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
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
For many years, personal care companies have used a wide variety of ingredients that are now under scrutiny. Recently, Per- and Polyfluoroalkyl substances (PFAS) have received increased attention. Once intentionally added to products, several state laws ban or modify the total amount of these ingredients permitted in various products. Now, a new bill introduced in U.S. Congress late last year aims to follow suit.Continue Reading What’s In and What’s Out? Cosmetic Companies Face Ingredient Compliance Conundrum
Crowell & Moring’s Holly Melton, Roy Abernathy, and Helen Ogunyanwo discuss what brands need to know about consumer reviews, testimonials, and endorsements in 2024. Read more in Law360: Link to Full Article
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
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