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FDA Modernization of Cosmetic Regulations Act Compliance

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.

The Modernization of Cosmetic Regulation Act is a new law 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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Why do we need the new MoCRA Cosmetic Regulations?

Every cosmetic product needs to be manufactured, packaged, and stored under hygienic and healthy conditions. The FDA  imposes a penalty on manufacturers if they misbrand or adulterate commodities, or package their products inappropriately. Manufacturers or importers must carry a safety assessment before marketing their cosmetic products.

Cosmetic Labels
Cosmetic Labelling Regulations

Your products must meet cosmetic labelling regulations i.e. Federal Food, Drug, and Cosmetic Act and Fair Packaging and Labeling Act in USA.

Product Location Inspection

The authority inspects locations where companies manufacture or store their cosmetic products. The agency also monitors advertising or labelling material related to products.

Mandatory Information

Product identification, net quantity declaration, and identity and location of business of the dealer must appear on the label of a pre-packaged cosmetic.

Warning & Legal Action

If the cosmetic product is misbranded or adulterated by manufacturers or importers, the FDA can issue a warning letter followed by taking a legal action depending on the case.

Cosmetic Regulations in the USA

Cosmetics are products that are professionally made for cleansing and improving the complexion, skin, hair, or teeth. These products fall under US cosmetic regulations. Some common cosmetics are skincare products, fragrances, hair, and manicure products.

In the USA, the revenue from the Cosmetic Industry is approximately 49.2 billion US dollars. It is the most valuable beauty and personal care market in the world. Complying with the regulations is key, beginning with the cosmetic product development stage all the way to market execution is essential.  

FDA cosmetic regulations

What is MoCRA?

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.

How does MoCRA impact cosmetic product manufacturers?

The Modernization of Cosmetic Regulation Act significantly impacts cosmetic product manufacturers. Under the new law, manufacturers are required to 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. Additionally, 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

What are the new safety standards for cosmetic products?

The Modernization of Cosmetic Regulation Act also includes new safety standards for cosmetic products. Manufacturers are now required to report any serious adverse events related to their products to the FDA within 15 business days. They must also follow Good Manufacturing Practices (GMPs) to ensure the safety and quality of their products. These GMPs include requirements for personnel, facilities, equipment, and processes used in the manufacturing, packaging, labeling, and storage of cosmetic products. By implementing these new safety standards, the FDA aims to protect consumers from harmful or unsafe cosmetic products.

What are the new requirements for ingredient labeling?

Under the Modernization of Cosmetic Regulation Act, cosmetic product manufacturers are required to list all ingredients on the product label in order of predominance. This means that the ingredient that makes up the highest percentage of the product must be listed first, followed by the next highest percentage, and so on. Additionally, any fragrance or flavor ingredients must be listed separately, and any color additives must be listed by their respective names. These new labeling requirements provide consumers with more transparency about the ingredients in the products they use and help them make more informed purchasing decisions.

FDA cosmetic regulations cosmetic products
Cosmetic Labeling Requirements

Comply with Registration and Compliance Filing Rules, Advertising and Testing

All cosmetic manufacturers and importers must register with the FDA every year, as well as file for product compliance. This is to ensure that cosmetic products comply with the FD&C (Food, Drug and Cosmetic) Act in terms of safety and labeling regulations. Companies should also make sure that their products are listed in the FDA’s Voluntary Cosmetic Registry Program (VCRP) database, which enables easier identification with the regulatory agency. 

All advertising for cosmetics must meet the requirements of the FDA, including making sure there are appropriate disclaimers in each advertisement. In addition to this, these products must also maintain standards of purity and quality when it comes to ingredients and final product testing. Manufacturers should be familiar with the relevant regulations regarding claims and tests they are required to conduct prior to releasing their products into the market.

Solutions for USA Cosmetic Regulations

We provide two label compliance services when it comes to USA Cosmetic Label Compliance. In our basic label compliance service, our regulatory team will review your artwork and give suggestions. In our design conversion label compliance service, our graphic designer and regulatory team will assist you in preparing a fully compliant, print-ready art file. We can help you adhere to cosmetic regulations, warning & legal action, product location inspection, and any other mandatory information. 

Cosmetic Labels

How can consumers stay informed about the MoCRA changes?

Consumers can stay informed about the changes brought about by the Modernization of Cosmetic Regulation Act by keeping up to date with the FDA’s website and social media channels. The FDA regularly updates its website with information about new regulations and any changes that may affect consumers. Additionally, consumers can sign up for email alerts from the FDA to receive notifications about new safety alerts, recalls, and other important information related to cosmetic products. It’s also important for consumers to read product labels carefully and to research the ingredients in the products they use to ensure they are safe and effective.

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.

5 Star Google Reviews
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

When will the new MOCRA requirements be put into effect?

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.

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