The Food and Drug Administration (FDA) recently issued a Notice announcing the availability of an updated final guidance for the industry entitled “Registration and Listing of Cosmetic Product Facilities and Products.” The...more
On December 11, 2024, the US Food and Drug Administration (FDA) updated its Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. As discussed in our previous On the Subject, FDA...more
As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each...more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest change to the scope of the U.S. Food and Drug Administration's (FDA) regulatory authority over cosmetics since 1938. ...more
As we have reported at length, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposed extensive new requirements related to cosmetic products marketed in the United States. As compliance deadlines for these new...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
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) brought significant changes for the US Food and Drug Administration’s (FDA’s) regulation of cosmetic products. Recent FDA action, including the issuance of final...more
On November 8, 2023, the United States Food and Drug Administration (FDA or agency) announced it does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing under...more
On September 15, 2023, the U.S. Food and Drug Administration (FDA) announced that it is seeking comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067)....more
The U.S. Food and Drug Administration (FDA) has issued draft guidance on cosmetic product facility registrations and product listings, which are required by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)....more
Last Friday, the US Food and Drug Administration (FDA) announced its newly developed draft electronic submission portal — Cosmetics Direct — to facilitate submissions of cosmetic product facility registrations and product...more
As we previously discussed, MoCRA requires cosmetic product manufacturer and processors to register their facilities with the U.S. Food and Drug Administration (FDA). On August 7, 2023, FDA announced that it had published a...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
Earlier this month, in a step toward implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDA issued a draft guidance document titled “Registration and Listing of Cosmetic Product Facilities and...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
Heralding the significant changes coming to the U.S. cosmetics industry starting in 2023, the U.S. Food and Drug Administration ("FDA") has issued draft guidance to companies regarding cosmetic facility registrations and...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
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
Facility Registration: What Is a Facility and Who Has to Register? Section 607 of MoCRA requires the registration of facilities that manufacture or process cosmetics for distribution in the United States. While this...more