In April, the U.S. Food and Drug Administration (FDA) released the results of its 2023 sampling assignment, testing for asbestos in talc-containing products. The results confirmed the absence of asbestos in all 50 samples tested, marking the third consecutive year of asbestos-free talc products in the United States. While this news is reassuring for industry participants, the legal landscape remains complex due to ongoing litigation. This article explores the legal implications, potential risks, and regulatory changes related to asbestos detection in cosmetic talc products.
MoCRA: What’s on the horizon for PFAS?
By Magda Patitsas, Dominique Savinelli & Jen Dlugosz on
This article is one of a series of posts diving into each aspect of The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) as the industry awaits MoCRA’s full implementation. This installment focuses on MoCRA’s approach to the regulation of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products.
MoCRA: Talc Testing and Sample Preparation Requirements
By Magda Patitsas, Jen Dlugosz & Seth Mailhot on
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 a continuing series of posts diving into each aspect of MoCRA, covers the talc testing and sample preparation requirements which will be established by the FDA under MoCRA.
MoCRA: FDA Draft Guidance on Facility Registration and Product Listing
By Magda Patitsas, Seth Mailhot & Paula Pastuskovas on
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 On August 7, 2023, FDA announced that it had published a draft guidance on cosmetic product facility registration and product listings, as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The draft guidance intends to help the industry by providing relevant requirements and definitions, explaining who is responsible for making submissions, what details to include,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.
MoCRA: Good Manufacturing Practices – Why Should You Care?
By Magda Patitsas, Jen Dlugosz & Seth Mailhot on
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?
By Magda Patitsas, Jen Dlugosz & Seth Mailhot on
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”?
By Magda Patitsas, Jen Dlugosz & Seth Mailhot on
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
By Magda Patitsas, Jen Dlugosz & Seth Mailhot on
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.
Heavy Metals in Baby Food – Congressional Report Unleashes a Flood of Litigation
By Tim Larkin & Leah Kaiser on
Posted in Product Safety
Heavy metals, such as arsenic, lead, cadmium, and mercury, are present in baby foods produced by U.S. baby food manufacturers according to a report released in February by the U.S. House of Representatives Subcommittee on Economic and Consumer Policy. Heavy metals are considered dangerous to human health and are especially concerning for children and babies, who are more susceptible to the neurological effects associated with exposure to heavy metals.