MoCRA: What Brands Need to Know
MoCRA (Modernization of Cosmetics Regulation Act of 2022) brings significant changes to the cosmetics industry in the US. Here's a breakdown of the key things brands need to know.
On December 29th, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) into law, which included the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
MoCRA added Section 607 to the Federal Food, Drug, and Cosmetic Act (FD&CA) to establish requirements for cosmetic product facility registration and product listing. It enhances the FDA's authority, establishes a uniform national framework, and promotes safety and innovation.
Cosmetic brands and manufacturers who have distributed or marketed cosmetic or personal care products in the U.S. on December 29, 2022 and after have requirements to be made by the FDA that are currently active TODAY!
The Key Elements of MoCRA
Mandatory Facility Registration
Cosmetic Product Listing
Adverse Event Reporting
Cosmetic Safety Substantiation
Good Manufacturing Practices (GMPs)
Fragrance Allergen Labeling
Records Access
Mandatory Facility Registrations
Who: Facilities that manufacture or process cosmetics in the US for distribution in the US market. This includes contract manufacturers and packers.
What: Register with the FDA and renew registration every two years.
When: Registration opened on December 29, 2023. Enforcement begins July 1, 2024
Cosmetic Product Listing
Who: Brands (or the "responsible person") for each cosmetic product.
What: Submit a listing of each product to the FDA, including ingredients, manufacturing information, and more. Update annually.
When: Listing can begin on December 29, 2023. Enforcement begins July 1, 2024.
Adverse Event Reporting
Who: The "responsible person" for a cosmetic product.
What: Track and report any adverse health events associated with your product to the FDA within 15 business days.
When: This requirement is effective December 29, 2023.
Cosmetic Safety Substantiation
Who: The "responsible person" for a cosmetic product.
What: Track and report any adverse health events associated with your product to the FDA within 15 business days.
When: This requirement is effective December 29, 2023.
Good Manufacturing Practices (GMPs)
Who: Facilities that manufacture or process cosmetics.
What: Comply with GMP regulations established by the FDA. These will likely cover aspects like sanitation, record-keeping, and quality control.
When: The FDA is currently developing these regulations.
Fragrance Allergen Labeling
Who: Brands
What: Label cosmetic products with any fragrance allergens identified by the FDA. The FDA has not yet identified fragrance allergens for the label.
When: Pending FDA guidance on Fragrance Allergens to declare.
Records Access
Who: Brands and Facilities
What: Maintain records related to product safety substantiation, adverse events, and GMP compliance. Make these records available to the FDA upon request.
When: This requirement is effective as of December 29, 2023.
Cosmetic Labeling (for Professional Use Products)
By December 29, 2023, products intended solely for professional use must clearly be labeled, indicating they can only be administered or used by a licensed professional. Further, the professional use product requires compliance with MoCRA labeling requirements and section 4(a) of the Fair Packaging and Labeling Act.
One of the previous loopholes in the FD&CA was “for professional use only” cosmetic products did not require ingredients to be listed on the label. In 2018, California Bill AB 2775 was signed into law, making it the first state in the nation to mandate ingredient labeling for professional salon products.
This legislation played a significant role in influencing the inclusion of a similar provision in MoCRA. As a result, salon workers have the right to access ingredient information on product labels, promoting awareness of the substances they are exposed to while working.
Mandatory Recall / Cease Distribution Authority
As of December 29, 2023, FDA has new authorities. FDA can access and copy certain records related to a cosmetic product, including safety records. In the event “the agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of or exposure to the cosmetic will cause serious adverse health consequences or death, FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily.”
This significant new authority allows FDA greater ability to regulate cosmetics in the U.S.
FDA will provide the Responsible Person with an opportunity to voluntarily cease distribution of or recall the cosmetic product before issuing a mandatory recall. A Responsible Person can appeal this in a requested informal hearing prior to a mandatory recall.
FDA may suspend a Facility’s registration, requiring the Facility to cease distribution of all cosmetic products, if FDA:
(1) Determines a cosmetic product manufactured or processed by the Facility has a “reasonable probability” of causing serious adverse health consequences; and
(2) Reasonably believes that “other products manufactured or processed by the Facility may be similarly affected” due to an unidentified or pervasive issue that could affect other products.
Before suspending a Facility’s registration, FDA will provide notice and an opportunity for the Facility to be heard at an informal hearing. A suspended Facility must submit a corrective action plan to FDA covering how it will address the issue, but a Facility’s registration will be reinstated only once FDA determines “adequate grounds do not exist to continue the suspension actions.”
It is recommended to review your current policies and procedures in light of this new authority. Implementing best practices can help avoid a future product recall and, potentially, significant civil penalties.
Claire Bing is CEO and Founder of Confiance Cosmetic Group LLC, a consulting agency helping cosmetic brands and manufacturers launch compliant products globally. If you have any questions or comments regarding this article, MoCRA, or other US or international legislation regarding cosmetics, please reach out to Claire at claire.bing@confiancecosmetic.com.
LAST UPDATED OCTOBER 1, 2024
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