In the wake of a significant recall of applesauce pouches, renewed attention has been drawn to the U.S. Food and Drug Administration’s (FDA’s) food contamination regulatory powers – or the lack thereof. In late October 2023, the FDA issued a safety …
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…
The number of European product recalls increased in the third quarter of 2023 for the fifth consecutive quarter, according to Sedgwick’s latest European Recall Index report. Across the five industries tracked in the report, there were 3,227 recalls i…
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 …
The U.S. Food and Drug Administration (FDA) continues to work through the redesign of its organizational structure into one unified Human Foods Program (HFP) and recently highlighted its dietary supplements program as a critical priority. In an upd…
On July 6, the U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released an updated list of draft and final guidance topics that will be a priority for the …
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…
According to Sedgwick’s 2023 State of the Nation Recall Index report, product recalls in five key European sectors increased in 2022 for the second consecutive year. The 10,545 recall events in 2022 represent a 4.3% increase over 2021 numbers for the…
Regulators in the United States have been moving especially quickly in the past year to implement new rules to protect children. With 2023 now well underway, companies should expect even more regulatory changes as federal agencies update their langua…
The Food and Drug Administration (FDA) came under harsh criticism this past year after a commercial infant shortage formula in the U.S. For months, Congress and parent advocacy groups have been pressuring the agency to investigate why this crisis eru…
The European Commission now seems to routinely extend the list of carcinogenic, mutagenic, or reprotoxic (“CMR”) substances that are prohibited for use in cosmetics throughout the EU. Most of these banned substances are relatively unknown, but a grow…
Foreword by Julie Ross, international business development director at Sedgwick: Welcome to the latest edition of spotlight. Spotlight is our way of sharing insights and perspectives from our strategic partners – lawyers, insurers, risk managers and…
Following a steady increase in reported deaths caused by faulty children’s products, the Consumer Product Safety Commission (CPSC) is under pressure to act more aggressively in pushing companies to recall products that pose a risk to children and tod…
As COVID-19 begins to subside, the U.S. Food and Drug Administration (FDA), like other federal agencies is shifting its focus away from the pandemic and back toward more routine issues. As an example, the FDA recently published its final guidance out…
Over the past few years, several drugmakers have had to recall blood pressure medications due to the presence of excess levels of nitrosamine. It’s happening again. Two major pharmaceutical companies have issued voluntary recalls of several tablet me…