In the United States the Modernisation of Cosmetics Regulation Act of 2022 (MoCRA) was passed by Congress in 2022 and is the first major update concerning the regulation of cosmetics since the passing of FFDCA (Federal Food Drug and Cosmetic Act) in 1938. The FFDCA Act gave authority to the FDA (Food and Drug Administration) to ensure that cosmetics are safe and properly labelled. Under this remit, the FDA has broad authority to ban or restrict cosmetic ingredients for safety ingredients, mandate cosmetic warning labels, inspect manufacturing facilities, seize illegal products, prohibit and stop unlawful activities and prosecute violators and work with companies to implement product recalls.Under MoCRA, these FFDCA requirements still exist. MoCRA is considered an expansion of the FDA’s authority to regulate cosmetics and personal care products.
The limitations of the FFDCA were widely recognised. The registration of manufacturing facilities, the reporting of ingredients used in cosmetic products and the reporting of adverse reaction to cosmetics were voluntary components of this act. In addition, the FDAs authority over cosmetics was less comprehensive than other regulated products with regards to Good Manufacturing Practice (GMP), pre-market approval, testing and mandatory risk labelling. The only ingredients reviewed or approved by the FDA are colour additives, even though cosmetic manufacturers are responsible for substantiating the safely of their products and ingredients before marketing.
Under MoCRA, each cosmetic product placed on the market in the US must have a designated Responsible Person. This can be the manufacturer, packager or distributor and their name and address must be present on the packaging by 29th December 2024.
MoCRA gives new authority to the FDA to:
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Access records
Provided certain conditions are met, the FDA can access and copy records relating to a cosmetic product. This will include safety records.
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Mandatory recall
If there is a reasonable probability that there is misbranding or adulteration of a cosmetic product, and that use of said cosmetic product will cause serious adverse health consequences or death, then the FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily.
The expanded Act (MoCRA) intends to start with the following specific additional requirements:
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Serious Adverse Effects
There are new updated instructions for reporting Serious Adverse Effects.
The responsible person should report serious adverse events associated with the use of a cosmetic product to the FDA within 15 business days. Further medical or other information received within one year of the initial report should also be submitted within 15 business days.
A serious adverse event is one that results in any of the following: death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability/incapacity, a congenital anomaly or birth defect, infection or significant disfigurement OR requires, based on reasonable medical judgement, a medical or surgical intervention to prevent an outcome described above
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Registration of manufacturing facilities/processors and contract manufacturers
Existing facilities and processors should have registered by 1 July 2024. New facilities are required to be registered within 60 days of beginning operations and all registrations are to be renewed biennially. Contract manufacturers are also required to register. The FDA will have the authority to suspend the registration of a facility if a cosmetic product manufactured or processed by the registered facility and distributed within the US has a “reasonable probability of causing serious adverse health consequences or death” and for which the FDA has “reasonable belief” that other products manufactured or processed at the facility may be similarly affected.
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Ingredient list submission
An ingredient list for all existing cosmetic products should have been submitted to the FDA by 1 July 2024 either by the manufacturers, the processors or the distributors. New products should have their ingredient list submitted within 120 days.
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Safety Substantiation
There is a responsibility on companies or individuals who manufacture or market cosmetics to ensure the safety of their products. No specific tests are required by either the law or the FDA to demonstrate the safety of individual products or ingredients.
The term ‘‘adequate substantiation of safety’’ means tests or studies, research, analyses, or other evidence or information that is considered sufficient to support a reasonable certainty that a cosmetic product is safe. Any ingredient used in the formulations of cosmetics is allowed, provided that the safety of the ingredient has been adequately substantiated. Traditional testing of cosmetic ingredients has used animal models to evaluate the safety of the ingredients. However, the FDA does not specifically require such testing and has outlined its support for non-animal testing.
Under MoCRA, there are also requirements for industry to comply with regulations listed below which are expected to be established in 2024 and beyond.
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GMP
The requirements for GMP are expected to be available for review sometime during 2024. However, the FDA have indicated that facilities that are already compliant with 2013 guidance and/or ISO 22716 certified should comply with no difficulty.
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Fragrance allergens
The fragrance allergens that are required to be listed on the label are to be determined and published by FDA by June 2024 (this is now delayed) and subsequently will have to be listed on the cosmetic product label.
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Asbestos in talc
A proposed rule for testing and identifying asbestos in talc should be available late 2024
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PFAS in cosmetic products
The FDA will assess the use of PFAS in cosmetic products and the scientific evidence surrounding their safety and publish a report summarizing their findings by December 2025.
Finally some States have additional requirements to those under FDA/MoCRA, such as California Safe Cosmetics Act but they cannot have less or ignore the provisions of MoCRA.
Published August 26, 2024
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