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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 On August 7, 2023, FDA announced that it had published a draft guidance on cosmetic product facility registration and product listings, as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The draft guidance intends to help the industry by providing relevant requirements and definitions, explaining who is responsible for making submissions, what details to include,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Continue Reading MoCRA: FDA Draft Guidance on Facility Registration and Product Listing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

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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?

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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

The President swore in a new face to the Commission for the Consumer Product Safety Commission (CPSC) on June 30, 2022. Mary T. Boyle, however, is not an entirely new face as she served in various positions within the CPSC for more than a decade. She formerly served in various leadership rules, including CPSC’s Executive Director from 2018 before being confirmed as the new Commissioner. Ms. Boyle also served as CPSC’s Senior Counselor for Policy and Planning, General Counsel, and Deputy General Counsel.…

Continue Reading Mary T. Boyle: New Commissioner for the Consumer Product Safety Commission

About a year ago, the Office of Environmental Health Hazard Assessment (OEHHA) proposed to amend the short form warning rules for Proposition 65.  Proposition 65 requires businesses to warn Californians about exposure to certain chemicals through “clear and reasonable” warnings.  There are currently two forms of “safe harbor” warnings, one of which is the short form warning. The short form warning requires less detail, takes up less label space, and does not require the listing of any chemical names, which has made it a popular choice.
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Continue Reading OEHHA Proposes (Additional) Changes to Prop 65 Short Form Warnings

On October 1, 2021, California Governor Gavin Newsom signed California Senate Bill No. 447 into law, which permits a deceased individual’s personal representatives or successors-in-interest to recover damages for the decedent’s pain, suffering, or disfigurement in a lawsuit. Prior to this law, those suing on behalf of a deceased individual were limited solely to damages for the decedent’s injuries and punitive damages, if warranted. They could not previously recover for the decedent’s pain and suffering.
Continue Reading California Permits Pain and Suffering Damages for Survival Actions