Ad Law Tool Kit Show – Episode 1 – Product Safety and Recalls
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more
Consumer product companies are facing unprecedented scrutiny as the Consumer Product Safety Commission (CPSC) intensifies its regulatory oversight. With heightened civil penalties, increased monitoring of e-commerce...more
Share on Twitter Print Share by Email Share Back to top Over the past year, manufacturers, importers, distributors, and retailers of consumer products containing button cell and coin batteries (or products intended to contain...more
The consumer-packaged goods and restaurant industries play a crucial role in the global food supply chain, providing a wide variety of food options that consumers rely on for their daily nourishment. However, the integrity of...more
In recent years, the Consumer Product Safety Commission (CPSC) has increased pressure on consumer product companies through various enforcement mechanisms. The increase in the frequency and amount of civil penalties sought by...more
Since the fall 2023, the United States has been facing a massive recall of apple cinnamon fruit purees (like apple sauce) due to the presence of elevated levels of lead which caused the product to be considered adulterated...more
Conducting a recall is a time-sensitive process that requires an informed, strategic, and measured approach. When conducting recalls, companies must take the necessary steps to protect patients or consumers and comply with...more
As we have reported at length, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposed extensive new requirements related to cosmetic products marketed in the United States. As compliance deadlines for these new...more
On January 5, 2023, the Consumer Product Safety Commission (CPSC) reported Peloton agreed to pay a $19,065,000 civil penalty as a settlement regarding its Tread+ treadmill, approximately a year and a half after the CPSC and...more
Now is the time for businesses to spring clean their Product Safety Incident Plan, create a new Product Safety Management Plan and review their pre-market product safety compliance procedures in light of several new and...more
Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more
When unraveling a major corporate scandal, especially multi-year schemes involving senior executives, the blame game or lessons learned approach can easily turn into a fruitless exercise. The VA and Takata scandals are...more
The creator of one of the most ubiquitous symbols of mid-century Americana died earlier this week. Don Featherstone, the creator of the pink plastic lawn flamingo, the ultimate symbol of American lawn kitsch, has died. He was...more
In a press release issued on September 17, 2014, the U.S. Consumer Product Safety Commission (CPSC) announced that Michigan-based retailer, Meijer Inc., will pay a $2 million dollar fine to resolve allegations that it...more
The CPSC is considering whether to issue an interpretative rule (to be included as part of 16 CFR 1115) that would significantly alter the way in which voluntary recalls and corrective action plans (CAPs) are conducted. One...more
A unanimous U.S. Consumer Product Safety Commission (“CPSC”) announced that Ross Stores Inc. (“Ross”), a national discount retailer, agreed to pay a $3.9 million civil penalty to settle allegations that it failed to report...more