Comply with the Updated MoCRA Cosmetic Regulations by FDA

We assist manufacturers, importers, and distributors of cosmetic products with cosmetic safety assessments, regulatory support, and 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.  

MoCRA is a new law that came into effect on December 29, 2023 that aims to improve the safety and transparency of cosmetic products in the United States. We can assist with the changes brought about by the act and what it means for consumers and manufacturers of cosmetic products. 

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What is MoCRA?

MoCRA or the Modernization of Cosmetics Regulation Act of 2022, is a new law that was signed into law in December 2019. The act aims to modernize the regulation of cosmetic products in the United States by giving the FDA more authority to regulate cosmetic products and ingredients.  

mocra cosmetics Labels

How does MoCRA Impact Cosmetic Product Manufacturers?

The Modernization of Cosmetic Regulation Act significantly impacts cosmetic product manufacturers. Under the new law, manufacturers must register their facilities with the FDA and provide the agency with a list of all cosmetic products they manufacture. They must also report any serious adverse events associated with their products to the FDA within 15 days of becoming aware of the event.  

Plus, the FDA has the authority to order a recall of a cosmetic product if it is found to be unsafe or misbranded. Manufacturers must also comply with new labeling requirements, including listing all ingredients on the product label in order of predominance. Overall, the act places greater responsibility on cosmetic product manufacturers to ensure the safety and transparency of their products. 

FDA cosmetic regulations

Need Help with MoCRA Compliance Solutions?

We offer everything you need to meet MoCRA requirements, from listing your product and registering your facility to providing a US agent for your manufacturing site. We’ll help prove the safety of your cosmetic product and its ingredients, assist with reporting adverse reactions, and manage recalls if needed. Below are our sought-after MoCRA solutions. 

Product Listing

Through the FDA's secure online portal we list your cosmetic and all its variant submitting various required information.

Facility Registration

We will register your facility (please ensure you have a DUNS number) with FDA and, if your facility is outside the United States, act as your US Agent.

MoCRA Label Compliance

We review your label based on MoCRA and ensure all the necessary elements and content adheres to the new regulations.

Safety Substantiation

We will gather all the safety data related to your cosmetic product ingredients from various sources such as any of your data as well as publicly sourced and prepare a comprehensive report.

Manufacturer Facility Inspection

MocRA requires manufactures comply with GMP. If you require a pre-audit (before FDA inspects your site) or have us present during FDA's inspection we can support your GMP compliance needs.

Adverse Event Reaction Reporting

FDA requires all cosmetic adverse event reporting within 15 days of the incident being reported. We can support you with gathering the necessary information and filing with FDA.

Hear from Some of Our Amazing Clients

Proven Expertise. Companies that have placed their trust in us to meet the cosmetic regulations in the United States.

Shams W.Pawel Amazing Grass

“We’ve worked with Andrew and the QSS team for 5 years and they’ve always been very knowledgeable and professional. They’re a tremendous partner to have when dealing with Health Canada compliance regulations and will always work with you to come up with the best solutions.”

Michael MT Consulting

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.

Donal Gauvreau Sapro

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 the always come up with great solutions for your needs at a great price!

Frequently Asked Questions

There is no fee associated with cosmetics in the USA.
  • A U.S. address,
  • A U.S. phone number, or
  • Electronic contact information for receiving adverse event reports

Cosmetic products containing fragrance allergens must update labels to list these allergens. Professional cosmetic products must prominently indicate that they are to be used solely by licensed professionals and are compliant with existing cosmetic labeling norms.

If you need help with any of these steps let us know by emailing info@qualitysmartsolutions.com.

Cosmetic claims include texts, images or symbols that are used by brands to present the characteristics of a cosmetic product and are a real advertising tool for customers.  Under the Federal Food, Drug and Cosmetic Act (FD&C Act) cosmetics must not be misbranded.  For example, all cosmetic products must be safe for consumers by being properly labelled with the customary conditions of use.

The following ingredients are prohibited from being used in cosmetic products: mercury compounds, vinyl chloride, bithionol, halogenated salicylanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants and hexachlorophene.

The Modernization of Cosmetic Regulation Act is a new law that was signed into law in December 2019. The act aims to modernize the regulation of cosmetic products in the United States by giving the FDA more authority to regulate cosmetic products and ingredients. The act also requires cosmetic manufacturers to register their facilities with the FDA and to report any serious adverse events associated with their products. Overall, the act is designed to improve the safety and transparency of cosmetic products in the US.

The HHS secretary may suspend registration if severe adverse health effects or deaths are possible. Registrants must submit a corrective action plan for review, with facility suspension leading to restrictions on product introduction or delivery.

Records must be accessible to authorized personnel for product examination if there are concerns about product adulteration or ingredient safety. However, certain types of data, such as recipes or financial information, are exempt from review.

The HHS secretary is required to propose and finalize GMP regulations within two to three years after the enactment of MoCRA, ensuring compliance and product safety.

Failure to comply with registration and listing requirements may result in suspension of registration by the HHS secretary, prohibiting the introduction or delivery of cosmetic products from the suspended facility.

MoCRA promotes transparency and accountability by mandating reporting of adverse events, registration of cosmetic entities, and accessibility of records for product examination, thereby enhancing consumer safety and confidence.

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