The Modernisation of Cosmetics Regulation Act (MoCRA) Guide

On December 29, 2022, President Joe Biden signed into law the Modernization of Cosmetics Regulation Act 2022 (MoCRA), marking a significant overhaul in U.S. cosmetics regulation not seen since the passing of the Federal Food, Drug, and Cosmetic Act in 1938. This transformative act, set to take effect on December 29, 2023, with some labeling requirements delayed until December 29, 2024, brings forth a redefinition of regulatory roles and a suite of new compliance requirements. Under MoCRA, the concept of a 'Facility' encompasses any establishment, whether within the U.S. or abroad, that engages in the manufacturing or processing of cosmetic products for the U.S. market. This definition specifically excludes entities such as beauty salons, pharmacies, and research laboratories. Additionally, MoCRA introduces the role of the 'Responsible Person', identifying them as the manufacturer, packer, or distributor whose name is on the cosmetic product's label, regardless of their geographic location.

A central feature of MoCRA is the requirement for Facility Registration. Facilities, including those based outside the U.S., are mandated to register with the FDA, the latter needing a U.S. agent for the process. This registration is not a one-time requirement but needs bi-annual renewal, starting from December 29, 2023. Alongside this, the Act requires the Responsible Person to list every cosmetic product sold in the U.S. on the FDA Cosmetics Direct portal. For new products, this listing should occur within 120 days of entering the U.S. market. MoCRA also touches upon Cosmetic Labeling & Fragrance Allergens. While it retains most of the current labeling rules, it introduces new requirements for products used professionally and those containing fragrance allergens, with a compliance deadline of December 29, 2024. Another critical aspect is Safety Substantiation. Responsible Persons are obligated to provide proof of product safety, adhering to a compliance deadline of December 29, 2023. The Act stipulates detailed procedures for Adverse Events Reporting, including the mandatory reporting of serious adverse events within 15 business days. In the realm of manufacturing, Good Manufacturing Practice (GMP) standards are set to be enforced, with the FDA expected to release the final regulations by December 29, 2025. Furthermore, MoCRA empowers the FDA with enhanced authority to suspend facility registrations, access records, and issue product recalls for safety reasons.

MoCRA also addresses specific concerns such as the Talc Rule and PFAS Report. It mandates standardized testing methods for detecting asbestos in talc-containing cosmetics and assessments of per- and polyfluoroalkyl substances (PFAS) in cosmetics, with final regulations and reports due in 2024 and 2025, respectively. Lastly, the Act provides a Small Business Exemption for businesses with annual sales under $1 million. While exempt from certain stipulations, these businesses must still adhere to labeling, safety substantiation, and adverse event reporting standards. In essence, MoCRA represents a comprehensive and modernized update to U.S. cosmetic regulations, significantly emphasizing product safety, transparency, and industry-standard compliance.

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Contrary to belief, cosmetic labels need not display a U.S. address for the Responsible Person by December 29, 2023. The Responsible Person, defined as the manufacturer, packer, or distributor on the label, doesn't need to be U.S.-based. Small businesses, while exempt from some MoCRA provisions, still have obligations like compliant labeling and safety substantiation. The UK & EU Cosmetic Product Safety Report (CPSR) doesn't automatically satisfy MoCRA's safety requirements, though similar standards are likely sufficient. All cosmetic products must be listed on FDA Cosmetics Direct by December 29, 2023, with new products allowed 120 days post-launch. Facilities must obtain an FEI number before registering on FDA Cosmetics Direct, and non-U.S. facilities require a U.S. agent for registration.

Fragrance allergens don't need to be listed on U.S. cosmetic products until December 2024, following an FDA notice in June 2024. Registrations from the Voluntary Cosmetic Registration Program (VCRP) won't automatically transfer to FDA Cosmetics Direct, necessitating re-listing by December 29, 2023. Full formulas, including quantities, aren't required for product listings, contrary to UK and EU regulations. Public access to information submitted on FDA Cosmetics Direct is yet to be clarified.

MoCRA doesn't mandate a medical doctor for handling adverse event reporting; this is the responsibility of the Responsible Person. Combination over-the-counter (OTC) drug/cosmetic products are not subject to product listing and facility registration under MoCRA, unless they also manufacture non-drug cosmetics. This clarification simplifies compliance for manufacturers of products like SPF cosmetics.

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The Modernisation of Cosmetics Regulation Act 2022 (MoCRA) defines a 'facility' as any establishment, including importers, that manufactures or processes cosmetics distributed in the U.S. To qualify as a 'facility,' the establishment must engage in manufacturing or processing, which includes making cosmetic products through various procedures and manipulating or testing the bulk formulation. Establishments involved only in activities like labeling, re-labeling, packing without touching the bulk formulation, repackaging, holding, or distributing are not considered 'facilities' under MoCRA. Also, certain places and entities are exempt from MoCRA's requirements, such as beauty shops, cosmetic retailers, healthcare clinics, public health agencies, entities providing complimentary cosmetics (like hotels or airlines), and establishments focusing solely on research or producing drug/OTC products.

Non-U.S. based facilities that meet MoCRA's definition are classified as 'foreign facilities' and must register with the FDA. They are required to collaborate with a U.S. agent for registration and are subject to FDA inspections and enforcement actions. To prepare for registration on the FDA Cosmetics Direct platform, a facility needs an FDA Establishment Identifier (FEI) number, obtainable from the FDA if not already held. When the FDA Cosmetics Direct portal becomes available, facilities must include in their registration the facility name, physical address, email, phone number, all brand names manufactured or processed, product categories, and the responsible person for each product. Facilities should gather this information in advance to streamline the registration process. Once registered, facilities are required to renew their registration every two years.

By clearly defining the scope of 'facility' and outlining the registration process, MoCRA aims to regulate the manufacture and processing of cosmetic products in the U.S. effectively, ensuring compliance and safety standards in the industry.

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The Responsible Person as defined in MoCRA is ‘the manufacturer, packer or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of MoCRA or section 4(a) of the Fair Packaging and Labelling Act.’Under this definition, the US Responsible Person (RP) can be one of the following three entities in the supply chain; the manufacturer, the packer or the distributor. If one of these is listed on the product packaging, they will be viewed as the US RP by the FDA under MoCRA.Looking into each of these roles within the industry the manufacturer would be the establishment or entity which produces the formulation, the packer would be the entity which packs the formulation and the distributor would be the entity who is selling the product. The distributor is usually the brand name and is the most likely out of the three roles to appear on the label.

Once the US RP has been correctly identified, it is important to also understand the framework around the role of RP and what is involved when an entity is the RP under MoCRA. Full legal compliance and liability for the cosmetic product remains with the US RP - it is their responsibility to ensure full compliance with MoCRA. Unlike the UK &EU where the RP role can be legally designated to a 3rd party via a mandate, there is no provision for this within MoCRA, the US RP role must be held by the manufacturer, packer or distributor. Consultancies and agencies can help the US RP understand and meet their obligations under MoCRA but the ultimate responsibility remains with the US RP.The US RP does not need to be located within the US. There is currently no provision within MoCRA which states this. However, there are certain requirements and contact information which must appear on the label to be compliant. The label should display the name of the RP alongside a domestic address (if they are US based) or a domestic telephone number (if they are US based) or electronic contact information such as an email address or website address. The purpose of this is to ensure that consumers areable to reach and report any adverse and serious adverse events.

Looking at the most common example of the US RP being the brand owner as they are the distributor named on the cosmetic product packaging, there is no requirement to update product labels before the 29th December 2023 with a US domestic address and/or telephone number. If the brand name, which is also the US RP under the MoCRA definition, is based outside of the US and they already have a website address on the label, this will be viewed as compliant under MoCRA based on the information the FDA have provided industry with so far. A product label would not be compliant if the label only displayed the brand name and non-US based address as there is no easy way for a US consumer to be able to contact the brand directly with any adverse or serious adverse event information.

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Section 605 of the Modernisation of Cosmetics Regulation Act 2022 (MoCRA) outlines the management of adverse and serious adverse events related to cosmetic products in the U.S., defining responsibilities for the U.S. Responsible Person (RP). An adverse event is any negative health-related event associated with cosmetic use, while a serious adverse event includes more severe outcomes like death, life-threatening experiences, hospitalization, disability, birth defects, infections, or significant disfigurement.

Consumers report adverse events through the product label, which must include contact information for the U.S. RP. The U.S. RP is responsible for a system to receive and process these reports. Only serious adverse events, as determined by the U.S. RP, must be reported to the FDA within 15 business days using Form 3500A, along with the product label. These reports must pertain to events occurring in the U.S. The U.S. RP also has to maintain an internal process for FDA communications and managing FDA inspections. New information related to a reported serious adverse event must be submitted to the FDA within 15 business days of its receipt. If a serious adverse event is linked to a fragrance or flavor ingredient, the U.S. RP must provide the FDA with the ingredient list or categories within 30 days. Records of all adverse events must be kept for six years, or three years for small businesses, and be available for FDA inspection. Compliance with Section 605 is mandatory by December 29, 2023.

Section 608 of MoCRA focuses on safety substantiation, requiring the Responsible Person to ensure and maintain records proving a cosmetic product's safety. This involves tests, studies, research, or other evidence evaluated by qualified experts. Safety is defined as not causing harm under prescribed or customary usage conditions, even if minor skin reactions occur without needing medical intervention. The industry believes that a UK/EU Cosmetic Product Safety Report, preservative efficacy testing, and human repeat insult patch testing (HRIPT) may suffice for safety substantiation. Compliance with Section 608 is also required by December 29, 2023.

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In the United States, cosmetic products must comply with three main regulations: the Food, Drug & Cosmetic Act of 1938 (FD&C Act), the Fair Packaging & Labeling Act, and the Modernization of Cosmetics Regulation Act (MoCRA). The FD&C Act safeguards consumers against unsafe or misleadingly labeled products, while the Fair Packaging & Labeling Act ensures accurate information about product contents. MoCRA, the most recent addition, introduces new labeling requirements for cosmetics, including mandatory inclusion on product labels.

A key aspect of cosmetic labeling is the Principal Display Panel (PDP), typically the front label of the product's secondary or outer carton, visible during retail display. Rules for PDPs do not apply to products with only primary or inner labeling. Labeling requirements, including font size and net quantity location, are determined by the PDP's surface area. Other label sections are considered 'information panels', providing additional required details. For smaller packages, such as compacts or products with less than 1/4oz, the PDP can be a tag, tape, or display card attached to the container. The label must clearly differentiate between secondary/outer and primary/inner labeling requirements.

Each cosmetic product must include specific labeling elements: product identity, net quantity of contents, directions for safe use, warnings, name and place of business of the manufacturer, packer, or distributor, and ingredients list. Certain products require specific warnings (e.g., cosmetic aerosols, feminine deodorants, foaming detergent bath products). Additionally, MoCRA introduces requirements for indicating the US Responsible Person on labels and mandates the listing of ingredients, including EU fragrance allergens. Other necessary label elements include the country of origin, batch code, expiry date, and professional use statement. Product claims must be truthful, non-misleading, and substantiated, avoiding any medicinal claims. Digital labeling, such as QR codes, can supplement but not replace physical label information. Compliance with these regulations is crucial for the lawful sale of cosmetic products in the US.

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Section 612 of the Modernisation of Cosmetics Regulation Act (MoCRA) provides a specific exemption for small businesses in the cosmetics industry. To qualify as a small business under this section, a company must have average gross annual sales in the United States of less than $1 million, adjusted for inflation, over the previous three years. Additionally, these entities should not be involved in the manufacturing or processing of certain cosmetic products outlined in subsection (b). Qualifying small businesses are exempt from the Good Manufacturing Practice (GMP) requirements specified in Section 606 of MoCRA. They are also relieved from facility registration and product listing mandates set forth in Section 607. Furthermore, Section 605 stipulates a reduction in the duration for keeping adverse event records for small businesses, shortening the requirement from six years to three years.

However, it's important to note the limitations of this exemption. Small businesses engaged in producing certain types of cosmetic products, such as those regularly in contact with the eye's mucous membrane, injectables, products intended for internal use, or products that change appearance for over 24 hours and are not typically removed by consumers, do not qualify for the exemption. These products are usually not considered cosmetics under the FDA's definition. When a business's sales exceed the $1 million threshold within the United States over a three-year period, it must fully comply with MoCRA and will no longer be eligible for the small business exemption. Small businesses are advised to adhere to all provisions of MoCRA as early as possible. While there are no penalties for early compliance, there are penalties and potential FDA enforcement actions for businesses that fail to comply with Sections 605, 606, and 607 when required.

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Curious about submitting a product listing via FDA Cosmetics Direct? We've got you covered! 🌐 We have created an easy to use tracker to ensure you are capturing accurate information on the products which need to be listed on FDA Cosmetics Direct.The first tab is an overview of your US cosmetic product portfolio and should include top level information about the product, US RP and manufacturing facilities.The second tab should be populated to include the detailed information regarding the cosmetic products listed on the first tab. This is the tab to use when completing your listing on FDA Cosmetic Direct and tracking of the submission to approval.

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Are you prepared for Cosmetic Facility Registration under MoCRA? Let's make sure you are! Under MoCRA, a 'facility' is any establishment (including importers) manufacturing or processing cosmetic products distributed in the U.S. The Act specifies that the 'manufacture of a cosmetic product' involves procedures applied to the bulk formulation. This includes production and manipulation, like filling processes. An establishment is not considered a 'facility' if involved in labelling, re-labelling, packing (without touching the bulk formulation), repackaging (without touching the bulk formulation), holding, or distributing. If an establishment qualifies as a 'facility' under MoCRA, it must complete registration on the FDA Cosmetics Direct platform. MoCRA exempts certain places and establishments, including beauty shops, cosmetic retailers, healthcare facilities, non-profit entities, and those providing complimentary cosmetics. Also excluded are facilities producing cosmetics solely for research or evaluation.Non-U.S. facilities meeting the 'facility' definition must register with the FDA as 'foreign facilities.' Collaboration with a domestic U.S. agent is required, and these facilities are subject to FDA inspections and enforcement actions.

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