Skincare brands face new compliance challenges with the Modernization of Cosmetics Regulation Act (MoCRA) 2022. MoCRA has introduced more stringent FDA requirements, which impact everything from ingredient safety to labeling. It is urgent for private labeling skincare companies to understand and adapt to these changes.
Since MoCRA is a core law in the cosmetics industry, expert guidance is paramount for navigating these strict regulations. By grasping the core requirements of MoCRA, you can safeguard your brand and ensure ongoing compliance.
Private labeling skincare manufacturers like Medpak Solutions help cosmetic brands tackle the new compliance challenges brought by the Modernization of Cosmetics Regulation Act (MoCRA) 2022. MOCRA imposes more stringent FDA requirements that affect ingredient safety, labeling, and more.
Our cosmetics manufacturing team will help you navigate these rules to stay compliant and protected under MoCRA’s core requirements.
A Manufacturing Execution System oversees and tracks work-in-progress on a production floor. It links real-time information with manufacturing processes to guarantee that operations meet quality benchmarks.
In a cosmetic production environment, for example, an MES monitors the entire lifecycle of a batch of cosmetic cream. It logs each stage, from blending ingredients to filling containers. Cosmetic producers ensure that each step complies with quality standards and regulatory guidelines.
Skincare Manufacturer and MES: A Symbiotic Relationship: Key Components
The MoCRA 2022, signed into law on December 29, 2022, is the first substantive rewrite of U.S. cosmetic law since the passage of the FDCA (Federal Food, Drug, and Cosmetic Act) in 1938. This reformist law increases the scope of FDA regulatory authority and enforcement powers over cosmetics.
MoCRA provides the FDA with a strong statutory scheme regulating cosmetics, with new powers for the FDA and higher standards. The most significant changes include the following:
With MoCRA’s updates, cosmetic products, including organic skincare products, must undergo a well-deserved safety approach and high standards. This is truly a major turn of events regarding how the U.S. regulates cosmetics.
December 29, 2024 | – GMP Rulemaking Proposed: New rules for Good Manufacturing Practices are under consideration. – Labeling Requirements: All items must include |
February 2025 | Allergen Labeling Regulation: New rules for allergen labeling have been established. |
December 29, 2025 | – FAS Report Published: The FDA report on PFAS is now available on their website. – GMP Regulation Finalized: The rules for Good Manufacturing Practices have been completed. |
Private-label skincare products or brands must register their facilities with the FDA and renew this registration every two years.
Proper support helps ensure your facility complies with registration requirements and effectively manages potential risks. This will avoid costly suspensions and disruptions to your business.
Skincare brands must ensure their products are safe. While the law and FDA regulations do not mandate specific tests for demonstrating product safety, a Responsible Person must maintain thorough records to substantiate the safety of the products.
Getting expert support can help manage these requirements effectively and ensure compliance.
Under the new Act, labeling requirements include:
Every brand ensures all labeling changes are implemented properly and on time to avoid compliance issues and potential penalties.
The Responsible Person must keep an updated annual list of marketed MoCRA cosmetics with the FDA. Initial listings are due by July 2024, and any new products must be listed within 120 days of their market introduction.
Having dedicated support helps ensure accurate and timely listings to maintain your compliance and simplify the reporting process.
Adapting to the Modernization of Cosmetics Regulation Act requires a solid understanding of new requirements. Every brand should maintain accurate product listings, meet new labeling rules, and ensure facility compliance. Having reliable guidance can help you adapt to these regulations smoothly and avoid compliance issues.
Medpak Solutions offers MoCRA Support to assist with all aspects of the new regulations, from safety substantiation and labeling to registration and product listing. We will make sure your products meet all regulatory requirements. Contact us today for more information on how we can help your brand stay compliant.
Your Most Frequently Asked Questions About Cosmetic Research & Trends in Skincare
The new regulations exempt certain small businesses from Good Manufacturing Practices (GMP), registration, and product listing requirements. However, this does not apply to manufacturers of products that contact the eye’s mucus membrane, are injected, intended for internal use, or are designed to alter appearance for more than 24 hours without easy removal by the consumer. Some products and facilities regulated as drugs or medical devices also have specific requirements.
Under MoCRA, a responsible person must report serious adverse events related to cosmetic products in the U.S. to the FDA within 15 business days. The report must include a copy of the product label. If additional medical information about the adverse event is received within one year, it must be reported within 15 business days. During inspections, the administration can access these adverse event reports.
If you are a manufacturer or processor of a cosmetic product, follow these steps:
