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MoCRA Cosmetic Product Listing
FDA Cosmetic Product Listing under the Modernization of Cosmetics Regulation Act
Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the US Food and Drug Administration (FDA) requires responsible persons to submit product listings for cosmetic products marketed in the United States, unless an exemption applies.
Cosmetic product listing is an important part of US regulatory compliance and is separate from cosmetic facility registration.
Modernization of Cosmetics Regulation Act
What is MoCRA cosmetic product listing?
Modernization of Cosmetics Regulation Act
What is MoCRA cosmetic product listing?
MoCRA requires the responsible person, generally the manufacturer, packer or distributor whose name appears on the product label, to submit information about each applicable cosmetic product to the FDA.
Key requirements include:
- Cosmetic product listings must be submitted to the FDA in accordance with applicable deadlines
- Product listings must be updated annually, and relevant changes must be reported
- Certain small businesses and product categories may qualify for exemptions
- Product listing does not constitute FDA approval or confirmation of regulatory compliance
Product listing
Information required for MoCRA product listing
Product listing
Information required for MoCRA product listing
The following information is generally required:
- Cosmetic product name and product category
- Name and contact details of the responsible person
- Applicable cosmetic manufacturing or processing facility registration number(s)
- List of ingredients, including fragrances, flavours and colours
Additional information may be necessary depending on the product and its manufacturing arrangements.
Our services
How can CE.way help?
CE.way assists cosmetic brands, manufacturers and distributors with FDA cosmetic product listing requirements. Our services include:
01
Preparation of cosmetic product listing information
02
Submission of product listings through the FDA's electronic system
03
Guidance on applicable MoCRA listing requirements
Additional support with US cosmetic regulatory compliance, labelling and facility registration is available upon request.
Related services
Related services
CE.way can offer various services related to MoCRA product listing. We can offer:
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Need assistance with MoCRA product listing?
Contact CE.way for professional assistance with FDA cosmetic product listing and other applicable MoCRA requirements.
