It’s been a year and a half since the Modernization of Cosmetic Regulations Act of 2022 (MoCRA) was passed. Let’s see where things stand!
Safety Substantiation
Fully in effect
The company whose name is on the label (the “responsible party”) must have suitable and scientifically acceptable substantiation that the product is safe. The substantiation could be testing of the product or previous studies or information that the ingredients are all safe or that similar products have been proven safe.
Severe Adverse Event Reporting
Fully in effect
Effective June 29, 2024, the label of a cosmetic product must include contact information for receiving adverse event reports. The contact may be a domestic address, so if the full address (including the street) is on the label, this requirement is met. If the street address has been omitted (as per the allowances of other regulations) then there must be some other contact information such as a phone number, email, or website.
The responsible party must report any severe adverse event connected to the use of a cosmetic product for which their name is on the label. Detailed records must be kept.
To make a serious event report, currently the FDA recommends downloading and filling in Form 3500A and submitting it by email to [email protected] or by mail to FDA CDER Mail Center, Attn: Cosmetics MedWatch Reports, White Oak Campus – Building 22 – G0207, 10903 New Hampshire Ave., Silver Spring, MD, 20993.
Fragrance Allergens
Waiting on FDA Action (was due on June 29, 2024)
MoCRA requires that fragrance allergens are included on the label of each cosmetic product, but did not specify which allergens had to be listed.
The FDA was given 18 months (until June 29, 2024) to publish the proposed regulations, including the list of allergens and the threshold amounts. Then they had 6 months from the end of the comment period to issue the final regulations, which should include the effective date (the date by which you must comply).
So far they have not yet published the proposed regulations.
Professional Use
Fully in effect
Cosmetics for professional use must have the full ingredient declaration on the package and include a clear and prominent statement that the product shall be administered or used only by licensed professionals.
Under MoCRA, “professional” means someone who is officially licensed by a state to practice cosmetology, nail care, barbering, or esthetics.
Facility Registration & Product Listing
Fully in effect
Facility registration is now required (as of July 1st 2024) for any cosmetic manufacturer that is not exempt as a small business. The manufacturer is responsible for registration. New businesses must register within 60 days (2 months) of starting the business.
Product listing is now required (as of July 1st 2024) for any cosmetic product being sold. The person or company named on the label is responsible for completing the product listing. New products must be listed within 120 days (4 months) of being marketed.
The FDA has set up Cosmetics Direct, an online portal for manufacturer registration and product listing. It’s pretty straightforward; there is a good User Guide and tutorials are available. The only tricky point is that you must request and receive a Federal Entity Identification (FEI) Number before you can register a cosmetic facility. Information on how to request an FEI can be found on the FEI Portal FAQ (6th question down).
The small business exemption applies to companies which have less than $1 million annual revenue (average over the last 3 years) AND which do not make/sell internal or injectible cosmetics, cosmetics that come in contact with the mucous membrane of the eye, or products which stay on the body and alter the appearance for more than 24 hours and are intended to be removed by a professional.
Good Manufacturing Practices
Waiting on FDA Action (due by December 29, 2024)
Any Cosmetic manufacturer that is not exempt as small business will need to comply with Good Manufacturing Practices (“GMP”). The FDA has draft guidelines for GMP now, but MoCRA requires that they publish proposed regulations for GMP by December 29, 2024, and the final regulations must be published by December 29, 2025.
Of course if you are making cosmetics (regardless of the size of your operation) you should have sufficient GMP (good procedures and practices) in place to ensure that your products are safe, and are not adulterated or contaminated!
Additional FDA Authority
Fully in effect
The FDA now has the authority to require a product recall if they deem the product to be a threat to the health and safety of consumers. There is a whole set of procedures covering how that process works.
The FDA now has the right to inspect and copy records relating to a cosmetic product if they believe the product or an ingredient is or may be a threat to the health or safety of consumers. There are procedures for doing so, and the records they can inspect do not include product recipes or formulations, financial data, pricing data, personnel data (except to determine suitable qualifications), research data, or sales data.
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