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 On August 7, 2023, FDA announced that it had published a draft guidance on cosmetic product facility registration and product listings, as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The draft guidance intends to help the industry by providing relevant requirements and definitions, explaining who is responsible for making submissions, what details to include,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.
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.
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.
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 July 1, 2024.
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.
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.
Mallory v. Norfolk S. R.R. Co., Civ. A. No. 3 EAP 2021, Slip. Op. J-49-2021 (Pa. Dec. 22, 2021) may be one of the most cited decisions in Pennsylvania state courts these days, as defendants file an array of motions seeking dismissal of their clients for lack of personal jurisdiction in cases where the only nexus between the defendant and Pennsylvania is the defendant’s registration to do business in the Commonwealth. We previously blogged on this issue here and here, and we were hopeful that the bold statement made in Mallory would clarify the previously murky law on point, but the battle regarding consent jurisdiction rages on.
New York’s Court of Appeals recently reversed a $16,500,000 asbestos jury verdict in a case brought by decedent Florence Nemeth and her husband, who alleged that Mrs. Nemeth’s cancer was caused by her use of Desert Flower Talcum Powder. In Nemeth v. Brenntag North America, et al., 2022 WL 1217464 (Ct. App. NY Apr. 26, 2022), the state’s highest court overturned the decision on the grounds that the plaintiff’s experts failed to present sufficient evidence to prove that the talc-based cosmetic powder caused decedent’s peritoneal mesothelioma.
On September 27, 2021, after 18 days of trial and a mere hour of deliberations, a City of St. Louis, Missouri jury rendered a defense verdict in favor of Johnson & Johnson (“J&J”) on claims of three women diagnosed with ovarian cancer. Forrest v. Johnson & Johnson, et al., No. 1522-CC00419-02 (Mo. Cir. Ct., St. Louis Cty.). Notably, in 2018, a City of St. Louis jury returned a staggering $4.7 billion verdict in favor of 22 woman who claimed that J&J’s asbestos-contaminated talcum powder caused their ovarian cancer.
Continue Reading Jury Returns Defense Verdict in Third Post-Pandemic Ovarian Cancer Talc Trial