FDA MoCRA Compliance for Your Cosmetics Products

We assist manufacturers, importers, and distributors of cosmetic products with cosmetic safety assessments, regulatory support, cosmetic label design and compliance. Our experts can review your artwork and help prepare a fully compliant, print-ready art file to enable you to bring your cosmetic products to market without compromising compliance.

We will help you understand the complex requirements of MoCRA and ensure that your products meet the new standards.

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The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, marks a significant overhaul of the cosmetics regulatory framework in the United States. MoCRA aims to enhance consumer safety by introducing stricter regulations for the manufacturing, distribution, and safety assessment of cosmetic products.

By adhering to the FDA MoCRA cosmetics requirements and following the FDA’s guidelines, cosmetic manufacturers and distributors can play a crucial role in maintaining the safety and quality of cosmetic products for consumers and adhering to FDA cosmetic labeling requirements. For MoCRA compliance, companies can rely freely on Quality Smart Solutions for the best services and assistance in obtaining the compliance.

Comply with FDA’s new cosmetic regulations quickly and easily.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) gives U.S. FDA greater control and oversight of the cosmetic industry. Many regulations, including FDA cosmetic registration, go into effect December 29th, 2023.

FDA Requirements to Meet MoCRA Compliance

Compliance Policy for Facility Registration and Cosmetic Product Listing Requirements

The cosmetic labeling requirements FDA guideline outlines the procedures for facility registration and product listing, including deadlines, submission methods, and data requirements.

Good Manufacturing Practices for Cosmetic Products

The FDA cosmetics labeling guide also outlines the FDA's expectations for GMPs in cosmetic manufacturing, covering topics such as sanitation, quality control, and labeling.

Mandatory Adverse Event Reporting for Cosmetic Products

The cosmetic labelling regulations explains the mandatory adverse event reporting requirements under MoCRA, including reporting criteria, timelines, and submission procedures.

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.

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.

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.

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.

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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Edward Ro Amazing Grass

I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.

Michael T MT Consulting

I've used QSS services for many years now and they always deliver a very professional service. Everyone on the team is great to work with and they always come up with great solutions for your needs a great price!

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Connect with MoCRA Compliance Experts

Wondering how to comply with MoCRA, the new cosmetics law & cosmetic labelling regulations?

Quality Smart Services is here to help. Our experts will guide you through every step, from registering your facilities to reporting any product issues. With us on your side, you can focus on making great cosmetics while we handle the compliance details.

Please fill up the Inquiry form to book your free consultation session.

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