Consumer Product Safety

On September 11, 2023, the Consumer Product Safety Commission (CPSC) voted to adopt sweeping safety requirements, pursuant to Reese’s Law, for button cell and coin batteries and products containing these batteries or designed to contain them. In a direct final rule, the Commission adopted ASNI/UL 4200A-2023 as the mandatory safety standard for button cell and coin batteries, which includes extensive construction, performance, labeling, and certification requirements.

The Administrative Procedure Act (the “APA”) requires federal agencies to take specific steps when creating new rules and regulations. As a federal agency, the Consumer Product Safety Commission (the “CPSC”) must follow these steps—referred to as “notice and comment rulemaking”—as well as comply with its statutory specific requirements—in order to put into place new product safety regulations.

In early January, after referral by the CPSC to the Department of Justice (and probably the subject of an Acting Chair Adler public comment), fire extinguisher manufacturer Kidde reached a settlement with the government to pay a $12 million civil penalty for underreporting to the CPSC the scope and nature of defect, failure to report timely, making misrepresentations to the CPSC, and misusing a registered safety certification mark. The civil penalty seems to have signaled the start of a more aggressive approach to CPSC enforcement.

There’s a new class action trend consumer product companies need to be aware of that is not only causing additional stress when faced with a recall but also increased expense and adverse publicity.

The food industry has been upended by the recent COVID-19 pandemic – restaurants and bars are scrambling to adjust to a new way of life after governors across America issued statewide “stay at home” orders in response to the coronavirus pandemic. Restaurants are now only permitted to serve take-out or drive-thru orders, and some restaurants have transformed themselves into neighborhood markets, or bodegas, selling food items not labeled for retail.

In the latest challenge to Section 6(b), Congressman Bobby Rush has introduced HR 5565, the Safety Hazard and Recall Efficiency Information Act, which would amend Section 6(b) by stripping it of its most basic due process, as well as increasing enormously the penalties for late reporting.

In a coordinated effort, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9, 2020. The website serves to streamline information regarding agriculture biotechnology products, which are regulated by FDA, USDA, and EPA. The implementation of the website is in response to the June 2019 Executive Order issued by President Donald Trump on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. The Unified Website for Biotechnology Regulation complements prior joint actions such as the Coordinated Framework for the Regulation of Biotechnology, an Obama administration effort to reform the biotechnology regulatory process by enhancing transparency, predictability, and efficacy.

The old joke of “what do Philosophy majors ask at their first job?” takes on a new meaning in the world of Prop 65. On October 7, 2019, the California Chamber of Commerce filed a lawsuit in Federal court for the Eastern District of California (Complaint) challenging Proposition 65 warnings for food that contain the chemical Acrylamide. 

In Fleetwood Mac’s magnum opus, “Landslide,” Stevie Nicks croons, “Well, I’ve been ‘fraid of changin’ ‘cause I’ve built my life around you.” The FTC’s recent workshop on Made in the USA claims reveals a similar hesitancy to evolve, although panel discussions may presage altered approaches to enforcement of these claims. This workshop, held on September 26, consisted mainly of three panel discussions on various aspects of this issue.

I suspect that we’ve all had this experience.  You’ve finished a long day of work, had dinner, and have cozied up on the couch with a glass of wine to watch a re-run of your favorite TV show.  The show goes to commercial and all of a sudden, plastered across your screen, there is an “important consumer alert” concerning the alleged dangers of a particular prescription drug and that “if you or a loved one have been injured” to contact this law firm. 

It was confirmed that Commissioner Bob Adler was elected Vice-Chairman of the CPSC. Because there is no permanent CPSC Chairman at this time, Commissioner Adler will become the Acting Chairman of the agency until a permanent Chairman is confirmed. Commissioner Adler—a Democratic Commissioner—has served on the Commission since 2009.

In a press release this afternoon, Acting Chairman Ann Marie Buerkle announced that she would be withdrawing her nomination to be the permanent Chairman of the CPSC, as well as her nomination for an additional 7 year term, which would have expired in October 2025

On May 14, FDA announced that it issued five Warning Letters to companies that manufacture and market homeopathic drugs for human use. The letters all cite cGMP deficiencies relating to inspectional observations and conclude that the products are misbranded prescription drugs under the Federal Food, Drug, and Cosmetic Act because “in light of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs” and they are not labeled for prescription use only.

In 2019 so far, FDA has issued Warning Letters to eleven separate homeopathic drug manufacturers, including the five letters referenced above. All of the Warning Letters, except one, cite observations from inspections and focus on cGMP and quality violations at the manufacturing facilities, including contamination and varying amounts of active ingredients, that could lead to consumer harm.