New requirements for cosmetic product manufacturers under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) are being phased in throughout 2024, affecting cosmetics products and facilities. That means cosmetics manufacturers must analyze their quality systems to identify gaps and ensure they are ready to implement any necessary changes to comply with the new law. And for companies that don’t yet have a robust quality system, now is the time to establish one.
In December 2022, the signing of the Modernization of Cosmetics Regulation Act (MoCRA) marked the most significant expansion of the FDA’s authority to regulate cosmetics in nearly 85 years. That law, which imposes new facility registration, adverse event reporting, and GMP requirements, takes effect this year. Vital new requirements in the law include facility registration, product listing, adverse event reporting and record-keeping, safety substantiation, recall authority, and records access. The requirements apply to cosmetics manufacturers, packers, and distributors.
Particularly significant is MoCRA’s instruction that the FDA issue regulations establishing GMP requirements for cosmetic-manufacturing facilities, along with fragrance allergen labeling requirements and standardized testing methods for detecting and identifying asbestos in talc-containing products.
Although these requirements are new to cosmetics, the GMP concepts underlying them are not. They mirror requirements that have been in place for pharmaceutical and medical device companies for years. And they all fall under the umbrella of quality management.
Savvy cosmetics companies should already have a quality management system that includes all the necessary organizational structure, responsibilities, resources, procedures, processes, and information systems to maximize product quality, as Compliance Architects described in a 2016 white paper, Quality System Design for Cosmetics Products Manufacturing.
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Understanding Modernization of Cosmetics Regulation Act of 2022 and its history
In essence, MoCRA aims to update cosmetic regulations to better align with rules governing other industries that the FDA oversees. The FDA gained authority over cosmetics with the initial FD&C Act, passed in 1938. However, this authority did not include any pre-sale review or mandatory safety testing, nor did the FDA have the authority to recall cosmetics. Over time, the agency developed a voluntary cosmetic registration program but lacked enforcement authority in other areas.
Nonetheless, FDA enforcement activity related to cosmetics has been on the upswing for the past decade, particularly as regards the potential adverse health consequences of death related to imported products and ingredients.
The agency issued draft guidance, Cosmetic Good Manufacturing Practices, in June 2013. The recommendations in that draft apply to any cosmetics product manufactured or processed for sale in the US, so manufacturers, packagers, and distributors can all apply its recommendations. Although, as a guide, the document’s recommendations were not mandatory, they do reflect the agency’s growing interest in cosmetics quality and safety, and savvy cosmetics firms have already incorporated its suggestions into their internal processes.
The Cosmetics Architects white paper referenced above bases its advice on the recommendations in that document.
Modernization of Cosmetics Regulation Act of 2022 is also meant to boost the FDA’s authority over cosmetics, focusing on managing potential health risks that cosmetic products might pose to consumers. For instance, the adverse event reporting requirement is supposed to address the historic under-reporting of adverse events associated with cosmetics. The primary changes under the new law are:
- Facility registration: Cosmetic manufacturers and processors must register their facilities with the FDA. Registration is for two years, and the agency has the authority to suspend a facility’s enrollment in the face of severe violations regarding products made there.
- Product listing: Companies must list each marketed cosmetic product with the FDA, including ingredients. Product listings must be updated annually.
- Adverse event reporting and record-keeping: Cosmetics manufacturers must report serious adverse events associated with a cosmetic product to the FDA within 15 business days.
- Safety substantiation: Cosmetic companies must ensure the safety of their products. Neither the law nor FDA regulations require specific tests to demonstrate the protection of individual products or ingredients. However, companies are expected to have their procedures in place and to maintain records supporting and documenting the safety substantiation of their products. Data used to support cosmetic safety must be based on scientifically robust methods.
- Recall authority: MoCRA gives the FDA the power to order a mandatory recall in the face of evidence that a cosmetic is adulterated, misbranded, or poses a health risk to consumers if a manufacturer refuses to institute a voluntary recall.
- Records access: The law also gives the FDA authority to access and copy certain documents related to cosmetic products, including safety records.
All these changes aim to strengthen the FDA’s oversight of cosmetic products to align more closely with that applied to other products—like pharmaceuticals and medical devices—over which the agency has authority.
Prepare the system now; fill in details as the FDA shares information.
While Modernization of Cosmetics Regulation Act of 2022 does mark a sea change in the modernization of cosmetics regulation, firms that have applied the 2013 guidance likely already have a leg up on complying with all the existing and developing requirements under the new law. The basics of establishing a quality system remain the same, and it’s unlikely that new GMP regulations would stray too far from the recommendations in the guidance.
Firms must remember that, in addition to ensuring regulatory compliance, a properly designed quality system can provide significant risk-avoidance benefits, such as ensuring that products reliably meet consumer expectations and pose no health risks. In the face of the FDA’s focus on offshore supply chains in recent years across all the industries it oversees, a solid quality system can reduce the risk of import holds on ingredients or finished products.
In the future, under Modernization of Cosmetics Regulation Act of 2022, cosmetic firms should plan immediately for registration and product listing requirements, which the agency has already described. Reviewing the law’s requirements for product safety substantiation, record-keeping, and adverse event reporting can also provide clues as to specific additions to their quality systems.
Cosmetic companies should stay alert for FDA discussions around the upcoming GMP rulemaking. Community meetings and comment periods can allow firms to weigh in with concerns and understand where the agency will go with the new regulations. They should also be alert to guidelines the agency will likely issue in the coming year.
Compliance Architects can provide support.
Taking the time now to review products, policies, and procedures and evaluate existing quality systems will help cosmetic manufacturers stay ahead of the curve as regulatory requirements evolve in the coming months. Early preparation will allow companies to be agile in responding to requirements changes.
But companies don’t have to do it alone to create or enhance quality systems that easily incorporate new developments under Modernization of Cosmetics Regulation Act of 2022. Compliance Architects provides specialized services and expertise in navigating the evolving regulatory landscape of the cosmetic industry. From ensuring compliance with evolving MoCRA requirements to addressing industry-specific needs, our team offers decades of experience with GMPs and the cosmetic industry and the know-how to develop individually tailored solutions to help each firm navigate the upcoming regulatory changes.
Visit our page dedicated to the cosmetic industry, or contact us below to learn more about how we can assist in compliance and regulatory matters.