacturers and importers are required to report a correction or removal of a medical device if it involves a ‘risk to health’ as defined by FDA regulation. The report must be submitted to FDA within 10 working days of the date when the company ‘initiates’ (as interpreted by FDA) the correction or removal of the medical device. If there a risk to health is not involved in the correction or removal, a report to FDA is not required, but the manufacturer or importer must maintain records of the recall (correction or removal).

The Federal Motor Vehicle Safety Act requires a manufacturer to submit a defect and non-compliance information report to the National Highway Traffic Safety Administration (NHTSA) no more than five days after determining its vehicle or equipment is defective or non-compliant with a motor vehicle safety standard. Manufactures must also notify by mail the owners, purchasers and dealers of the product at issue.

Competent authority for notification

To which authority should notification be sent? Does this vary according to the product in question?

The federal authority to which notice must be sent varies depending on the type of product at issue. Generally, notice should be sent to the agency that regulates the specific product. Notifications relating to consumer products should be sent to the CPSA, notices relating to food, drugs and medical devices should be sent to FDA, and notices relating to motor vehicles should be sent to NHTSA.

Obligations to provide updates after initial notification

What obligations are there to provide authorities with updated information about risks, or respond to their enquiries following an initial notification?

The CPSA, FDA and NHTSA each require parties to submit updated information after initial notification.

The CPSA requires companies to provide a monthly progress report for a corrective action plan (CAP) that identifies the products corrected and captured by the company during the reporting period, the notification measures used during the reporting period, any consumer feedback and a listing of the number of consumer contacts made to the company via toll-free numbers, emails, social media, written requests and website visits. The CPSC reviews the reports to assess the effectiveness of the CAP and to identify additional measures to be taken by the company if the CAP is not meeting the goals of a recall, that is, to retrieve, repair or replace affected products.

NHTSA similarly requires that manufacturers recalling vehicles or automobile parts submit quarterly recall reports pursuant to 49 CFR 573.7. The recall reports should be submitted for six consecutive quarters, starting with the quarter in which the campaign was initiated or after a corrective action has been completed on all defective or non-complying vehicles or items, whichever occurs first.

Finally, FDA can request recall status reports from a recalling entity every two to four weeks to monitor and assess the progress of the recall. Recall status reports include the number of consumers notified of the recall, the number of products returned or corrected and the time frame for completion of the recall.

Penalties for failure to notify

What are the penalties for failure to comply with notification obligations?

Most agencies have authority to issue civil and criminal penalties to entities that fail to undertake a recall or other corrective action and have authority to seize and detain offending products. For instance, FDA may seek civil monetary or criminal penalties under certain circumstances related to the failure to recall a product or the failure to comply with FDA requirements. FDA can also seize a product because it is adulterated or misbranded and may seek injunctions against individuals and corporations to prevent them from violating or causing violations of the federal laws overseen by FDA or to force them to conduct a recall.

Similarly, the Food Safety and Inspection Service has the legal authority to detain and seize products that may be adulterated, misbranded or otherwise in violation of the law if a company refuses to voluntarily recall those products.

The CPSA likewise authorises the Commission to impose civil penalties for failure to comply with a recall or exporting a product that is subject to a voluntary or court-ordered recall in the United States. Civil penalties for those offences are US$120,000 for each violation, with a maximum civil penalty of US$17.15 million. The CPSA also makes it unlawful to sell recalled products and subjects offenders to criminal enforcement.  

Public disclosure of notification information

Is the content of the notification publicly disclosed by the authorities? Is commercially sensitive information contained in the notification protected from public disclosure, or are the authorities otherwise bound by confidentiality?

The CPSC, FDA and NHTSA all maintain databases of recall information on their websites. Additionally, the content of notifications and reports is generally subject to public disclosure pursuant to the Freedom of Information Act (FOIA), which allows consumers to access government-controlled information; however, not all the information in the reports is subject to disclosure, and companies may object to the disclosure of certain information if it is confidential, inaccurate or misleading.

The CPSA generally authorises the CPSC to publicly release the information in reports and notifications, with the exception of confidential information and trade secrets. Before releasing any non-proprietary information to the public, the CPSC must first notify the company, provide a summary of the information to be disclosed and provide the company with an opportunity to object.

The Federal Food, Drug and Cosmetic Act similarly prohibits disclosure of trade secrets and confidential commercial information. Companies submitting reports to FDA may designate part of or all the information as exempt from disclosure under FOIA, subject to FDA review.  

Use of information in prosecution

May information notified to the authorities be used in a criminal prosecution?

The relevant statutes generally do not distinguish between civil and criminal proceedings in respect of disclosure of information. Section 37 of the CPSA requires manufacturers to report certain information about settled or adjudicated lawsuits within 30 days of the settlement or judgment.

The Commission has authority under the CPSA to disclose information reported pursuant to section 37, or information pertaining to settled or adjudicated lawsuits, in legal actions it brings against manufacturers for non-compliance with section 37. 

Information sharing between regulators

Is notification information shared with other regulators?

While the information disclosed in a report under section 37 of the CPSA is not usually subject to public disclosure, the Commission may furnish such reports to Congress upon a written request. FDA uses information sharing agreements to share non-public information with state and local government officials when necessary.

US federal agencies may also share information, such as product safety standards and bans with foreign governments and international partners, as part of international coordination efforts regarding product safety. It is FDA practice to execute cooperative arrangements with foreign entities, and it may share non-public information pursuant to a legal confidentiality agreement.