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:
Why Talc Claimants’ Experts Should Fear New Jersey Courts
Sharon Caffrey, co-chair of Duane Morris’ Trial Practice Group, is quoted in the Law360 article “Why Talc Claimants’ Experts Should Fear New Jersey Courts.”
From the article:
Cleavage fragments, or mineral particles that are found in rocks, can look like asbestos chemically, but they don’t have the same cancer-causing fibrogenic characteristics that asbestos does, Duane Morris LLP partner Sharon Caffrey told Law360.
“It’s not asbestos, and it’s … never been established as a cause of mesothelioma,” Caffrey said.
Visit the Law360 website to read the full article.
After MoCRA, Federal Cosmetics Regulatory Laws Due 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 bipartisan
and 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 intended for sale in
the United States. Here’s what beauty companies need to know.
To read the full text of this article by Duane Morris attorney Kelly Bonner, please visit the firm website,
FDA Draft Guidance Recommends Info to Include in Patient-Matched Guides to Orthopedic Implants
This summer, the U.S. Food and Drug Administration (FDA) issued draft guidance regarding patient-matched guides to orthopedic implants, which are intended to assist in the execution of a pre-surgical plan concurred upon by the patient’s healthcare professional to position an orthopedic implant in a way consistent with the implant’s indicated use. In the draft guidance, FDA recommends information to include in pre-market submissions for patient-matched guides to orthopedic implants. FDA also suggests information for manufacturers to consider when creating the design process for patient-matched guides.
View the full Alert on the Duane Morris LLP website.
FDA Issues New Nitrosamine Impurities Guidance
By Alan Klein, Patrick Gallagher and Michael Fox
On August 4, 2023, the FDA issued a new Guidance to the pharmaceutical industry relating to large molecule drugs left unaddressed in its earlier nitrosamine Guidance publications. (Access the complete Guidance or the abbreviated version.)
Reacting to considerable input from the pharmaceutical industry, both brand and generic, following the agency’s Federal Register request for and receipt of extensive comments on these issues, including scientific data furnished to the agency by NDA and ANDA sponsors over the past year and a half, FDA has now provided drug manufacturers with critical guidelines for conforming their products to what the agency has determined to be safe nitrosamine exposure limits for patients. This comes on the heels of setting similar exposure limits for these products late last month by the European Union’s chief drug regulator, the European Medicines Agency. In its current Guideline, FDA has ranked impacted prescription drugs into 5 categories depending upon their carcinogenic potency, with “1” being the most potent, and “5” the least. Instructing the industry on their responsibility to minimize or eliminate nitrosamine impurities in their products to the extent feasible, the agency has extended the timeline for this task to August 2025, recognizing the complexity of this process and the need to avoid recalls and market disruptions of widely prescribed and important medications.
Business of Fashion Article Quotes Duane Morris Attorney Kelly Bonner
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.
Regulatory Compliance Checklist Post-MoCRA for Beauty and Personal Care Products
MoCRA, Pub. L. No. 117-328, represents the first major statutory change to the authority of the Food and Drug Administration (FDA) to regulate cosmetics since the Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. § 361 et seq., in 1938 and the Fair Packaging and Labeling Act (FPLA), 21 C.F.R. § 701.3, in 1966.
This checklist outlines key regulatory compliance considerations that are specific to personal care products marketed in the United States following the enactment of the federal Modernization of Cosmetics Regulation Act (MoCRA) on December 23, 2022.
To read the full text of this Lexis Nexis Practical Guidance Checklist by Duane Morris attorneys Driscoll Ugarte, Rick Ball, Alyson Lotman, Kelly Bonner and Coleen Hill, please visit the firm website.
Pa. Supreme Court Can Finally Set Proper Venue Standards
In March, the Pennsylvania Supreme Court heard oral argument in Hangey v. Husqvarna on the standards governing venue in a product liability case.
The court’s decision, expected by the end of the year, may provide important guidance on just how much business a corporate defendant must undertake in a plaintiff’s chosen forum for venue to attach.
This article will describe the case on appeal, the venue issues it raises and the precedential context in which it finds itself. We will also suggest a few important takeaways as trial courts and litigants await the disposition of the appeal.
To read the full text of this article by Duane Morris attorneys Alan Klein and Ethan Feldman, please visit the firm website.
Following MOCRA’s Enactment, Unpacking Litigation and Regulatory Risk for Cosmetics Brands
On December 23, 2022, Congress enacted the first major statutory change to the Food and Drug Administration (FDA)’s ability to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act (FDCA). Passed with bipartisan and industry support, the Modernization of Cosmetics Regulation Act (MoCRA) significantly expands FDA’s rulemaking and enforcement authority over cosmetics and creates substantial new compliance obligations for manufacturers, packers, and distributors of cosmetics intended for sale in the United States.
Although MoCRA establishes several new requirements concerning product safety, it provides comparatively little guidance on the kinds of marketing or promotional claims brands can now make about the safety of their products.
To read the full text of this article by Duane Morris attorneys Rick Ball, Alyson Walker Lotman and Kelly Bonner, please visit the Duane Morris website.
L’Oreal Case Highlights Legal Risks Of Anti-Aging Claims
It is a truth universally acknowledged that a woman over 30 must be in want of an eye cream. Or a serum. Or anything, really, so long as it recreates the appearance of youth, vitality or an actual night’s sleep.
The global market for anti-aging cosmetics is expected to reach $93.1 billion by 2027. But as illustrated by a recent decision from the U.S. District Court for the Southern District of New York, Lopez v. L’Oréal USA Inc., promises that a product can turn back time by “restoring skin” or “promot[ing] cell regeneration” can prove costly for brands looking to capitalize on this growing market.
Brands should be mindful of litigation and regulatory risk when making certain anti-aging claims.
To read the full text of this article by Duane Morris associate Kelly Bonner, which was originally published in Law360, please visit the firm website.