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Talc is a mineral ingredient used in many cosmetic and personal care products, including baby powder, root touch-up products, and blush. Because both talc and asbestos are naturally occurring minerals that may be found in close proximity in underground deposits, there is risk for contamination of asbestos in talc-based products.Continue Reading Talc About Toxic-Free Cosmetics

As we have previously discussed, in recent years, consumers have increasingly demanded “cleaner” beauty products and more transparency in product labeling. In addition to the FDA’s increased authority to regulate cosmetics under MoCRA, a number of states have now taken steps to regulate ingredients in cosmetics by limiting, and in some instances even banning, the use of certain ingredients that may be potentially harmful or toxic.Continue Reading Is it Allowed? Companies Face New Challenges with an Ever-Evolving List of “Off Limits” Ingredients in Cosmetic Products

For years, cosmetics and other personal care companies have faced calls for “cleaner” products and more transparent labeling. And every day, new ingredients get added to the “naughty” list. Recently, per- and polyfluoroalkul substances  (PFAS)—a group of manmade chemicals used primarily for their conditioning properties—have come under fire. Even as research indicating the dangers of PFAS is limited, the widespread use of PFAS has led to state restrictions on use in personal care products, and proposed legislation that would ban PFAS in cosmetics on a federal level.Continue Reading PFAS Litigation: Another Headache for the Beauty Industry

In vitro fertilization (IVF) is one of the most common types of fertility treatment, but the process is also extremely sensitive, invasive, and expensive. All of these factors come into play in a series of recent lawsuits following CooperSurgical’s December 5, 2023 recall of three lots of its embryo culture media—a substance that allows for the development of fertilized embryos. According to the company’s announcement, CooperSurgical had received a high number of customer complaints indicating that its embryo culture media caused impaired embryo development.Continue Reading Recall Litigation Report: CooperSurgical Faces Multiple Lawsuits Following Recall of IVF Embryo Culture Media

What a company knew and when is a critical question in any lawsuit involving recalled products. And the answer may be complicated, particularly when a manufacturer announces multiple recalls and expands previous recalls.Continue Reading Recall Litigation Report: Mid-America Pet Food Faces Putative Class Action Over Recalled Pet Food Products

On December 18, 2023, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, the electronic submission portal for facility registration and product listing required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and published a User Guide for the portal.[1] Cosmetics Direct contains user friendly data entry forms, performs initial validations, creates and saves the structured product labeling (SPL) submission, and submits the SPL to FDA.Continue Reading FDA Launches Cosmetics Direct and Issues Final Guidance on Facility Registration & Product Listings Required under MoCRA

On December 14, 2023, the FDA issued an update with further instructions on  serious adverse event reporting under the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), which is enforceable starting December 29, 2023.Continue Reading FDA Provides Updated Instructions for Reporting Serious Adverse Events under MoCRA

Just over a month after the Food and Drug Administration (FDA) announced its intent to delay enforcement of facility registration and product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the Government Accountability Office (GAO) issued a report, “COSMETIC SAFETY: Better Planning Would Enhance FDA Efforts to Implement New Law,” with seven recommendations to strengthen FDA efforts to implement its new cosmetic oversight responsibilities.Continue Reading GAO Report Concludes that the FDA Needs to Strengthen its Efforts to Implement MoCRA

On October 13, 2023 The FDA announced that two of the requirements set forth in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)— facility registration and product listing—will be included as part of the Structured Product Labeling (SPL) framework. SPL is a document formatting standard adopted by FDA for exchanging product-related information. Continue Reading FDA Publishes SPL Guide for MoCRA Facility Registration and Product Listings