Category: Regulatory

Updated EPA Analysis on Long-Term Health Effects of Formaldehyde Exposure Could Have Lasting Implications for Manufacturers

On April 14, 2022, the Environmental Protection Agency (EPA) released draft conclusions in a report updating its analysis regarding formaldehyde exposure, suggesting that long-term exposures to small amounts of formaldehyde in the environment can increase the risk of rare head and neck tumors, leukemia, and other threats to health. The conclusions are not final agency action. Still, manufacturers should be aware of the potential for EPA’s analysis to influence both regulation and litigation at both the state and federal levels.

For over a decade, there has been much debate and study on the long-term effects of exposure to formaldehyde. The EPA’s new analysis is an update of a 2010 draft EPA report that was heavily panned by scientists, legislators, and chemical manufacturers and that drove the EPA back to the drawing board. For example, the National Academies of Sciences, Engineering, and Medicine criticized the 2010 draft EPA report for failing to describe the rationale behind its methodology and failing to sufficiently support its conclusions.

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Not Just a Rubber Stamp: FDA Revises Its 510(k) Refuse to Accept Policy

Is the decision to submit a 510(k) application versus a Premarket Application (PMA) at the sole discretion of a medical device manufacturer? The answer is not always clear to product liability lawyers, judges, and juries. FDA recently published revised guidance on its “Refuse to Accept Policy for 510(k)s” that reinforces and clarifies that the regulatory path may be analyzed multiple times by FDA before it clears a 510(k) device. This clarification underscores the reality that the type of application submitted is largely dictated by the agency, not the applicant. This post discusses some key takeaways from this new guidance before briefly discussing how this guidance may be implicated in medical device litigation.

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Latest “Right to Repair” Bill Could Signal Changes for Consumers and Manufacturers

On March 14, 2022, a bipartisan trio of U.S. Senators introduced a bill (S.3830) that would require manufacturers to provide the tools and documentation necessary for consumers and third parties to repair electronic equipment. Dubbed the Fair Repair Act of 2022, the bill is the Senate version of a similar bill (H.R.4006) introduced in the House last June. The proposed legislation covers products ranging from agricultural equipment to consumer electronics and is the latest in a series of federal and state proposed laws seeking to codify the “right to repair.” If the bill becomes law, manufacturers will not only have to comply with the Act’s requirements, but they will also need to prepare for potential liability implications.

Attempts at codifying a right to repair are not new in the United States. Calls for automotive right-to-repair legislation go back to the 1970s. But the movement has hit its stride in the last decade. In 2013, Massachusetts became the first state to pass a right-to-repair law requiring vehicle manufacturers to sell their proprietary diagnostic tools and software to third-party repair shops, spurring a flurry of similar bills across the nation and bringing attention to the right-to-repair movement. Though the movement has had little success in codifying a right to repair so far, the tides may be shifting. Indeed, in July 2021, President Joe Biden signed a sweeping executive order that, among other things, encourages the Federal Trade Commission (“FTC”) to enact regulations prohibiting manufacturers from barring the repair of equipment and devices by consumers and independent repair shops.

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FDA Finalizes Voluntary Recall Guidance Imploring Companies to Be “Recall Ready”

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.

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PFAS in Cosmetics Continue to Draw Attention as Litigation and Legislation Efforts Mount

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.

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FTC Continues Crack Down on Unfounded COVID Claims

Last month, the Federal Trade Commission (FTC) announced that it “ordered more than 20 marketers nationwide to immediately stop making baseless claims that their products and supposed therapies can treat or prevent COVID-19.” Like prior rounds of cease-and-desist demands, the letters warned that the alleged violators could be subjected to monetary penalties under the COVID-19 Consumer Protection Act, which Congress passed in 2020. Specifically, the letters warned that businesses engaging in a deceptive act or practice associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19 or a government benefit related to COVID-19 could be subjected to penalties of up to $43,792 per violation.

As the FTC points out, however, “there’s a key point that differentiates these Demands from the more than 400 letters that preceded them.” Namely, copies of the recent round of letters were also sent to the social media platforms used by the advertisers, including Facebook, Instagram, Twitter, YouTube, Etsy, LinkedIn, Shopify, and TikTok. The FTC found that nearly all of the marketers used social media to convey their claims, with many companies utilizing multiple platforms. A recent FTC analysis on the alleged role of social media platforms in the spread of disinformation related to COVID found that deceptive marketers are able to “extend[] the reach of their deceptive COVID claims by using major social media platforms.” The FTC observed that social media’s design helps scammers amplify their deceptive messages while also identifying users most likely to be receptive to those messages. It cautioned, “[b]ogus claims of miracle cures may be successful in attracting consumers’ eyeballs, but they can have devastating consequences for Americans who forgo needed treatment or part with hard-earned money in pursuit of false cures.”

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