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
HIGHLIGHTS IN 2023 DEVELOPMENTS - FDA Takes Steps to Implement MoCRA - In 2023, the U.S. Food and Drug Administration (FDA) took several steps to implement the Modernization of Cosmetics Regulation Act (MoCRA), which...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
ACI’s 11th Annual Legal, Regulatory & Compliance Forum on Cosmetics & Personal Care Products is back on March 20–21, 2024, in New York City. The “Modernization of Cosmetic Regulation Act of 2022” (MoCRA) on the federal...more
Last week, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, a new electronic submission portal for the registration and listing of cosmetic product facilities and products under the Modernization of...more
Cosmetics Regulation - Currently, cosmetics are regulated through the Federal Food, Drug, and Cosmetic Act (FDCA)– which has recently been revamped by the Modernization of Cosmetics Regulation Act (MoCRA)–and various...more
This article is one of a series of posts diving into each aspect of The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) as the industry awaits MoCRA’s full implementation. This installment focuses on MoCRA’s...more
Registration and listing requirements are old news for many FDA-regulated products, but FDA did not have authority to require cosmetic product listings or facility registrations until just recently. FDA had a voluntary...more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is significantly changing regulation of the cosmetics industry in the U.S. For the first time, cosmetics manufacturers and brand owners will need to register...more
The U.S. Food and Drug Administration has issued a draft guidance to assist companies submitting cosmetic product facility registrations and cosmetic product listings to the FDA in compliance with 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
The American Conference Institute is hosting its first West Coast Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in Santa Monica on September 28-29, 2023! This conference comes just in time to...more
On August 7, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance on new requirements for registration and listing of cosmetic product facilities and products. The draft guidance follows the signing of the...more
On August 7, 2023, the Food and Drug Administration (FDA) published draft guidance regarding the registration and listing of cosmetic products, a new requirement under the Modernization of Cosmetics Regulation Act of 2022...more
The Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) contains several provisions that will go into effect on December 29, 2023. We have previously explained some of the main provisions of MoCRA in Amendments to...more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is bringing sweeping changes to the cosmetics industry. One such change requires a “responsible person” to maintain and submit certain adverse event reports to...more
Since the late December 2022 seismic shift in the legal landscape for cosmetic companies – when Congress passed and President Biden signed the Modernization of Cosmetics Regulation Act, or MOCRA, into law (see our prior post...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 cosmetics industry is undergoing massive change, with the newly passed “Modernization of Cosmetics Regulation Act 2022”. At American Conference Institute’s 10th Annual Forum on Cosmetics & Personal Care Products join our...more
President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), as part of the Consolidated Appropriations Act, 2023. This is the first major reform of cosmetics regulation since the Federal...more
The highly anticipated cosmetic regulatory overhaul, Modernization of Cosmetics Regulation Act (MoCRA), was signed into law on December 29, 2022, ushering heightened regulatory oversight of cosmetic products and facilities....more
As part of the Consolidated Appropriations Act, 2023, President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”). This is the first major reform of cosmetics regulation since the Federal...more