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
Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...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
On May 15, 2025, the Consumer Product Safety Commission (CPSC or Commission) announced a “record-breaking week” of enforcement actions against “foreign violators.”[1] Namely, the Commission announced 28 separate product...more
On March 14, 2025, Amazon filed suit against the Consumer Product Safety Commission (CPSC) in the U.S. District Court for the District of Maryland, challenging CPSC’s July 29, 2024, and January 16, 2025, orders determining...more
This second installment of our series highlights the Consumer Product Safety Commission’s (CPSC) presence and guidance at this year’s ICPHSO annual symposium. CPSC had a notably smaller presence this year. Agency...more
On December 19, 2024, the Consumer Product Safety Commission (CPSC) unilaterally issued a warning to consumers to stop using Sport Nets 4’ x 8’ portable soccer goals. According to CPSC, an exposed metal tip at the top of the...more
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
Earlier this year, the US Center for Disease Control and Prevention (“CDC”) spotted an outbreak of a rare bacterial infection in 11 (now 16) different states, associated with multiple different infection types, particularly...more
As 2022 came to a close, the U.S. Consumer Product Safety Commission (CPSC) had one last order of business. On December 28, 2022, the CPSC provisionally accepted a settlement agreement with Peloton Interactive, Inc....more
In recent months, the Food and Drug Administration (FDA) announced several recalls related to natural supplements that were found to contain tadalafil and its analogs, the active ingredients in Viagra and Cialis. In its...more
On May 16, President Biden signed the Safe Sleep for Babies Act into law, less than two weeks after being passed by Congress. The Act addresses the controversy around inclined sleepers and crib bumpers for infants by banning...more
Manufacturer Has Ceased Sales and Issued Urgent Letter Warning Physicians to “Stop Using” Unused Implants - Medtronic, the manufacturer of a medical implant that is alleged to have led to more than a dozen deaths,...more
More aggressive enforcement actions and increased regulatory activities under the Biden Administration are here. In President Biden’s first weeks, he is making good on his promise to reverse course from the previous...more
A comprehensive guide to the latest developments affecting non-prescription drug products under Monograph Reform. American Conference Institute’s Advanced Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs will...more
Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year....more
Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more
A last-minute deal between defendants McKesson, Cardinal Health, AmerisourceBergen, and Teva and plaintiffs’ attorneys means that multidistrict opioid epidemic litigation set to kick off in Ohio federal court today will not...more
On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc. had initiated a recall for the Visibly Online Refractive Vision Test, a software application offered...more
Recent FDA Recall Highlights & Developments - • The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more
On Monday, June 11, 2018, a Colorado District Court Judge tossed a U.S. Consumer Product Safety Commission’s recall order on due process grounds. The Court found that Commissioner Robert Adler’s previous statements showed...more
The consumer product safety community is rarely provided guidance by federal court decisions. On Tuesday, however, Judge R. Brooke Jackson of the Federal District Court for the District of Colorado issued an opinion in the...more
FDA Issues Guidance on Concentrated Caffeine - The U.S. Food and Drug Administration (FDA) has released guidance clarifying that "dietary supplements containing pure or highly concentrated caffeine in powder or liquid...more
Product recalls are critical events for firms that produce food and medical products. The lives and health of patients and consumers can be at stake. Companies risk enforcement action by the Food and Drug Administration...more