On April 5, 2024, the U.S. Food and Drug Administration (FDA) confirmed that its third-party testing of cosmetic talc products for 2023 identified no traces of asbestos in any of the 50 cosmetic samples tested. FDA’s 2023 results, which were reported in a Cosmetics Constituent Update, are consistent with its testing for 2022 and 2021, which also failed to detect ..read more

By Alan Klein and Ethan Feldman In Hangey v. Husqvarna, the Pennsylvania Supreme Court recently ruled that the percentage of a corporate defendant’s total revenue generated from a forum county alone is insufficient to support the proposition that a defendant does not “regularly conduct business” in the county when analyzing whether a lawsuit’s venue is ..read more

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, the California Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Prop 65. “[Prop 65] requires products sold in California to have a special ..read more

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 ..read more

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 ..read more

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 ..read more

On September 6, 2023, the FDA released three draft guidance documents that seek to “modernize” the 510(k) premarket notification process.  Ever since the FDA first proposed “transformative new steps” to the program in 2018, the agency has promised to further update the 510(k) clearance pathway in an effort to better balance technological innovation and patient ..read more

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 ..read more

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 ..read more

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 ..read more