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
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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…
Introducing Cosmetics Direct – FDA’s New Electronic Portal for Facility Registration and Product Listing of Cosmetic Product Facilities and Products Under MoCRA
Continuing its implementation of the Modernization of Cosmetics Regulation Act’s (MoCRA), and following on the heels of FDA’s Draft Guidance on Facility Registration and Product Listing (previously discussed here), on September 15, 2023, FDA announced its newly developed draft electronic submission portal, Cosmetics Direct, to assist persons submitting cosmetic product facility registrations and product…
FDA Issues Long-Awaited Draft Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products Under MoCRA
MoCRA’s long-awaited rollout continues as today FDA released draft guidance to assist persons submitting cosmetic product facility registrations and product listings under newly-added Section 607 of the federal Food, Drug, and Cosmetic Act (FD&C Act).
Background
Section 607(a) of the FD&C Act requires every person that owns or operates a facility that “engages in the…
Duane Morris Attorney Kelly Bonner Quoted in Business of Fashion Article
Duane Morris attorney Kelly A. Bonner was quoted in an article in The Business of Fashion titled “What Beauty Needs to Know About the Biggest New Regulations in 80 Years,” about the Modernization of Cosmetics Regulations Act (MoCRA) recently signed into law. To read the full text of this article, please visit the firm website