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US FDA COSMETIC LABEL REQUIREMENTS
TO IMPORT/EXPORT TO THE UNITED STATES
MoCRA (Modernization Of Cosmetic Regulaitions Act)
Cosmetic products in the United States are regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as various state and local laws. With the implementation of the new Modernization of Cosmetics Regulation Act (MoCRA), cosmetic companies must now meet updated compliance requirements.
One of the most common reasons for Customs Border rejections, warning letters, or product recalls is incorrect labeling. To prevent products from being returned to their origin, destroyed on-site, or recalled after distribution, it is crucial to ensure that both the product and labeling comply with FDA regulations before shipping to the U.S.
Cosmereg offers comprehensive support to both U.S.-based and international companies, assisting them in navigating FDA cosmetic regulations and ensuring compliance for selling cosmetic products in the United States, including compliance with California-specific regulations.
LABELING REQUIREMENTS FOR IMPORTING/EXPORTING COSMETICS TO THE US
1. Ingredients Compliance (US FDA):
All cosmetic ingredients must comply with FDA regulations, be listed using INCI names in descending order of predominance (≥1%), and include any applicable fragrance allergens. Prohibited and restricted substances must be avoided.
2. Label Requirements (US FDA):
Labels must include product identity, net contents, ingredient list (INCI names), manufacturer/distributor details, and any required warnings. Information must be clear, accurate, and in English, following FDA formatting standards.
Product Listing (Cosmetic Direct)
Under the new MoCRA regulations, it is now mandatory to register both the company and its products in the Cosmetic Direct system, which has replaced the previous Voluntary Cosmetic Product Registration Program (VCRP).
Ensure Your Cosmetic Product Ingredients and Labels Are Fully Compliant with U.S. Regulations
We provide a detailed assessment report.
To start, please insert your information in the form and upload the label in PDF format.
The label review typically takes approximately 3 working days per label. For multiple labels, we will provide an estimated timeline upon receiving the required information.
What's included:
☑ We will provide a report that verifies the ingredients against U.S. cosmetic regulations.
☑ We will provide a report to verify that all mandatory information required by the FDA is included on the label.
☑ We will provide unlimited reviews for 30 days.
We respond to inquiries within 24 hours.
