In the United States, the Modernisation of Cosmetics Regulation Act of 2022 (MoCRA) was passed by Congress in 2022 and was 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 the FFDCA, the FDA has broad authority to, among others, ban or restrict cosmetic ingredients for safety reasons (including adulteration and mis-branding), mandate cosmetic warning labels, inspect manufacturing facilities, seize illegal products, and work with companies to implement product recalls.
The FFDCA’s effectiveness was limited. 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 FDA’s authority over cosmetics was less comprehensive than other regulated products, such as regulatory expectations already in place for food, drugs, and medical devices, 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 safety of their products and ingredients before marketing.
Under MoCRA, the FFDCA requirements still exist. MoCRA is considered an expansion of the FDA’s authority to regulate cosmetics and personal care products.
The key improvements under MoCRA are as follows:
Responsible Person
The “responsible person” is the individual or entity designated to ensure a cosmetic product is compliant with FDA requirements. Usually, this is either the manufacturer, packer, or distributor whose name appears on the product label. They also act as the FDA’s main point of contact regarding the product. The name and address of the Responsible Person must be present on the packaging from 29th December 2024.
Facility Registration
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.
Product Listing
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.
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.
Adverse Event Reporting
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 such an outcome as described above.
FDA Enforcement Powers Expanded
MoCRA gives the FDA expanded enforcement powers, including the authority to access company records, suspend facility registrations, and mandate product recalls if there is a reasonable probability of serious health consequences.
Asbestos in talc
On 26 December 2024, a rule was proposed to establish standardised testing methods for detecting and identifying asbestos in talc-containing cosmetic products.
This proposed rule requires manufacturers of talc-containing cosmetic products to test for asbestos using an analytical approach that includes both Polarized Light Microscopy (PLM) (with dispersion staining) and Transmission Electron Microscopy (TEM)/Energy Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED) to detect and identify the presence of asbestos. Or, alternatively, manufacturers may rely on a certificate of analysis from the talc supplier. The proposed rule contains provisions that would require manufacturers to keep records to demonstrate compliance with the rule.
The comment period for this proposed rule ended at the end of March 2025 and then the FDA will review and consider comments as it develops the final rule.
If the proposed rule is finalised, cosmetic products would be considered adulterated under the FDCA if:
- asbestos is present in a cosmetic product
- asbestos is present in talc used in a cosmetic product,
- a manufacturer fails to comply with either testing or recordkeeping.
Good Manufacturing Practices (GMPs):
The FDA was directed to establish mandatory GMP regulations for cosmetics.
GMP regulations already exist for, and are strictly enforced for drugs, medical devices, dietary supplements, and food. Cosmetics were the major outlier, and MoCRA was specifically designated to close that gap.
The GMP proposal was due by December 2024 and the regulation should have been finalised by December 2025. Once finalised, cosmetic manufacturers must comply with these GMP standards to ensure products are consistently produced and controlled to meet quality and safety standards.
The FDA has signalled in public meetings and updates that they are actively working on the proposed cosmetic GMP rules, referencing existing GMP practices such as ISO 22716 as possible frameworks.
As of April 2025, the FDA has not yet issued the proposed rule for GMP. The anticipated date for the Notice of Proposed Rulemaking (NPRM) has been delayed to October 2025. This means that the final GMP rule is unlikely to be issued before late 2026.
Fragrance allergens
The fragrance allergens that are required to be listed on the label were to be determined and published by FDA by June 2024. The revised deadline of January 2025 has also been missed and an update is due.
PFAS in cosmetic products
A report on the use of PFAS in cosmetic products and their safety is due. The FDA are to assess the use of PFAS in cosmetic products and the scientific evidence surrounding their safety.
Overall, MoCRA will bring the cosmetics industry closer in line with the regulatory expectations already in place for food, drugs, and medical devices, aiming to boost consumer safety, industry transparency, and FDA oversight.
MoCRA does have a clause that prohibits US states from establishing requirements that differ from this federal framework. However, states can ban and restrict the use of substances in cosmetic products within their national systems. Several states, including California, New Hampshire and Washington, have restricted the use of cosmetic substances since MoCRA took effect but they cannot have less or ignore the provisions of MoCRA.
Published August 20th, 2025
This article was generated with the assistance of Artificial Intelligence.