On December 11, 2023, the United States Government Accountability Office (GAO) issued a report calling for FDA to strengthen its efforts to implement the Modernization of Cosmetics Regulation Act (MoCRA), and institute reforms necessary to exercise its new authorities under MoCRA.
The GAO’s report, entitled“COSMETIC SAFETY: BetterPlanning Would
Enhance FDA Efforts to Implement New Law,”
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FDA Updates Instructions for Serious Adverse Event Reporting for Cosmetic Products under MoCRA
On December 14, 2023, FDA published updated instructions for reporting serious adverse events for cosmetic products, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), enforceable starting December 29, 2023.
FDA recommends that industry “responsible persons” as defined by MoCRA report serious adverse event reports for cosmetic products by using the current
Retailers’ Clean Beauty Claims Fuel Consumer Doubts and Lawsuits
In the beauty world, a “clean” product brings to mind one or more of the following features: sustainable, nontoxic, ethically made, cruelty-free, or even vegan.
Such broad associations speak to the appeal of “clean beauty” products: They can make consumers—especially climate-conscious Gen Z and millennials—feel like they’re making the better choice for themselves and the
FDA Publishes Updated SPL Implementation Guide with Validation Procedures
Yesterday FDA published an updated Structured Product Labeling (SPL) Implementation Guide with Validation Procedures, including updates to cosmetics product facility registrations and product listings that are now included within the SPL framework.
Yesterday’s release updates the SPL Implementation Guide published by FDA on October 13, 2023, which included facility registrations and product listings
BREAKING NEWS – FDA Pushes Back Enforcement Deadline for MoCRA Facility Registration and Product Listing Requirements to July 1, 2024
Today, FDA announced updated guidance regarding its MoCRA rollout.
FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.
FDA Issues Update On Ongoing Cosmetic Product Facility Registration and Product Listing Under MoCRA
Today, FDA announced that it is effectively pushing back its anticipated October launch date for electronically submitting cosmetic product facility registration and product listing information required by the Modernization of Cosmetics Regulation Act (MoCRA).
MoCRA requires any facility that manufactures or processes cosmetic products intended for sale in the United States—irrespective of whether the facility is located
What’s Driving Beauty Brands to Shutter in 2023?
Duane Morris partners Robert Kum and Cyndie Chang are quoted in the Glossy article “The unseen legal turmoil driving beauty brands to shutter in 2023.”
Despite positive projections about the future of the beauty industry, insiders say brands of all sizes are quietly grappling with unseen legal struggles.
[Founders] blamed, in large part,
New York Federal Court Dismisses Putative Class Action Suit Alleging Deceptive Marketing Of PFAS-Containing Mascaras
On September 30, 2023, the US District Court for the Southern District of New York dismissed a putative class action in which plaintiffs claimed they would not have purchased or paid a premium price for certain waterproof mascaras had they known of the presence of per- and polyfluoroalkyl substances (“PFAS”).
In a 22-page opinion, the
The Class Action Weekly Wire Podcast talks MoCRA featuring Kelly Bonner
In Episode 35 of the Class Action Weekly Wire podcast, host Jerry Maatman interviews Duane Morris associate Kelly Bonner about the Modernization of Cosmetics Regulation Act (MoCRA). Watch the episode below:
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MoCRA Requires Federal Regulatory Overhaul
On December 23, 2022, Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA)—the first major statutory change to the U.S. federal government’s ability to regulate cosmetics since 1938. Passed with bipartisanand industry support, MoCRA expands the Food and Drug Administration’s authority over cosmetics, and creates substantial new obligations for manufacturers, packers and distributors of cosmetics