MoCRA: Talc Testing and Sample Preparation 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 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: 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?
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.
Illinois House Bill Imposing Punitive Damages in Wrongful Death Cases Awaits Governor Pritzker’s Action
On May 18, 2023, the Illinois General Assembly passed House Bill 219 (Bill) which, if signed by Governor Pritzker, would allow punitive damages in wrongful death cases. Illinois law does not currently permit punitive damages for recovery, only allowing compensatory damages. Suits against state and local government officials will still be exempt from damages if the legislation passes.
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.
Cook County Issues Revised HIPAA Order, Narrowing the Utility of Medical Provider Subpoenas
On November 5, 2021, Cook County’s HIPAA Qualified Protective Order (“QPO”) was considerably reconstructed in light of the Illinois Supreme Court’s decision in Haage v. Zavala, 2021 IL 125918. Illinois litigators were alerted of these new changes through a Law Division-issued order, titled General Administrative Order 21-3 (“GAO”), and a corresponding standard QPO. According to the GAO, to the extent that any previously entered QPO conflicts with the new one, the new QPO controls, and motions to vacate, amend, and/or modify are not required. As explained below, these changes, which affect virtually all Cook County cases involving bodily injuries, will make fact investigation and damages substantiation significantly more difficult for defendants.
Latent Injury Exception to Illinois Workers’ Compensation Legislation Challenged
On May 17, 2019, Illinois adopted legislation eliminating the state’s 25-year statute of repose under the Illinois Workers’ Compensation Act for latent diseases. The legislation overturned the prominent Supreme Court decision in Folta v. Ferro Engineering which established clear precedent that an employee’s exclusive remedy lies under either the Illinois Workers’ Compensation or Occupational Diseases Act. Recently, in Patton v. A.W. Chesterton, defendant McNulty Brothers Company (McNulty) attempted to challenge the constitutionality of the 2019 legislation when it moved to dismiss Mr. Patton’s lawsuit arguing his case was barred by the Illinois Workers’ Compensation Act. Mr. Patton allegedly worked as a carpenter at McNulty from 1969 through 1973. Mr. Patton alleged that he regularly worked with asbestos-containing ceiling tiles and around asbestos-containing joint compound while he was employed by McNulty. Mr. Patton was diagnosed with mesothelioma in September of 2019, four months after the amendment of the Illinois Workers’ Compensation Act. Mr. Patton subsequently filed his complaint in the Third Judicial Circuit of Madison County, Illinois on October 15, 2019.