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
The FDA will begin to enforce the Modernization of Cosmetics Regulation Act (MoCRA)’s facility and product registration requirements on July 1, 2024. MoCRA has a significant impact on U.S. cosmetic manufacturers and marketers (and suppliers of ingredients). Companies should initiate steps to implement compliant systems now. Is your company prepared? To help make sure you
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
Click here to listen to Rachel Raphael share her insights on the Modernization of Cosmetics Regulation Act (MoCRA) with Allison Stevenson, co-chair of the National Association of Women Lawyer’s (NAWL) Advocacy committee, on Episode 67 of the NAWL Podcast.
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
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