FDA recently issued final guidance regarding the initiation of voluntary product recalls and its related suggestions on how to be “recall ready.” The guidance – covering voluntary recalls of food, drugs, devices, biological products, cosmetics, and tobacco – emphasizes the importance of a company’s recall readiness at all stages of a product’s distribution chain and provides companies with suggested measures to prepare for and implement voluntary recalls. It also advises companies on best practices for working with FDA to initiate a timely voluntary recall.
In June 2021, we published Cosmetics Companies: Beware of PFAS, highlighting the recently introduced No PFAS In Cosmetics Act and recommending that cosmetics and personal-care product companies examine their products and supply chains to determine if, when, and where PFAS may affect their businesses. As anticipated, PFAS in cosmetics has continued to draw attention, with the filing of at least two lawsuits and the anticipated enactment of PFAS legislation in several states.
The No PFAS In Cosmetics Act, which seeks to ban the use of intentionally added per- or polyfluoroalkyl substances (“PFAS”) in cosmetics, was introduced in the House on June 17, 2021. The bill has been assigned to the House Energy and Commerce Subcommittee on Health, but no hearing has been scheduled. Ultimately, the bill will require the Department of Health and Human Services to issue and finalize a rule banning the use of intentionally added PFAS in cosmetics. In the meantime, on February 2, 2022, over 30 senators sent a letter to President Biden requesting funding for Fiscal Year 2023 for PFAS research, regulatory efforts, and testing.
A new study regarding phthalates has garnered media attention this month, but readers should recognize the study’s limitations. Some media coverage of this study blurs the important distinction between “association” and “causation.”
What Are Phthalates?
Phthalates, sometimes called plasticizers, are a group of chemicals generally used to make plastics more durable, or to dissolve other materials. Phthalates may be found in products such as vinyl flooring, food wraps, intravenous tubing, lubricating oils, and some personal care products such as shampoos, soaps, and hairsprays.
It’s no secret that the regulatory landscape of cosmetics and personal care products as we know it is changing. Over the last few years, Congress, along with industry and consumer groups, have made a combined effort to push for heightened regulation of these products. The latest effort, introduced in Congress on June 15, 2021, seeks to ban the addition of per- and polyfluoroalkyl substances (generally known as “PFAS”) in cosmetics and personal care products.
The Ninth Circuit has confirmed that a lack of summary judgment evidence linking a product to concrete injury may properly halt a would-be class action in its tracks if a defendant preemptively moves for summary judgment before plaintiffs have the chance to move for class certification.
As we explored in an earlier post, the plaintiffs in Browning et al. v. Unilever United States Inc. represented a would-be class alleging that defendant Unilever failed to disclose that its St. Ives facial scrubs caused “micro-tears” of the skin. In early 2019, the United States District Court for the Central District of California granted summary judgment in favor of Unilever. The court held that the plaintiffs failed to establish the alleged micro-tears constituted a safety hazard, and found that causation was lacking because the plaintiffs presented no evidence that St. Ives — and not some “other products or lifestyle” choices — caused the complained-of skin conditions.
Consumer demand for natural cosmetics continues to grow. A Bloomberg News article projected the natural cosmetics market to grow over 5% annually and to be worth $48.04 billion by 2025. The article noted that high demand for natural products among millennials is “driving the growth,” which means the trend is likely to continue. Despite the increasing market share, the federal agencies that regulate the sale and advertising of cosmetics, the Food & Drug Administration (FDA) and the Federal Trade Commission (FTC), still have not formally defined the term “natural” as applied to cosmetics.