MoCRA Is Now in Effect. Is Your Cosmetics Brand Compliant?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant overhaul of federal cosmetics law since 1938. For the first time, the FDA has broad authority to require cosmetics manufacturers and distributors to register facilities, list products, report adverse events, maintain safety records, and follow Good Manufacturing Practices (GMP).
The registration and listing deadlines have passed. If your facility and products are not yet registered with the FDA, you are operating out of compliance — and enforcement is actively underway.
Capote Law Firm has been helping cosmetics companies navigate FDA compliance since 2006. We guide brands through MoCRA registration, product listing, safety substantiation, and adverse event reporting. Schedule a free consultation.
What MoCRA Requires
Facility Registration
Any person who owns or operates a facility that manufactures or processes cosmetic products for distribution in the United States must register with the FDA. Registration must be renewed biennially and updated within 60 days of any change to the registered information.
Who must register: domestic manufacturers, foreign manufacturers who ship to the U.S., and contract manufacturers producing cosmetics for U.S. distribution.
Who is exempt: retail establishments, beauty salons and spas, individual cosmetologists, and licensed health care professionals when cosmetics are used in their professional practice.
Product Listing
Responsible persons (typically the brand owner) must submit a product listing to the FDA for each cosmetic product. The listing must include the product name and category, list of ingredients (using INCI names), name and contact information of the responsible person, and facility registration number(s). Product listings must be updated annually and whenever the formulation changes.
Serious Adverse Event Reporting
Responsible persons must report serious adverse events associated with a cosmetic product to the FDA within 15 business days of receiving a report. A “serious adverse event” includes events resulting in death, life-threatening injury, inpatient hospitalization, persistent disability, congenital anomaly, or medical intervention to prevent serious outcomes. All adverse event records must be maintained for 6 years.
Safety Substantiation
Under MoCRA, cosmetic products must have adequate substantiation of safety. The responsible person must be able to demonstrate that the product and its ingredients are safe under the intended conditions of use.
Good Manufacturing Practices (GMP) — Coming Soon
The FDA is required to issue binding GMP regulations for cosmetics. These are expected to align closely with the voluntary ISO 22716 GMP standard. Companies that have already implemented ISO 22716 will have a significant advantage when the rules take effect. Capote Law Firm can help you assess your current GMP posture and begin closing gaps now.
Who Is Responsible Under MoCRA?
MoCRA distinguishes between responsible persons (typically the brand owner or distributor) and facility owners/operators (typically the contract manufacturer). Both have independent obligations:
- Responsible persons: product listing, safety substantiation, adverse event reporting, labeling compliance
- Facility owners/operators: facility registration, record maintenance, GMP compliance
If you are a brand owner using a contract manufacturer, both you and your manufacturer have separate registration and compliance obligations.
Consequences of Non-Compliance
- Warning letters citing specific MoCRA violations
- Mandatory recall authority — the FDA can now order cosmetic recalls under MoCRA
- Injunctive relief and product seizure
- Civil penalties for failure to report serious adverse events
- Import detention for unregistered foreign manufacturers
How Capote Law Firm Helps Cosmetics Brands
- MoCRA compliance audit: We review your registration status, product listings, labeling, safety documentation, and adverse event procedures.
- Facility registration assistance: We guide you through the FDA’s Cosmetics Direct system to complete or correct your registration.
- Product listing: We compile and submit accurate product listings with complete ingredient statements and required metadata.
- Adverse event reporting program: We help you establish an internal process for identifying, documenting, and reporting adverse events within the 15-business-day window.
- Safety substantiation review: We assess your current safety files and identify gaps before an FDA inspection.
- GMP readiness: We evaluate your practices against ISO 22716 and upcoming FDA GMP requirements.
Frequently Asked Questions
My contract manufacturer registered our facility. Am I covered?
No. Facility registration is the manufacturer’s obligation, but product listing and adverse event reporting are the responsible person’s (brand owner’s) obligation. Both parties have independent duties under MoCRA.
Do small brands need to comply?
MoCRA exempts businesses with average gross annual U.S. sales of $1 million or less from facility registration. However, these businesses are still subject to safety substantiation, adverse event reporting, and labeling requirements. Most growing cosmetics brands exceed the threshold or are approaching it.
We sell on Amazon and Etsy. Does MoCRA apply to us?
Yes. If you are selling cosmetic products in the U.S. through any channel — including online marketplaces — MoCRA applies. Third-party platforms are not a shield from FDA enforcement.
What if our foreign manufacturer is not registered?
The FDA can detain products imported from facilities that are required to register but have not done so. Capote Law Firm can assist foreign manufacturers navigate the U.S. registration process.
Need a MoCRA compliance review? Call (786) 207-1174 or schedule your free consultation. We work with cosmetic brands and manufacturers nationwide.