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
The U.S. Consumer Product Safety Commission (CPSC) regulates consumer products sold in the United States, and jewelry and accessories are no exception. Whether your business offers costume jewelry, fine jewelry, watches...more
Across the country, devastating injuries have been caused by small, alcohol-fueled tabletop fire pits that unexpectedly erupt in flames. Marketed as decorative and “smokeless,” these products have been linked to severe burn...more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is considered the most significant expansion of the U.S. Food and Drug Administration’s (FDA) authority to regulate cosmetics since the enactment of the Food, Drug...more
Last month, the US Food and Drug Administration (FDA) issued a draft guidance explaining how it intends to implement the mandatory recall authority established under the Modernization of Cosmetics Regulation Act of 2022...more
On December 22, 2025, the U.S. Department of Justice (DOJ), in coordination with the U.S. Consumer Product Safety Commission (CPSC), announced that it filed a lawsuit in the U.S. District Court for the District of Maryland...more
On December 22, 2025, the US Department of Justice (DOJ) sued Stanley Black & Decker in the US District Court for the District of Maryland, alleging violations of the Consumer Product Safety Act (CPSA)....more
The U.S. Food and Drug Administration (FDA, or the Agency) published a draft guidance explaining its mandatory recall authority for cosmetic products on December 18, 2025 (90 FR 59129). Entitled “Questions and Answers...more
If you are taking (or have recently taken) a prescription drug that is now subject to a recall, there are several important facts you need to know. One of these facts is why your prescription was recalled. ...more
What does FDA's new guidance do? The enactment of the Modernization of Cosmetics Regulation Act (MoCRA) in 2022 provided FDA with the clear authority to mandate cosmetic recalls. Accordingly, FDA may order a recall when it...more
On Dec. 10, 2025, the FDA announced that, as a result of the ongoing investigations into the contamination of ByHeart infant formula, the Centers for Disease Control expanded the case definition to include any infant...more
Product-related injuries are alarmingly common. Often, these injuries result from defects that affect large numbers of products—in some cases, hundreds of thousands or millions of products sold across the country. ...more
DermaRite Industries, LLC (DermaRite) has announced a voluntary recall of several of the company’s products, including creams, soaps, hand sanitizers, skin protectants, and deodorant. According to DermaRite, the recalled...more
Each year, the U.S. Consumer Product Safety Commission (the “CPSC” or “Commission”) utilizes its import surveillance program, surveys the market, and reviews reports from consumers and companies, to identify violations of the...more
As technology and regulations continue to reshape the automotive industry, product litigation is expanding. Plaintiffs are increasingly using proactive actions, such as recalls and service campaigns, as a springboard for...more
As food and beverage brands begin to scale, they will often look to partner with a contract manufacturer (co-man), to increase production or expand into new product categories. Given that co-mans are not only producing and...more
Federal and state health authorities are investigating a recent infant botulism outbreak linked to certain infant formula products. In response, FDA expanded its initial advisory into a nationwide recall of multiple lots...more
New rules under the General Product Safety Regulation (EU) 2023/988 (GPSR) have applied since 13 December 2024 across the European Economic Area (EEA) – comprising the European Union member states, plus Iceland, Liechtenstein...more
The pharmaceutical retailer AvKARE has published a voluntary recall notice for five different types of eye drops previously available through the company’s online store. The recall involves products sold by BRS Analytical...more
On June 2, 2025, the U.S. Food and Drug Administration (FDA) announced the deployment of its own artificial intelligence system, “Elsa.” The large language model-powered system was scheduled for full-scale implementation...more
FDA Inspections Have Not Stopped Since the Government Shutdown - Since the shutdown commenced, there have been more than 70 Class I device recalls and 20 reported inspections. For-cause and scheduled inspections of device,...more
By order of July 16, 2025, the Court of Appeal of Turin (Specialized Section for Business Matters) ruled on the appeal filed by Stellantis, Groupe PSA Italia, and Automobiles Citroën in the "Takata airbag" case concerning the...more
If you are taking a drug that has been recalled, it is important to make sure you know what the recall means for you. Some drug recalls are far more serious than others, and it is important not to stop taking a drug if taking...more
An industry group's recommendation about a Feastables "blind taste test," a lawsuit alleging added sugar is not a "breakfast essential," a challenge to West Virginia's law banning synthetic color additives, and more....more
A recent summary judgment decision out of the Southern District of Georgia illustrates the critical role of defect evidence (or lack thereof) in negligence claims involving medical devices. As the plaintiff in Rudzinskas v....more
Running a consumer products retail business is hard work. In addition to the day-to-day challenges facing any business, the applicable regulatory environment can be a shifting, confusing morass that befuddles even the most...more