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What is the FDA Cosmetic Law (MoCRA)?

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.