The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) grants the U.S. FDA increased authority and supervision over the cosmetic industry. Numerous regulations are set to take effect on December 29th, 2023.
MoCRA, short for Monograph Rule, is a legal framework created by the U.S. Food and Drug Administration (FDA) to regulate the manufacturing, labeling, and promotion of cosmetics in the United States. This rule provides a standardized guide for the cosmetic manufacturing process, ensuring the safety and effectiveness of these products. The overarching goal is to protect consumers from potential health risks associated with the use of cosmetics while promoting innovation and competitiveness in the cosmetics industry. The law became effective for cosmetics in the U.S. market from December 2023.
Which Businesses Must Register with FDA for Cosmetics:
Businesses involved in the manufacturing, packaging, and distribution with information on products distributed in the U.S. are obligated to register with the FDA under the FDA MoCRA law (2023).
Do Small Businesses Need to Register with the FDA for Cosmetics?
Small businesses with three consecutive years of revenue below USD 1 million are exempt from the obligation to register manufacturing facilities and cosmetics under the MoCRA law. However, certain product categories are not exempt from registration, including: • Cosmetics regularly in contact with the mucous membranes of the eyes. • Cosmetics injected into the body. • Cosmetics for internal use. • Cosmetics designed to alter appearance for over 24 hours without user removal.
• FDA Obligations for Cosmetic Businesses Exporting to the U.S:
Registering business facilities.
Designating a U.S. representative office (US agent).
Registering products.
Adjusting cosmetic packaging labels to U.S. standards.
Reporting incidents to the FDA.
Adhering to Good Manufacturing Practices (GMP) for manufacturing facilities.
Conducting safety testing for cosmetics.
Manufacturers, packagers, and distributors providing product information in the U.S. must register with the FDA under the FDA MoCRA law (2023)
U.S. FDA Cosmetic Compliance Services
GOL empowers numerous clients worldwide every year in navigating FDA compliance challenges. We're well-versed in guiding you to fulfill MoCRA requirements, ensuring you not only meet the December 29, 2023, deadline but also thrive beyond it..
Facility Registration
We can help you achieve MoCRA compliance by registering your cosmetic facilities with FDA. We can also act as your U.S. Agent if your facilities are located outside the USA.
Product Listings
FDA cosmetic listings can be complicated to file. We help you save time, money, and the frustration of doing it yourself by making product listings quick and easy.
Adverse Event Reporting
Complete Adverse Event Report within 15 days from the first date you received the complaint from the consumer. GOL Adverse Event Report Assistance helps you to stay on top of completing the initial report and response to FDA follow ups.
Label & Ingredient Review
MoCRA imposes new changes on how cosmetic product labels are handled. Our experienced team of labeling specialists make it easy for your company to remain compliant with all labeling regulations.
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