Regulatory agencies are taking an increasingly aggressive stance on product safety to compel companies to address safety issues. The heightened scrutiny comes as product recall incidents across five major industries have ticked up in recent years.
According to Segdwick’s US recall index report, 2,454 product recalls were recorded in the automotive, consumer product, food and drink, medical device, and pharmaceutical industries year-to-date in 2024. If the pace of recalls continues in Q4, the annual figure will reach a six-year high.
Sedgwick experts said that navigating the evolving regulatory landscape, especially with changes like the recent US presidential election, will require close monitoring and adaptation by companies across these industries.
“We have seen strict regulatory scrutiny over the past several years, with agencies receiving criticism when they don’t seem to be doing enough,” said Chris Harvey (pictured), senior vice president of brand protection for Sedgwick. “However, the recent elections may result in weakened enforcement and rulemaking authority for regulators and a shift in priorities.”
As these changes take shape, industries must adapt to evolving standards while addressing emerging challenges in their respective sectors. For businesses, maintaining strong recall procedures and preparedness is vital.
In a recent product recall and safety webinar, Sedgwick gave an update on statistics for product recalls. According to Harvey, the total number of recalls across all industries decreased in the third quarter of 2024, with 755 recall events compared to 788 in Q2. Every sector experienced fewer recalls this quarter except for the medical device and USDA food sectors.
Year-to-date recall totals are relatively consistent with previous years, with 2,452 recalls in the first three quarters of 2024 compared to 2,459 during the same period in 2023.
The number of units recalled also fell significantly in Q3, decreasing nearly 23% from 254.5 million units in Q2 to 196.2 million this quarter. Several sectors, including medical devices, consumer products, and FDA food, reported fewer units impacted. Notably, FDA food saw its second-lowest number of recalled units since Q2 2021.
However, some exceptions stood out, Harvey said. “The automotive, pharmaceutical, and USDA food sectors all reported an increase in recalled units, with USDA food reaching its highest totals since Q3 2021,” he said. “Despite the decrease in Q3, the year-to-date total number of units recalled in 2024 remains higher than in 2023.”
In the third quarter of 2024, US regulators took significant steps across multiple industries, focusing on safety, transparency, and stricter enforcement. Here are the key updates according to Sedgwick’s report:
Policymakers ramped up efforts to strengthen the US automotive supply chain while improving regulatory oversight. The National Highway Traffic Safety Administration (NHTSA) finalized a rule requiring manufacturers to retain safety-related documents for 10 years, doubling the previous five-year requirement.
However, other safety technology measures have faced delays, with further action expected in 2025. These moves come as the average age of vehicles on US roads continues to rise, emphasizing the importance of safety and transparency in the sector.
The Consumer Product Safety Commission (CPSC) heightened its enforcement activities, taking unprecedented steps to protect consumers. For the first time, the agency issued a unilateral recall announcement when a seller of a defective product failed to cooperate with recall efforts. This aggressive approach builds on the CPSC’s increased reliance on public press releases to ensure compliance, signalling a long-term shift toward stricter oversight.
The Food and Drug Administration (FDA) launched its unified Human Foods Program in October, aiming to modernize its regulatory structure. Despite the adjustment period, the FDA has maintained its focus on ingredient contamination, with lead being a key concern.
At the same time, the USDA faced scrutiny after a Listeria-related deli meat recall raised questions about its inspection and enforcement protocols. The fallout from this incident is expected to impact the food industry for several quarters.
The FDA provided new guidance to medical device manufacturers, aiming to clarify regulatory expectations. Updated recommendations addressed how manufacturers can counter misinformation about their products online and detailed requirements for predetermined change control plans.
The agency also initiated stricter oversight of laboratory-developed tests (LDTs), though its new regulatory framework faces legal challenges that may shape its future enforcement.
In the pharmaceutical sector, the FDA partnered with the Federal Trade Commission (FTC) to crack down on misleading THC product marketing. Five companies received cease-and-desist letters for packaging that closely resembled popular food brands, raising concerns about products appealing to children.
Additionally, the FDA unveiled plans for its Rare Disease Innovation Hub, a new initiative to enhance collaboration and expedite drug and biologic approvals for rare diseases.
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