Introduction: A New Era in Cosmetic Regulations
U.S. beauty industry: the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Signed into law by President Biden on December 29, 2022, MoCRA marks the most significant update to cosmetics regulations since the Federal Food, Drug, and Cosmetic Act (FD&C) was enacted in 1938.
For consumers, MoCRA promises enhanced safety, transparency, and quality control. For cosmetic companies, it introduces stricter guidelines, mandatory reporting, and higher accountability.
In this guide, we’ll break down the key components of MoCRA, including registration, product listing, labeling, safety substantiation, and exemptions, to help your business comply with these transformative regulations.
1. FDA Registration & Product Listing Requirements
Facility Registration
Under Section 607 of MoCRA, all facilities manufacturing or processing cosmetics for the U.S. market must register with the FDA. This applies to both domestic and international facilities.
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- Existing Facilities: Must register by December 29, 2023.
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- New Facilities: Must register within 60 days of beginning operations.
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- Registrations must be renewed every two years.
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- Changes to facility information must be reported within 60 days.
Product Listing
Each cosmetic product must be listed with the FDA, detailing ingredients (including fragrance allergens), responsible parties, and the facility location.
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- Deadline: Existing products must be listed by December 29, 2023.
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- New Products: Must be listed within 120 days of introduction to the U.S. market.
2. Adverse Event Reporting
Under Section 605 of MoCRA, companies must maintain records of serious adverse events and report them to the FDA within 15 business days.
Expanded Definition of Serious Adverse Events:
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- Persistent or significant rashes.
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- Second- or third-degree burns.
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- Significant hair loss.
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- Disfigurement or alteration of appearance.
Adverse event reports must include updates for up to one year and be accessible via a U.S. address, phone number, or electronic contact information listed on product labels.
3. Labeling, Safety Substantiation, & GMP
Labeling Requirements
MoCRA mandates greater transparency in cosmetic labeling:
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- Fragrance Allergens: All allergenic ingredients must be disclosed.
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- Professional Use Products: Labels must specify if products are for licensed professionals only.
Safety Substantiation
Companies must validate the safety of cosmetic products through documented research, expert analysis, and scientific studies.
Good Manufacturing Practices (GMP)
MoCRA introduces federally mandated GMP standards to ensure product safety, with FDA guidance expected within two years of enactment.
4. MoCRA Exemptions
Smaller businesses may qualify for exemptions under MoCRA:
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- Eligibility: Businesses with gross annual sales under $1,000,000 USD over the last three years.
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- Exemptions: GMP compliance, facility registration, and product listing requirements.
However, exemptions do not apply to:
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- Products making contact with the mucous membrane of the eye.
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- Injectable cosmetics.
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- Internal-use cosmetics.
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- Long-lasting cosmetics altering appearance for more than 24 hours.
5. Enforcement Powers
MoCRA equips the FDA with enhanced enforcement tools:
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- Preemption: Federal regulations override any conflicting state or local laws, such as the California Safe Cosmetics Act.
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- Mandatory Recall Authority: FDA can enforce recalls for products deemed misbranded, adulterated, or posing health risks.
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- Facility Suspension: FDA can suspend a facility’s registration if its products pose a serious health risk.
6. Timeline for Implementation
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- December 29, 2023: Facility registration and product listing deadlines.
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- Within Two Years: GMP guidance issued.
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- Within Three Years: Final GMP guidance enacted.
How to Achieve MoCRA Compliance
MoCRA’s sweeping changes demand preparation and proactive compliance strategies. Registrar Corp has been assisting companies worldwide for over 20 years, helping them navigate FDA regulations with ease.
From facility registration and product listings to adverse event reporting and labeling reviews, our experts provide the guidance you need to ensure compliance with MoCRA.
MoCRA represents a monumental shift in the cosmetics industry, prioritizing consumer safety and transparency while holding companies accountable for compliance. By understanding the new requirements and acting now, your business can confidently navigate these regulations and thrive in the U.S. market.
