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Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
The July 1, 2024 deadline is fast approaching for cosmetic product manufacturers to comply with new registration and listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Passage of the...more
“Can’t be good for my health,” a song lyric from Gwen Stefani and No Doubt’s early 2000s single, “Magic’s in the Makeup,” comes to mind when we think of the Food and Drug Administration’s possible motives for recent...more
Contaminated eye drops present serious risks. Not only can they cause blindness and other serious medical conditions, but they have also been linked to at least four cases of premature death caused by severe bacterial...more
PERKINS COIE IS PLEASED TO PUBLISH ITS Q4 FOOD AND CPG LEGAL TRENDS REPORT. This report is a bite-sized version of our annual year in review, providing timely insights on trends so far this year. In Q4 2023, the Consumer...more
Last month the United States Food and Drug Administration (“FDA”) issued its final guidance (“Guidance”) for the industry on cosmetic product facility registrations and product listings, as required by the Modernization of...more
The U.S. Food and Drug Administration (FDA) issued draft guidance on August 7, 2023, clarifying new requirements for cosmetic facility registrations and product listings under the Modernization of Cosmetics Regulation Act of...more
Thanks to the Food and Drug Omnibus Reform Act (FDORA), cosmetic companies will soon be subject to new requirements for registration, product listing, disclosure of ingredients, adverse event reporting, safety substantiation,...more
On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023 (H.R. 2617), which by its name does not appear to have anything to do with cosmetics. However, buried in the approximately 1,650...more
The Food and Drug Administration (FDA) now has additional regulatory authorities over cosmetics, thanks to the Food and Drug Omnibus Reform Act (FDORA). FDORA was a part of the Consolidated Appropriations Act, 2023 (the...more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), signed into law on December 29, 2022, as part of the year-end Consolidated Appropriations Act, 2023, added significant new requirements for manufacturers,...more
On December 29, 2022, U.S. President Biden signed into law the "Consolidated Appropriations Act, 2023," which includes the Modernization of Cosmetics Regulation Act of 2022 (MOCRA). MOCRA reflects the most significant...more
Despite the lack of a private right of action to enforce the U.S. Federal Food, Drug and Cosmetics Act (“FDCA”), the plaintiffs’ bar continually tries to use the FDCA to support other causes of action, and more often than not...more
From severe shortages in medical masks and ventilation equipment worldwide to the curious “toilet paper desert” in America, COVID-19 is creating temporary and long-term disruptions in the availability of both highly...more
If enacted, the law would amend the Federal Food, Drug, and Cosmetic Act (FDCA) to require cosmetic products labeled as “natural” to contain at least 70 percent natural substances, (excluding water and salt) and be made...more
Seyfarth Synopsis: CBD is “thriving” in the current regulatory environment, but is it doing so illegally? As former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb opined last week, “the CBD craze is...more
On March 5, the U.S. Food and Drug Administration (FDA) simultaneously published its independent testing results confirming the presence of asbestos in certain cosmetic products sold by Claire’s and by the girls'...more
LEGISLATION, REGULATIONS & STANDARDS - Personal Care Products Legislation Introduced in Congress - Rep. Janice Schakowsky (D-Ill.) has introduced the Safe Cosmetics and Personal Care Products Act of 2018, which would...more
LEGISLATION, REGULATIONS & STANDARDS - Hawaii Bans Two Sunscreen Ingredients - The Hawaii legislature has passed a law that will prohibit the sale or distribution of sunscreen containing oxybenzone and octinoxate after...more
FDA Issues Guidance on Concentrated Caffeine - The U.S. Food and Drug Administration (FDA) has released guidance clarifying that "dietary supplements containing pure or highly concentrated caffeine in powder or liquid...more
FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more
Sen. Hatch Introduces New Bill Regulating Cosmetic Safety - Sen. Orrin Hatch (R-Utah) has introduced legislation aiming to modernize cosmetics regulation, proposing amendments to the Federal Food, Drug and Cosmetic Act...more
The use of beauty products is “an understudied source of environmental chemical exposures” with a disparate effect on women of color, George Washington University and Occidental College researchers argue. Ami R. Zota, et al.,...more
Food for Thought is a review of significant court decisions affecting the food, beverage, dietary supplements and personal care products industry. Although many cases in this edition focus on class certification, others...more
Last month we summarized the Second Circuit’s important decision in a dispute between plaintiff-appellee Church & Dwight and its principal competitor, defendant-appellant SPD Swiss Precision Diagnostics, concerning SPD’s...more
1. Congress - Senate - FDA Supports Expanded Authority Over Cosmetics - In an Oct. 5 letter to Senator Dianne Feinstein (D-CA), the Food and Drug Administration (FDA) says its current legal authority over...more