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9月 26, 2024

FDA MoCRA規則が化粧品ブランド事業方法を変える

New FDA rules change the way cosmetic brands do business. Article title.

The FDA has introduced new MoCRA rules that will affect various aspects of cosmetics, including those found in your medicine cabinet, shower routine, and skincare products. These rules represent a significant shift for cosmetic companies, who will now have to comply with more stringent requirements. According to David Lennarz, co-founder and president of Registrar Corp., these changes are long overdue, as the cosmetics industry has only faced voluntary guidelines since the Food, Drug, and Cosmetic Act of 1938.

The new regulations, part of the Modernization of Cosmetics Regulation Act (MoCRA), impose five key requirements for companies to follow. First, cosmetic companies must register their facilities with the FDA and list all marketed cosmetic products, including their ingredients. Second, they are required to keep these details up-to-date.

Third, as of now, companies must provide a way for consumers to easily report adverse reactions directly from product packaging. This can be achieved through simple means, such as a QR code or a URL, allowing consumers to report any negative experiences with the product.

Additionally, companies must maintain detailed records to ensure the safety of their products. This involves alerting the FDA about any adverse effects that occur, a process aimed at consumer protection. Last year alone, the FDA tracked 5,000 adverse effects from cosmetic products, highlighting the need for these new regulations.

Lennarz emphasizes that once companies receive reports of adverse effects, they must determine whether a product recall is necessary to safeguard consumers. The FDA is now actively enforcing these rules, marking a pivotal moment for the cosmetics industry as it transitions to a more transparent and regulated environment. These changes aim to enhance consumer safety and product accountability in the cosmetics market.

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