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 On August 7, 2023, FDA announced that it had published a draft guidance on cosmetic product facility registration and product listings, as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The draft guidance intends to help the industry by providing relevant requirements and definitions, explaining who is responsible for making submissions, what details to include,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 December 29, 2023.
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.
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
On June 1, 2021, the United States Supreme Court declined to hear Johnson & Johnson’s (J&J) appeal to overturn a $2.12 billion dollar damages award to 22 female plaintiffs who alleged their ovarian cancer was caused by J&J’s talcum powder products. This is a significant setback for defendants in defending consolidated multi-plaintiff mass tort trials and a juries ability to award large punitive damage awards.
Continue Reading United States Supreme Court Declines to Hear Talcum Powder Appeal
A New Jersey appeals court recently overturned talc verdicts totaling $117 million in damages against Johnson & Johnson Consumer Inc. (JJCI) and Imerys Talc America, Inc. (Imerys) after finding expert testimony was Daubert-less, thus improper and warranted new trials.
Continue Reading New Jersey Talc Verdicts Overturned on Appeal for Daubert-Less Expert Opinions