U.S. product recalls fell more than 10% in the third quarter of 2023, the largest quarterly decline recorded in over three years according to Sedgwick’s latest Recall Index report. Despite this decrease, 2023 still remains on track to hit a five-year…
After largely pausing onsite facility inspections during the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) has resumed this type of oversight in the past 18 months. However, several recent in-market events involving contaminated eye …
Frustration with the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) continues to mount among industry stakeholders over a lack of quick and economical regulatory approval processes. Since the inaction has resulted in s…
Responding to stakeholder concerns, the U.S. Food and Drug Administration (FDA) announced that it will establish a one-year stabilization period for the Drug Supply Chain Security Act (DSCSA) traceability requirements to ensure continuity of the supp…
In early August, the government of the United Kingdom released 13 proposals to change product safety. While stakeholders have been expecting these proposals for a while now, a few of the changes came as a surprise to regulatory experts because they c…
Artificial intelligence (AI) is everywhere, but it has largely been unregulated to this point. The European Union is looking to change that with its proposed EU AI Act. The European Parliament took a major step forward in AI regulation at the beginni…
The healthcare industry is changing to accommodate more modern demands, particularly those of patients who choose to self-treat. Over-the-counter (OTC) medications have risen in popularity recently, as patients increasingly seek more flexibility to t…
In a world of constant change and evolving challenges, risks are more interconnected than ever. Considering the speed at which news travels, the heavy focus on environmental, social and governance (ESG), and the daunting geopolitical environment, org…
The Consumer Products Safety Commission (CPSC) took a more aggressive enforcement stance in 2022, making it clear that companies needed to report any safety issues promptly or risk legal actions and steep fines. That approach is has continued in 2023…
The European Union’s “New Deal”, the Enforcement and Modernisation Directive, boosts consumer rights protection and updates e-commerce and digital content regulations. The directive also broadens the definition of product safety to include misleading…
As electrical OEMs congratulate themselves on a bumper year for sales, many remain cautious about what 2022 holds in store as new right to repair regulations start to bite. In some respects, 2021 has been a good year for electrical appliance manufa…
Benzene, which has been discovered in several consumer products over the past year, has once again forced a voluntary recall. This time, it’s related to dry shampoo and dry conditioner spray products from various household brands. The recall is prec…
Online pharmacy Valisure is warning that spray deodorants may be toxic to consumers — creating big problems and possible litigation threats to companies that aren’t paying attention. Valisure recently tested and detected unsafe levels of benzen…
The brave new world is here. The Consumer Product Safety Commission (CPSC) has issued its first report on artificial intelligence (AI) and machine learning (ML) in consumer products. The report promises added scrutiny of “potential hazards” created b…
Foreword by Jeremy Schutz, senior corporate sales manager at Sedgwick: Welcome to the latest edition of spotlight. This month, Carolyn W. Wagner at Crowell & Moring LLP shares her thoughts and opinions on the STURDY (Stop Tip-overs of Unstable, Risk…