On October 25, 2024, FDA issued final guidance to the tattoo industry on the preparation, packing and holding of tattoo inks aimed at preventing the risk of microbial contamination. FDA is getting involved because tattoo ink is considered a cosmetic product regulated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).Continue Reading The Ink is Dry: FDA Issues Final Guidance for Tattoo Industry
On July 29, 2024, FDA announced that it added two new features to Cosmetics Direct, the electronic submission portal used for the facility registration and product listing requirements now in effect under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The portal now allows responsible persons to “discontinue” and “relist” cosmetic products.Continue Reading Cosmetics Direct Gets Two Portal “Fillers” – Discontinuation & Relisting Features Added
A warning letter posted by the Food and Drug Administration (FDA) on June 18, 2024 offers a first glimpse into how FDA may enforce its new regulatory scheme for products that fall within the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)’s purview. While MoCRA was enacted in December 2022 and many of its provisions became enforceable on December 29, 2023, until now, many have wondered how FDA will exercise its new enforcement powers.Continue Reading FDA Unveils Its “First Look” Into How It Will Enforce MoCRA
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
A steady stream of class action lawsuits involving recalled products continued throughout the year.Continue Reading Recall Litigation Report: END OF YEAR RECAP (2023)
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