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
On July 9, 2025, the U.S. Food and Drug Administration (FDA) issued a letter from Commissioner for Human Foods Martin Makary and Deputy Commissioner for Human Foods Kyle Diamantas to industry members involved in the...more
As noted in our recent client alert, the U.S. Consumer Product Safety Commission (CPSC) continues to aggressively pursue enforcement actions for violations of the Consumer Product Safety Act (CPSA) against foreign...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
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
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
Years of adverse-event reports documenting problems associated with compromised food, dangerous drugs and harmful cosmetics are now available to the public. The information can be obtained, free of charge, via a downloadable...more
We do not get many court decisions in the CPSC world, but yesterday we received one. Last evening, a Wisconsin federal district court essentially held in the Government’s case against Spectrum Brands, Inc. (Spectrum) that...more
Air transportation of lithium ion batteries recently garnered significant attention due to events following reports of the Samsung Galaxy Note 7’s batteries overheating, catching fire, and even exploding. See Samsung Recalls...more
Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad. This situation presents an...more
Recently, Health Canada released guidance to help companies understand their reporting obligations under section 14 of the Canada Consumer Product Safety Act, which requires that sellers, distributors, importers, and...more
On Wednesday of last week, the Department of Justice (DOJ) and Consumer Product Safety Commission (CPSC) announced that a complaint has been filed in federal court against Spectrum Brands, Inc. (Spectrum). Notably, this is...more
Last week, the U.S. Department of Justice, on behalf of the United States Consumer Product Safety Commission (CPSC), filed suit against Michaels Stores, Inc. (“Michaels”) in the Northern District of Texas. United States of...more
On February 22, 2013, the U.S. Food and Drug Administration (FDA) released a long-anticipated draft guidance document entitled Distinguishing Medical Device Recalls from Product Enhancements; Reporting Requirements. With the...more