As a cosmetics manufacturer, you more than others, understand the integral role your products play in your customers’ everyday lives.
In the US, each person uses between 6 to 12 different cosmetic products daily, ranging from makeup and nail polish to shaving cream, perfume, and a wide variety of skincare products.
Given their widespread use, safety and regulation are critical, and in light of this, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has been created.
This act is the most substantial expansion of FDA’s authority to regulate cosmetics since the passing of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938.
For small cosmetics manufacturers, compliance with this new legislation is essential. But what does compliance entail? In this article, we’ll break down the key points of MoCRA that you need to know:
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Adverse Event Reporting
If your product causes a serious adverse health event, it must be reported to the FDA within 15 business days. Whenever there’s additional information about the adverse event, that information should also be submitted to the FDA within 15 business days of receipt.
Facility Registration
Every facility that manufactures or processes cosmetic products for the U.S market must register with FDA and renew this registration every two years. If a product made or processed at your facility is found to pose a serious health risk, the FDA can suspend your registration.
Product Listing
Every cosmetic product on the market must be listed with the FDA. This listing should include the ingredients of the product and must be updated annually.
Safety Substantiation
As a manufacturer, you are required to ensure the safety of your products and maintain records that substantiate this safety. While the law does not specify what tests should be used to prove safety, it’s important that all supporting data are derived from scientifically robust methods.
Good Manufacturing Practice (GMP) Requirements
The FDA will establish GMP requirements for facilities that manufacture cosmetic products. These regulations will need to be adhered to for compliance with MoCRA.
Read more: GMP for Small Manufacturers - A Simple Guide
Labeling Requirements
The information listed on your cosmetic product’s label must be accurate and adhere to the FDA’s labeling regulations. This includes listing all ingredients in descending order of concentration, proper usage instructions, and any necessary warnings or precautions.
Cosmetic Ingredient Review (CIR) Program
This program aims to review the safety of cosmetic ingredients and publishes regular reports on its findings. As a small cosmetics manufacturer, it’s essential to stay updated with the latest CIR publications to ensure your products’ compliance.
Product Recalls
In case of a safety issue or violation of regulations, the FDA has the authority to recall cosmetic products from the market. It’s crucial for small manufacturers to have proper procedures in place for handling recalls and ensuring the safety of their customers.
Third-Party Certification
MoCRA allows for third-party certification as a means of demonstrating compliance with the new regulations. This can be beneficial for small cosmetics manufacturers who may not have the resources to conduct all necessary tests and evaluations themselves.
Exemptions
Certain small businesses are exempt from some of the requirements such as GMP, registration, and product listing. However, this does not apply if you manufacture or process specific types of cosmetics.
While MoCRA establishes comprehensive oversight for the cosmetics industry, there are exemptions designed to alleviate the burden on certain small businesses. Small business entities that have annual gross receipts of less than $1 million are often exempt from some of MoCRA’s requirements, such as registration, product listing, and Good Manufacturing Practices.
However, this exemption does not apply across the board. If your business manufactures or processes cosmetics that are deemed drugs under the FD&C Act, or if the products are intended for use in areas dispersed into the air, or used on animals, standard compliance measures must be followed regardless of business size. It is critical for small manufacturers to review their product lines and business models against the specific criteria set forth in MoCRA to determine their eligibility for these exemptions.
Seeking Further Assistance on MoCRA
For manufacturers seeking more information or clarification on the Modernization of Cosmetics Regulation Act of 2022, several resources are available. The Food and Drug Administration (FDA) is the primary regulatory body overseeing MoCRA and provides comprehensive guidance including FAQs, fact sheets, and direct support for queries. Cosmetics manufacturers can contact the FDA’s Office of Cosmetics and Colors at fda.gov/cosmetics for regulatory questions.
The Personal Care Products Council (PCPC) is the leading national trade association for the cosmetics and personal care products industry, the PCPC represents most of the largest, as well as many small to mid-sized companies that manufacture or distribute personal hygiene and cosmetic products. Their aim is to advocate for the industry and provide expertise on scientific, legal, regulatory, legislative, and international issues. Members companies of PCPC are granted access to a wealth of resources and guidance, particularly useful in navigating the complexities of compliance with regulations such as MoCRA.
For tailored legal advice, consider consulting with an attorney or law firm specializing in FDA regulations and cosmetics compliance. It is advisable to proactively reach out to these resources to ensure a smooth transition to full MoCRA compliance.
Benefits of Inventory Software for MoCRA Compliance
Utilizing specialized inventory software can be a game-changer for small cosmetics manufacturers aiming for MoCRA compliance.
Such software can automate and simplify the tracking of product batches, ingredient sourcing, and manufacturing dates essential for adverse event reporting and recalls. It offers a streamlined approach to manage and update product listings, an invaluable tool to ensure compliance with the constantly evolving FDA requirements. Moreover, inventory management systems are crucial for maintaining records crucial for safety substantiation and providing evidence of adherence to GMP requirements.
Meet Craftybase, a tailor-made inventory solution designed with the unique needs of small cosmetics manufacturers in mind. This software can help simplify the intricate details of MoCRA compliance by organizing your product information in one accessible location. From managing raw materials to tracking finished products, Craftybase provides a clear audit trail that can be indispensable during regulatory reviews or inspections.
Interested in seeing how Craftybase can transform your business compliance practices? Start with a free trial today and take the first step towards effortless inventory management and regulatory adherence. Sign up for a free trial and discover the ease of aligning with MoCRA standards using Craftybase.
Conclusion
Compliance with MoCRA is not just about meeting regulatory requirements.
It is about ensuring the safety and satisfaction of your consumers, which ultimately leads to the success of your brand.
For additional information on registration, product listing, product testing, and other related topics, refer to the appropriate sections on the FDA’s website. Stay compliant, and stay successful!
