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Your Guide to the Modernization of Cosmetics Regulation Act (MoCRA): What Is It and How Will it Affect Your Company?

Your Guide to the Modernization of Cosmetics Regulation Act (MoCRA): What Is It and How Will it Affect Your Company?

The beauty industry is one of the fastest-growing industries worldwide, with the global cosmetics market size estimated to be worth $805.61 billion by the end of 2023. The United States alone is one of the biggest contributors to this market. However, with the rise in the demand for beauty products comes the need for better regulation to ensure safety and efficacy. To address this concern, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was introduced. This bill aims to strengthen the regulation of cosmetics by updating the Federal Food, Drug, and Cosmetic Act, which governs cosmetic regulation.

Managing new regulations can be difficult, so we created this guide to help you simplify this process. In this guide, we’ll walk through what the MoCRA consists of and discuss how it will affect both cosmetics companies and the contract manufacturers who supply their raw materials. Read on to learn more.

What is MoCRA?

This new regulatory act seeks to enhance the oversight of the cosmetic industry by introducing new requirements for cosmetic manufacturers, packagers, and distributors. Some of the key provisions of this bill include:

  • Ingredient safety
    Under the MoCRA, cosmetic ingredients will have to undergo rigorous safety testing before being allowed in cosmetic products. This means that cosmetic companies will have to provide safety data for all ingredients used in their products. This information will be submitted to the FDA for review, and any ingredient found to be unsafe will be banned.
  • Registration of cosmetic facilities
    All cosmetic manufacturers and packagers will be required to register their facilities with the FDA. This will ensure that the FDA has accurate information on the number of facilities producing cosmetics in the country.
  • GMPs
    The MoCRA requires cosmetic companies to follow good manufacturing practices (GMPs) to ensure the safety and quality of their products. This includes maintaining proper documentation, ensuring hygiene and cleanliness in facilities, and implementing quality control measures.
  • Recall authority
    The FDA will have the authority to order a mandatory recall of any cosmetic product that is found to be harmful or defective. This will ensure that dangerous products are removed from the market promptly.

As a Cosmetics Supplier, How Will MoCRA Impact Your Company?

As the root of the supply chain, cosmetics suppliers will be heavily affected by this regulation. Here are some of the potential effects of this bill:

1) New ingredient testing requirements
One of the primary impacts of MoCRA on cosmetic suppliers and contract manufacturers is the new ingredient testing requirements. The law mandates that cosmetic ingredients must undergo safety testing before they can be used in any product. This testing must include both short-term and long-term safety evaluations. Suppliers and manufacturers must conduct the testing or rely on independent laboratories to perform the tests. The increased testing requirements are likely to increase costs and time for cosmetic suppliers.

2) Strengthened labeling requirements
MoCRA strengthens the labeling requirements for cosmetics. Manufacturers must now list all ingredients on the product label, including fragrance and flavoring components. This will increase transparency and allow consumers to make informed decisions about the products they buy. Suppliers and manufacturers will have to make sure that the labeling requirements are met, which may require changes to product packaging and labeling.

3) Mandatory reporting of adverse events
Another impact of MoCRA is the mandatory reporting of adverse events associated with the use of cosmetic products. Manufacturers must report any adverse events to the FDA within 15 days of becoming aware of the issue. This requirement may increase the burden on suppliers and manufacturers to monitor and report any issues with their products.

4) Increased FDA authority
MoCRA gives the FDA increased authority to regulate cosmetics. The FDA can now issue orders to stop the sale of cosmetics that are deemed to be unsafe. The agency can also require recalls of cosmetic products and impose civil penalties for violations of the law. This increased regulatory authority may lead to more inspections of cosmetic suppliers and contract manufacturers to ensure compliance with the law.

As a Cosmetics Company, How Will MoCRA Impact Your Company?

While suppliers will take the brunt of the regulation changes, cosmetics companies will face changes as well. Here are some of the potential effects for companies manufacturing these products:

1) Increased costs

The MoCRA will require cosmetic companies to conduct safety testing on all ingredients used in their products, which can be costly. Additionally, the requirement to follow GMPs will mean that companies will have to invest in quality control measures, documentation, and training. This will increase the cost of production, which could be passed on to the consumer.

2) Slower product launches

The requirement to submit safety data for all ingredients used in cosmetic products will mean that it may take longer for new products to be launched. Companies will have to conduct safety testing, compile data, and submit it for review, which could slow down the product development process.

3) Increased competition

The MoCRA will level the playing field for smaller cosmetic companies that may not have the resources to conduct safety testing or implement GMPs. This could lead to increased competition and market saturation.

4) Increased consumer confidence

Lastly, on the positive side of things, these new regulations will enhance the safety and efficacy of cosmetic products, which will increase consumer confidence in the industry. This could lead to increased sales for companies that comply with the new regulations.

The MoCRA is an important step toward enhancing the regulation of the cosmetic industry. It will increase safety, improve quality, and boost consumer confidence. However, it will also bring significant changes to how companies in the cosmetics industry perform business. Both cosmetics manufacturers and raw materials suppliers must be prepared to meet the new ingredient testing and labeling requirements, report adverse events, and comply with the increased FDA regulatory authority

If your company is going to be affected by MoCRA, consider using a document management system (DMS) to ease the burden of these regulatory changes. With a document management system like ENSUR, you’re provided with centralized data storage, version control, collaborative authoring, audit trails, and powerful search capabilities to make meeting compliance simple. Contact our sales team today to learn more about how ENSUR can help overcome the impending challenges posed by MoCRA. 

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Amy Sinyei Rodrigues is DocXellent's Chief Customer Officer. In this role, Amy works with our customers to make sure they are getting the most they can out of our Document and Specification Management Software, ENSUR. After graduating with a BS in Industrial Engineering and an MBA in General Management, Amy worked with several enterprise software and solution services providers in the electronic discovery industry before bringing her years of expertise and valuable education to DocXellent 6 years ago. Learn more about Amy and the work she does for DocXellent here.

Tags: cosmetics, 2023 regulations, MoCRA