Modernization of Cosmetics Regulation Act of 2022
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics and is the first major amendment to the Federal Food, Drug, and Cosmetics Act (FDCA) since its enactment in 1938. This new law will fundamentally change the way cosmetics are regulated in the US and help ensure the safety of cosmetic products many consumers use daily.
Among the new and changed requirements are:
- Mandatory Facility Registration and Product Listing Section 607
- Mandatory Good Manufacturing Practice Requirements (GMPs) Section 606
- Mandatory Adverse Event Reporting Section 605
- Records Access and Inspections Section 610
- Mandatory Safety Substantiation
- Expanded Labeling Requirements
- New Enforcement Authorities
Do You Have Questions on How to Comply with the Regulation or Need Help Making Sure You’re Ready for These New Requirements?
The EAS Consulting Group team of experts are available to provide consultation services on adverse events, GMPs, facility registration, product listing, safety substantiation, labeling, and more. We also provide assistance with evaluating the safety of your formulation, label reviews, submission of color additive petitions, and determining if your product is cosmetic, OTC drug, or cosmetic/drug combination.
MoCRA Establishes the Following New Requirements
Adverse Event Reporting
A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days.
Facility Registration
Manufacturers and processors must register their facilities with FDA and renew their registration every two years.
Product Listing
A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and renew or provide any updates annually.
Safety Substantiation
It is a legal requirement for companies and individuals who manufacture or market cosmetics to ensure that their products are safe under the recommended conditions of use.
MoCRA Also Requires That Industry Comply With Regulations That FDA Will Establish For
GMPs
Good Manufacturing Practice requirements for facilities that manufacture cosmetic products.
Labels
Labeling requirements for fragrance allergens.
MoCRA Provides New Authorities to FDA Including
Records Access
If certain conditions are met, FDA can access and copy certain records related to a cosmetic product, including safety records.
Mandatory Recall Authority
If certain conditions are met, FDA can access and copy certain records related to a cosmetic product, including safety records.
Am I Expempt from MoCRA?
MoCRA exempts certain small businesses from GMP, registration, and product listing requirements.
However, such exemptions do not apply to manufacturers or facilities that manufacture or process the following cosmetic products:
- Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.
- Products that are injected.
- Products that are intended for internal use.
- Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.
Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.
Key Terms
Facility
A facility is any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.
Responsible Person
A responsible person can include the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product.
Adverse Event
An adverse event is any health-related event associated with the use of a cosmetic product that is adverse.
Serious Adverse Event
A serious adverse event is an event that:
- (A) results in: death; a life-threatening experience; inpatient hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect; an infection; or significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual; or
- (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in (A) above.
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