Legislative & Judicial Updates

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As we previously discussed, MoCRA requires cosmetic product manufacturer and processors to register their facilities with the U.S. Food and Drug Administration (FDA). On August 7, 2023, FDA announced that it had published a draft guidance on cosmetic product facility registration and product listings, as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The draft guidance intends to help the industry by providing relevant requirements and definitions, explaining who is responsible for making submissions, what details to include, and how and when to make the submissions. It also provides information on exemptions, such as those for certain small businesses.

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Continue Reading MoCRA: FDA Draft Guidance on Facility Registration and Product Listing

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As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article, in our continuing series of posts diving into each aspect of MoCRA, covers the process for substantiating safety of cosmetic products.

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Continue Reading MoCRA: Updates to FDA Safety Substantiation Requirements

On August 15, 2023, the Missouri Supreme Court in State ex rel. Monsanto Co. v. Mullen, No. SC99942 (Mo. Aug. 15, 2023) (en banc), clarified competing interpretations of Mo. Rev. Stat. 508.010.5(1) (2016) with regard to the proper venue for defendant corporations sued by plaintiffs alleging first injury outside the state of Missouri. In the opinion, the Missouri Supreme Court held that venue is determined based on the location of the defendant corporation’s registered agent at the time the suit is filed, rather than the registered agent’s location on the date of a plaintiff’s first alleged injury, resolving an ambiguity contained in the statute.

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Continue Reading Present Tense Interpretation Clarifies Missouri’s Venue Statute for Corporate Defendants

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On May 20, 2023, the Minnesota legislature amended Minnesota’s Survival of Claims and Wrongful Death statutes. The amendments extend a potential-defendant’s liability by: (1) allowing trustee-plaintiffs to maintain claims on behalf of a deceased party, that historically could not be brought after death; and (2) allowing trustee-plaintiffs to potentially recover for all damages allegedly suffered by the decedent, not just economic harms stemming from and related to the death of the deceased party.…

Continue Reading Minnesota Repudiates Decades of Precedent for Survival and Wrongful Death Actions.

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As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each aspect of MoCRA as we await its full implementation. We will focus on MoCRA’s mandate requiring the Federal Drug Administration (FDA) to establish Good Manufacturing Practices (“GMP”) that the cosmetic industry will have to follow going forward.

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Continue Reading MoCRA: Good Manufacturing Practices – Why Should You Care?

On May 18, 2023, the Illinois General Assembly passed House Bill 219 (Bill) which, if signed by Governor Pritzker, would allow punitive damages in wrongful death cases. Illinois law does not currently permit punitive damages for recovery, only allowing compensatory damages. Suits against state and local government officials will still be exempt from damages if the legislation passes.…

Continue Reading Illinois House Bill Imposing Punitive Damages in Wrongful Death Cases Awaits Governor Pritzker’s Action

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As deadlines approach for cosmetic manufactures to comply with all requirements of MoCRA, there might be some worry on where to start. Husch Blackwell’s chapter by chapter breakdown of MoCRA provides guidance on where to begin. This chapter discusses the requirements of facility registration and product listing with compliance due date of December 29, 2023.

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Continue Reading MoCRA: Facility Registration and Product Listing – Where to Begin?

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As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each aspect of MoCRA as we await its full implementation. To begin, we will discuss whether MoCRA applies to your product and, if so, which entity should serve as the responsible person for ongoing compliance.  

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Continue Reading MoCRA: Is My Product a “Cosmetic” and Who Is My “Responsible Person”?

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The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) was signed into law on December 29, 2022. MoCRA expands the authority of the U.S. Food and Drug Administration (“FDA”) to regulate cosmetics and serves as the most significant change to the regulation of cosmetics since the passage of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938. MoCRA is a seismic shift in the world of cosmetic regulation, bringing new authorities to the FDA that are similar to those that currently exist for food, drugs and medical devices, among other regulated products. MoCRA has sweeping implications for domestic and international cosmetics manufacturers that market products in the U.S.

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Continue Reading MoCRA: A New Era in the Regulation of Cosmetic Products

On March 9, 2023, a federal judge granted summary judgment on causation to three manufacturers of asbestos-containing products in a maritime lawsuit arising from the death of Thomas Deem from mesothelioma. The judge held that Ms. Deem had failed to put on evidence sufficient to show that Decedent’s exposure to the products manufactured by three defendants—John Crane, Inc. (“JCI”), Crosby Valves, LLC, and the William Powell Company—was a substantial contributing factor to his developing mesothelioma. See Sherri L. Deem v. Air & Liquid Systems Corp., et al., No. 17-5965BHS (W.D. Wash. Mar. 9, 2023). …

Continue Reading Frequency, Regularity, Proximity: The Western District of Washington Requires More Than a Product’s Presence to Find Causation