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Personal care products include a wide range of items such as cosmetics, skin care products, hair care products, deodorants, and more. Two of the largest segments of these products are shampoo and hair dye. In 2022, there were...more
Two years ago, Congress greatly expanded the authority of the U.S. Food and Drug Administration (FDA) by enacting the Modernization of Cosmetics Regulation Act (MoCRA). This Act requires companies to register each facility...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
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
The U.S. Food and Drug Administration (FDA) announced on April 5, 2024, the results of its 2023 sampling assignment, testing talc-containing cosmetic products for the presence of asbestos. The testing was conducted using...more
In 2023, the U.S. Food and Drug Administration (FDA) took several steps to implement the Modernization of Cosmetics Regulation Act (MoCRA), which was signed into law in December 2022. The law requires cosmetic manufacturers...more
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
The Food and Drug Administration (“FDA”) will begin enforcement of the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) on July 1, 2024. MoCRA represents the biggest regulatory overhaul for the cosmetics industry...more
The U.S. Food and Drug Administration (FDA) had a busy end of 2023 regarding cosmetics facility registration and product listing, which are now required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)....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
Key Takeaways - What Happened: The Food and Drug Administration (FDA) released four updates regarding MoCRA in December....more
A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation...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
On December 14, the US Food and Drug Administration (FDA) issued new instructions for cosmetic companies to use when submitting mandatory serious adverse event reports to the agency. As we reported last year, the...more
As the December 29, 2023 deadline for certain aspects of the Modernization of Cosmetics Regulation Act (“MoCRA”) approaches, FDA has finalized its guidance document governing the registration of cosmetic manufacturing...more
The U.S. Food and Drug Administration (FDA) has announced that it intends to delay enforcement of cosmetic product facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act...more
Key Takeaways - What Happened: FDA announced delayed enforcement for MoCRA facility registration and product listing information....more
The Modernization of Cosmetic Regulations Act of 2022 (MoCRA) is part of the Food and Drug Omnibus Reform Act of 2022 (FDORA) that President Biden signed into law late last year. MoCRA greatly expands the FDA’s oversight...more
Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more
On November 8, 2023, FDA issued a Final Guidance entitled Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (“FDA Guidance”) extending some upcoming deadlines set forth in the...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
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