MoCRA: Talc Testing and Sample Preparation Requirements
MoCRA: FDA Draft Guidance on Facility Registration and Product Listing
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 On August 7, 2023, FDA announced that it had published a draft guidance on cosmetic product facility registration and product listings, as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The draft guidance intends to help the industry by providing relevant requirements and definitions, explaining who is responsible for making submissions, what details to include,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.
MoCRA: Updates to FDA Safety Substantiation Requirements
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.
Car Break-Ins Expose Shocking Vehicle Vulnerabilities and Spark Multidistrict Litigation: A $200M Settlement Reached by Kia and Hyundai
A Multidistrict Litigation started by a TikTok trend of individuals breaking into cars recently settled for an estimated $200 million. The Plaintiffs alleged that the Defendants—Hyundai and Kia—knowingly sold defective vehicles that were vulnerable to theft while also asserting that Defendants prioritized profits over safety. The vehicles at issue included 2011-2022 Kia vehicles and 2015-2022 Hyundai vehicles that were equipped with traditional “insert-and-turn” steel key ignition systems. Plaintiffs argued that vehicles lacking immobilizer technology were particularly susceptible to theft. According to Plaintiffs, without an immobilizer, anyone with a USB cable could steal the vehicle. Plaintiffs’ lawsuit encompassed various claims, including consumer fraud, unjust enrichment, and deceptive trade practices.
MoCRA: Good Manufacturing Practices – Why Should You Care?
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.
MoCRA: Facility Registration and Product Listing – Where to Begin?
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.
MoCRA: Is My Product a “Cosmetic” and Who Is My “Responsible Person”?
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.
MoCRA: A New Era in the Regulation of Cosmetic Products
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.
New Hampshire Supreme Court Rejects Medical Monitoring Claim in PFAS Case
The Supreme Court of New Hampshire declined to recognize medical monitoring as a remedy or cause of action for plaintiffs who claim exposure to toxic substances. The court based its reasoning on New Hampshire common law and public policy, explaining that an increased risk of injury is insufficient to state a claim for medical monitoring as a remedy or cause of action. See Brown v. Saint-Gobain Performance Plastics Corp., No. 2022-0132, 2023 WL 2577257 (N.H. Mar. 21, 2023).
Husch Blackwell Publishes Its Inaugural Legal Insights for Manufacturing Report
We are pleased to announce that Husch Blackwell has published its inaugural “Legal Insights for Manufacturing” report, which provides a look ahead to 2023 and explores the key trends and issues that will shape the coming year for the manufacturing industry.