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Everything you need to know: Modernization of Cosmetics Regulation Act

What is the Moderzination of Cosmetics Act (MoCRA)?

The FDA Modernization of Cosmetics Regulation Act (MoCRA) legislation, which was signed into law in December 2022, is a major step forward in ensuring that cosmetic products are safe for consumers. This is the first significant update we’ve seen for cosmetic regulations since the Federal Food, Drug, and Cosmetic Act was established in 1938. Frankly, the industry was overdue for this kind of attention.


The legislation includes new regulations around ingredient safety, labeling requirements, and claims substantiation, which are all aimed at improving transparency and accountability in the cosmetic industry. While this is great news for the consumer, cosmetic brands will need to ensure they’re compliant with the new regulations. The registration requirements are set to be enforced on December 29, 2023, one year after MoCRA was enacted.



Keeping consumers safe

One of the most significant aspects of MoCRA is the new requirements around ingredient safety. Under the legislation, cosmetic companies are now required to provide the FDA with safety data for any new ingredients before they are allowed to be used in products. This will help to ensure that potentially harmful ingredients are identified and removed from cosmetic products before they reach the market.



Labeling requirements

In addition to ingredient safety, MoCRA also includes new labeling requirements for cosmetic products. New regulations require cosmetic companies to include a list of all ingredients on their products' labels, including any fragrances or flavors. This will make it easier for consumers to make informed decisions about the products they purchase and use. Under MoCRA, every facility that manufactures or processes cosmetic products for distribution must register with the FDA no later than December 29, 2023. It doesn’t matter if the company is domestic or foreign. New facilities must register within 60 days of starting manufacturing or processing operations.


Additionally, the manufacturer, packer, or distributor whose name appears on the label, which MoCRA defines as the “responsible person,” must list each cosmetic product and its ingredients with the FDA no later than December 29, 2023. After this date, the responsible person has 120 days to submit the product listing and keep it updated annually.



Claims substantiation

Finally, MoCRA includes new regulations around claims substantiation, which are aimed at ensuring that cosmetic companies can back up any claims they make about their products. Under the new regulations, companies will provide scientific evidence to support any claims they make about their products, and they must be able to substantiate these claims if challenged by the FDA or consumers. Scientific evidence includes tests, studies, research, analyses, or other evidence that is considered sufficient by scientific experts to certify the safety of the product.


These new regulations are incredibly important for consumers, who deserve to know that the cosmetic products they use are safe and effective. However, it's worth noting that the regulations have only just now been written into law, despite the fact that cosmetic safety has been a concern for many years. This is in part due to the fact that the cosmetic industry has historically been self-regulated, with little oversight from the FDA or other regulatory bodies.


Moving forward, we can expect to see more changes in the cosmetic industry as companies work to comply with the new regulations. In particular, we may see more companies turning to clinical trials and other research methods to ensure that their products are safe and effective and that they can back up any claims they make about their products.


This is where Citruslabs' CRO services come in. As a leading provider of clinical trial services for the cosmetic industry, we understand the importance of ensuring that products are safe and effective before they reach consumers. Our services can help cosmetic companies navigate the new regulations, including the requirements around claims substantiation, by providing them with the scientific evidence they need to back up their claims.


At the same time, we believe that it's important for consumers to be educated about the new regulations and the importance of choosing cosmetic products that have been through clinical trials or other rigorous testing methods. By choosing products that have been through these types of testing, consumers can feel confident that they are using products that are safe and effective, and that the claims made by the companies behind these products are backed up by scientific evidence.


The FDA Modernization of Cosmetics Act is an important step forward in ensuring that cosmetic products are safe and effective for consumers. The new regulations around ingredient safety, labeling requirements, and claims substantiation will help to improve transparency and accountability in the cosmetic industry, and we can expect to see more changes in the industry as a result.


At Citruslabs, we are committed to helping cosmetic companies navigate these changes by providing them with the clinical trial services they need to ensure that their products are safe and effective, and we believe that consumers have an important role to play in choosing products that have been through rigorous testing methods.


Want a free resource for complying with MoCRA? Get access to our recorded webinar with FDA Compliance Attorney Heather Bustos from Bustos Law Group.


In this webinar, we discuss:​​

  • ​The types of claims that are allowed and prohibited under MoCRA

  • ​Regulatory requirements for cosmetic products and claims under MoCRA

  • ​Tips for navigating the claims review process and ensuring compliance with MoCRA

  • ​Best practices for substantiating cosmetic claims through clinical trials

  • ​Real-world examples of cosmetic claims that have been challenged by regulators and how companies can avoid similar pitfalls




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