U.S. FDA Cosmetic Compliance Solutions

Registrar Corp assists over 30,000 companies each year across 190+ countries to achieve FDA compliance.
We know how to help you meet MoCRA requirements before FDA enforcement begins.

Facility Registration

We can help you achieve MoCRA compliance by registering your cosmetic facilities with FDA. We can also act as your U.S. Agent if your facilities are located outside the USA.

Product Listings

FDA cosmetic listings can be complicated to file. We help you save time, money, and the frustration of doing it yourself by making product listings quick and easy.

Adverse Event Reporting

Use Registrar’s Adverse Events Reporting Software to quickly and easily collect adverse event reports, get branded URLs or QR codes for your product label, and receive organized reports to review.

Label & Ingredient Review

MoCRA imposes new changes on how cosmetic product labels are handled. Our experienced team of labeling specialists make it easy for your company to remain compliant with all labeling regulations.

Cosmetic Formulation Software

Cosmetri empowers cosmetic and personal care product companies by accelerating product development, assuring compliance, and streamlining operations. 

Cosmetic Compliance Training

Become an expert in MoCRA and cosmetic GMPs. Our online training courses are built by industry experts to fit your busy schedule.

Hear From Our Industry Experts

Key Considerations for Exporters of Cosmetics and Beauty Care Products to the USA
On-Demand Webinar
10:00AM-11:00AM Singapore
Key Considerations for Exporters of Cosmetics and Beauty Care Products to the USA
This webinar conducted by Registrar Corp and Amazon will provide businesses seeking U.S. expansion insights on navigating new FDA requirements...
Unveiling the “Clean”: Navigate the Clean Beauty Movement with Confidence
On-Demand Webinar
12:00PM-1:00PM ET
Unveiling the “Clean”: Navigate the Clean Beauty Movement with Confidence
In this webinar, we unmask the complexities behind the booming “clean beauty” trend and discuss the regulatory and legal pitfalls...
Requisiti MoCRA per i prodotti cosmetici negli U.S.A.
On-Demand Webinar
Requisiti MoCRA per i prodotti cosmetici negli U.S.A.
Considerati i cambiamenti significativi nel panorama normativo, è essenziale che i professionisti del settore siano informati. Unitevi a noi per...

Frequently Asked Questions

MoCRA is the Modernization of Cosmetics Regulation Act of 2022 and was signed into law on December 29th, 2022. MoCRA is the largest reform of existing cosmetic regulations in the United States in 84 years and establishes many new requirements, such as:

  • Facility Registration
  • Product Listings
  • Good Manufacturing Practices (GMPs)
  • Safety Substantiation
  • New labeling requirements
  • Adverse Event Reporting
  • Record Keeping

Under MoCRA, the term “facility” includes any establishment that manufactures or processes cosmetic products distributed in the United States. Most facilities will need to register and comply with GMPs issued by FDA.

Find out which requirements your company will need to meet. Registrar Corp’s industry experts created the MoCRA Wizard to help companies determine which requirements they must meet. Answer a few short questions and in less than two minutes, know exactly which you’ll need to comply with and how we can help.

The term “responsible person” means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the cosmetic label.

The “responsible person” will be responsible for:

  • Cosmetic product listings
  • Adverse event reporting and record keeping
  • Safety substantiation
  • Labeling updates
  • Recalls
  • Fragrance allergen disclosures

Yes, small businesses will have more flexible and simplified requirements. FDA defines a small business as a business with average gross annual sales in the U.S. for the previous 3-year period of less than $1,000,000, adjusted for inflation. This does not apply to any responsible person or facility engaged in manufacturing cosmetic products that:

  • Come into contact with eyes,
  • Are injected,
  • Are intended for internal use,
  • Or alter the appearance for more than 24 hours under conditions of use that are customary or usual.

Wondering if you’re exempt? Find out if you’re exempt by answering a few questions using our MoCRA Wizard, developed by our industry experts to help you find out which, if any, requirements you must meet.

For existing facilities, facility registration and product listings are due by December 29, 2023. New facilities that manufacture or process cosmetic products for distribution in the U.S. must register within 60 days of marketing the product or 60 days after the deadline for existing facilities, whichever is later. 

MoCRA allows for flexible listings where companies can submit a single listing for cosmetic products with identical formulations or formulations that only differ with respect to colors, fragrances or flavors, or quantity of contents.

In the Draft Guidance, FDA announced that Cosmetics Direct will be using the same electronic submission system as drugs, meaning all listings will need to be submitted through the Structure Product Labeling (SPL Format). The SPL will require to list all shades, fragrance and quantity variations.

Not sure where to start? Our industry professionals created a simple tool to help companies determine which requirements apply to them. Answer a few short questions and in less than two minutes, the MoCRA Wizard will show exactly which requirements you must meet to maintain FDA compliance.

By December 29, 2023, companies must provide electronic contact information in which a responsible person can receive adverse event reports.

Cosmetic products that contain fragrance allergens must update their label to list those allergens. For professional cosmetic products, labels must indicate a clear and prominent statement that the product is administered or used only by licensed professionals and is in conformity with the existing cosmetic labeling requirements.

Learn more about adverse event requirements and how we can help you comply.

Within 1 year: Professional cosmetics product labels must include all required information and state that only licensed professionals may use the product.

Within 2 years: Labels must include responsible person’s contact information for adverse reporting and must identify fragrance allergens determined by FDA.

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