What Is MoCRA? A Complete Guide to the New U.S. Cosmetic Law

The beauty and skincare industry in the U.S. is undergoing its most significant regulatory change in decades.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) expands the FDA’s authority over cosmetics, introducing new safety, labeling, and reporting requirements.

Whether you’re a large skincare brand or an indie beauty company, understanding MoCRA is critical to staying compliant and protecting consumers.

What Is MoCRA?

The Modernization of Cosmetics Regulation Act (MoCRA) was signed into law in December 2022 to update U.S. cosmetic regulations, which had remained largely unchanged for over 80 years.

It gives the Food and Drug Administration (FDA) more oversight authority over cosmetics and skincare products.

MoCRA’s goal is to enhance consumer safety, improve product transparency, and ensure that cosmetic products are manufactured, labeled, and marketed responsibly.

Who Must Comply With MoCRA

MoCRA applies to a broad range of entities in the cosmetics supply chain, including:

• U.S. cosmetic manufacturers
• Contract manufacturers
• Importers
• Distributors
• Brands / private label companies

Even small or independent brands must comply.

Any company producing, selling, or distributing cosmetic products in the U.S. is required to follow MoCRA rules.

Key Requirements of MoCRA

MoCRA introduces several new requirements for cosmetic companies.

Here’s a breakdown of the most important ones:

3.1 Facility Registration

All cosmetic manufacturing facilities in the U.S. must register with the FDA.

Registration must be renewed every two years and provides the FDA with information about the facility location and responsible parties.

3.2 Product Listing

Brands are required to list all cosmetic products with the FDA, including:

• Product name
• Complete ingredient list
• Manufacturing facility
• Responsible person or brand owner

This ensures the FDA has a complete database of cosmetics sold in the U.S.

3.3 Safety Substantiation

Cosmetic companies must maintain evidence that products are safe for consumers.

Acceptable safety documentation can include:

• Formulation testing results
• Toxicology reports
• Other scientifically sound safety data

This does not require pre-market FDA approval, but the safety evidence must be ready in case of inspection.

3.4 Adverse Event Reporting

Brands must report “serious adverse events” to the FDA within 15 days.

Examples include:

• Hospitalization
• Severe allergic reactions
• Burns, infections, or injuries caused by a cosmetic product

This requirement helps the FDA monitor product safety and protect consumers.

3.5 Good Manufacturing Practices (GMPs)

MoCRA requires cosmetic facilities to adhere to FDA-enforced Good Manufacturing Practices.

This includes proper sanitation, quality control, and record-keeping to ensure product safety and consistency.

3.6 Updated Labeling Requirements

MoCRA updates labeling rules for cosmetic products, including:

• Allergen disclosure, especially for fragrance allergens
• Contact information for reporting adverse reactions
• Clear labeling for professional-use products

These changes aim to improve transparency and help consumers make informed choices.

MoCRA Penalties for Non-Compliance

Companies that fail to comply with MoCRA face serious consequences:

• The FDA can suspend facility registration, blocking distribution.
• Mandatory recalls may be enforced for unsafe products.
• Civil and criminal penalties may apply for severe violations.

Non-compliance can significantly disrupt a brand’s operations and reputation.

How MoCRA Impacts the Beauty and Skincare Industry

MoCRA introduces a higher level of oversight and responsibility for cosmetic brands:

• Higher safety and manufacturing standards
• Increased compliance costs for facilities, testing, and record-keeping
• Greater transparency for consumers regarding ingredients and product safety
• Marketing implications, as claims must be truthful and substantiated

Overall, MoCRA aims to protect consumers while raising industry standards for all cosmetic products sold in the U.S.

What MoCRA Does Not Change

Despite these new rules, MoCRA does not:

• Require FDA pre-market approval of cosmetic products (except certain color additives)
• Change the distinction between cosmetics and drugs
• Affect sunscreens, acne treatments, or other OTC products regulated separately

Brands should still follow all other applicable FDA rules while implementing MoCRA compliance.

Compliance Tips for Cosmetic Brands

Keeping your beauty brand MoCRA-compliant doesn’t have to be overwhelming.

Here are some easy-to-follow steps:

1. Register Your Facility: Make sure all your manufacturing locations are registered with the FDA and keep info up to date.
2. List Your Products: Submit every product and ingredient list to the FDA and update whenever things change.
3. Document Safety: Keep proof that your products are safe—like testing reports or scientific data.
4. Track Adverse Events: Have a system to record and report serious reactions within 15 days.
5. Follow GMPs: Keep your production clean, organized, and consistent with FDA standards.
6. Check Labels & Claims: Clearly list allergens, add contact info, and make sure marketing claims are honest.

Even small steps can go a long way in staying compliant and keeping customers safe!

Consumer Perspective

For shoppers, MoCRA is good news.

The law is designed to make cosmetic products safer, more transparent, and easier to trust.

• Safety First: Serious adverse events are tracked and reported, helping prevent unsafe products from staying on shelves.
• Clearer Labels: Allergens, contact info, and professional-use details are easier to find.
• Peace of Mind: Consumers can feel confident that brands are keeping safety records, following GMPs, and playing by the rules.

MoCRA Requirements Summary Table

Resources and References

Here are some helpful links and organizations to keep handy:

• FDA MoCRA Info: FDA Cosmetics Laws & Regulations
• Facility Registration & Product Listing: FDA Cosmetic Registration
• Adverse Event Reporting: FDA MedWatch

These resources make it easier to stay on top of the rules without feeling lost.