On December 29, 2022, U.S. President Joe Biden signed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) into law, amending Chapter VI: Cosmetics of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and introducing new provisions for cosmetic products. This marks the first substantial amendments to the U.S. Food and Drug Administration's (FDA) regulatory oversight for cosmetic products since 1938, bringing cosmetic regulations in the country up to date with modern needs.
The regulatory changes brought by MoCRA impact various stages of the cosmetic product’s lifecycle, resulting in heightened scrutiny and more stringent compliance obligations on cosmetic businesses. Most provisions take effect one year from enactment, or by December 29, 2023. During this time, cosmetics enterprises should familiarize themselves with the new legislation and its key deadlines, and promptly prepare to take appropriate measures to comply with the new regulatory requirements, thereby successfully handling the evolving landscape of cosmetic regulation in the United States.
Part 1 New Obligations for Cosmetics Enterprises
1. Cosmetic Product Definition
MoCRA primarily focuses on the regulation of cosmetic products, which are defined as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product”.
It does not cover over-the-counter (OTC) drugs that make cosmetic claims, such as anti-dandruff shampoo, moisturizers/makeup marketed with sun-protection claims, etc. Instead, OTC drug regulations apply to these products. Nevertheless, it is worth mentioning that certain provisions of MoCRA relating to fragrance allergen disclosure and professional use labeling remain applicable in these cases.
2. Facility Registration
Under MOCRA, any establishment that manufacturers or processes cosmetic products for the U.S. market, irrespective of their location (whether in the US or overseas), must register their facility (including contract manufacturers) with the FDA.
However, certain establishments engaged solely in specific activities, such as labeling, relabeling, packaging, repackaging, holding, and/or distributing of cosmetic products, are exempt from this registration requirement. It is noteworthy that facilities involved in "packaging" and "repackaging" by filling product containers with cosmetic products are still required to be registered. Additionally, various entities, including beauty shops, salons, cosmetic retailers, direct sellers, hospitals, pharmacies, physicians' offices, health care clinics, trade shows that provide product samples, and establishments manufacturing or processing cosmetics solely for research or evaluation purposes, are also excluded from mandatory facility registration.
The compliance requirements vary depending on the circumstance and type of facility, as shown in the table below.
Types of Facilities
Compliance Requirements for FDA Registration
Facilities in operation when MOCRA was enacted
Must complete registration with the FDA by December 29, 2023.
Must be registered within 60 days after they begin manufacturing or processing cosmetics, or within 60 days after December 29, 2023, whichever is later.
Facilities engaged in contract manufacturing
Only a single registration for the facility is required by the FDA. This registration application can be submitted either by the contract manufacturer itself (entrustee) or by the responsible person whose products are manufactured or processed at that facility (entruster).
The required registration information includes:
Facility’s name, physical address, email address, and telephone number (for foreign facilities: contact information of the U.S. agent, including electronic contact information);
Facility registration number, if previously assigned by FDA;
All brand names under which cosmetic products manufactured or processed in the facility are sold;
Product category or categories and responsible person for each cosmetic product manufactured or processed at the facility.
Notably, all facility registrations must be renewed biennially, and any changes to the registration information must be reported to the FDA within 60 days after the change happens. Foreign companies must appoint a U.S. agent during registration to serve as the communication link between the FDA and the overseas company.
3. Product Listing
MoCRA does not impose a pre-market approval requirement for cosmetics. Instead, it mandates that the responsible person for cosmetics intended for sale in the U.S., namely, manufacturer, packer or distributor of a cosmetic product whose name appears on the label, must list each marketed cosmetic product, including product ingredients, with the FDA.
The necessary information for product listing includes:
Facility registration number of each manufacturing or processing facility for the cosmetic product.
Name and contact number of the responsible person, as well as the product name as it appears on the label;
Applicable cosmetic category or categories for the product;
A list of ingredients in the cosmetic product, including any fragrances, flavors, or colors (excluding formulas or recipes). Each ingredient should be identified by the name required in the Code of Federal Regulations (21 CFR Part 701.30) or by its common or usual name;
Product listing number, if previously assigned by FDA.
Existing cosmetic products, which were already on the market prior to the enactment of MoCRA, must be listed with the FDA no later than December 29, 2023. For new products introduced to the market after MoCRA's enactment, listing with the FDA should be done within 120 days from the date of their initial marketing.
The responsible person for cosmetic products shall update their product listings annually. If no change has happened since the previous listing submission, the annual listing renewals can enjoy an abbreviated procedure. Moreover, cosmetics with identical formulations or minor variations in color, fragrance, flavor, or quantity of contents can be listed under a single listing.
Facility Registration vs. Product Listing
Each manufacturing and processing establishment involved in the production of cosmetic products
Each individual cosmetic product
Cosmetic manufacturer, including contract manufacturers
(* Foreign facilities must have a U.S. Agent for registration)
Cosmetic responsible person
(* The labeling requirements state that contact information on the label should be a U.S. contact while the responsible person definition doesn't require them to be within the territory of the U.S.)
Renewal and Updates
Details of the facility registration and product listing process under MoCRA have not been announced by FDA officials yet. However, it has been confirmed that a new registration and listing system will be established. The previous FDA Voluntary Cosmetic Registration Program (VCRP) was discontinued on March 27, 2023. Any information previously submitted through VCRP will not be transferred to the new system. Therefore, all registration and listing information will need to be resubmitted, even for those who participated in the VCRP before.
On August 7, 2023, the U.S. Food and Drug Administration released a draft guidance on cosmetic facility registration and product listing (draft guidance), seeking to refine the relevant statutory requirement for cosmetic facility registration and product listing. The draft clarifies the definitions of key terms such as “contract manufacturer”, “responsible person”, “facility”, “DUNS number”, etc., and offers comprehensive guidance on the entities responsible for submitting applications for registration and listing, the necessary dossiers, submission methods, submission deadlines, and exemptions from registration and listing requirements, etc.
Furthermore, the draft introduces some additional details, including the anticipated launch of a new electronic portal for registration and listing submissions in October 2023, as well as the adoption of the FDA Establishment Identifier (FEI) as the facility registration number.
For more in-depth information, please refer to our news on this topic.
4. Good Manufacturing Practices (GMPs)
Adherence to GMPs in the US cosmetics industry has historically been voluntary, albeit highly encouraged. However, with the implementation of MoCRA, there is a significant shift as GMP requirements will become mandatory for all cosmetic manufacturers.
FDA will formulate and enforce mandatory GMP regulations that align with national and international standards, such as ISO 22716. The formulation of these regulations will take into account the specific needs of smaller businesses by including simplified GMP requirements, as well as the economic impact on these businesses.
To facilitate this process, the FDA is expected to issue a proposed rule on the GMP regulations by December 29, 2024, followed by its finalization by December 29, 2025. It is important to note that from then on, any cosmetic product manufactured or processed without complying with these GMP conditions will be considered adulterated.
5. Cosmetics Safety Substantiation
Previously, cosmetic products were not subject to safety approval or certification prior to being marketed. However, under MoCRA, responsible persons are now entrusted with the duty to not only ensure the safety of their products and ingredients, but also to maintain records that demonstrate adequate substantiation of their safety.
The term “adequate substantiation of safety” encompasses tests, studies, research, analyses, and/or other evidence of information that is considered by experts who are qualified by scientific training and experience, as sufficient to support a reasonable certainty that the cosmetic product and its ingredients are “safe” (i.e., are not injurious when being used in accordance with the labeling or customary use). FDA has not published any guidance on how to substantiate whether a cosmetic product or its ingredients are safe. A cosmetic product may be deemed as adulterated if the requirement is not met.
6. Labeling Requirements
In addition to the existing cosmetic labeling regulatory requirements (21 CFR Part 701) and Cosmetic Labeling Guide established by the FDA, MoCRA now extends these requirements, requesting cosmetic responsible persons to provide additional labeling details.
Professional Use Cosmetics Labeling
Specifically, for cosmetic products intended for "professional use" by licensed professionals such as cosmetologists, nail technicians, barbers, and estheticians, there are specific labeling obligations in addition to those applicable to cosmetics intended for general consumer sale. These products must have a clear and prominent statement on the label, indicating that the product should only be administered or used by licensed professionals. This labeling change will come into effect on December 29, 2023.
U.S. Contact Information Identification for Adverse Event Reporting
Effective from December 29, 2024, all cosmetic products must bear a label that includes U.S. contact info, such as U.S. address, phone number, or electronic contact information like a website, whereby the responsible person can receive adverse event reports associated with the use of the product.
Fragrance Allergens Disclosure
Starting in early 2025, cosmetic labels will be required to disclose each fragrance allergen in the product, which is a significant change from the current practice of listing fragrance ingredients simply as "Fragrance" or "Flavor". The FDA will draft a proposed rule to identify a list of specific fragrance allergens by June 29, 2024, which will go through a 180-day comment period before being finalized.
Notably, failure to disclose the necessary fragrance allergens on product labels will result in the product being considered misbranded, which may lead to enforcement action by the FDA.
7. Post-Market Supervision: Adverse Event Reporting
Similar to other product categories regulated by the FDA, such as dietary supplements and Over-the-Counter (OTC) drugs, cosmetic responsible persons will be obligated to maintain records of "adverse events" and report “serious adverse events”.
Serious Adverse Event (SAE)
"Any health-related event associated with the use of a cosmetic product that is adverse."
An adverse event that results in, or requires medical intervention to prevent:
Adverse Event Recordkeeping
Cosmetic responsible persons will have to maintain the records of all health-related adverse events associated with the use of their products in the United States for six (6) years. For small business, the recordkeeping period will be three (3) years.
Serious Adverse Event (SAE) Reporting
Furthermore, cosmetic responsible persons must report any serious adverse events to the FDA within 15 days upon receipt of such issue, accompanied by a copy of the product label that is printed on or put within the retail packaging. In addition, for one year following the initial report, if any "new and material" medical information pertaining to the serious adverse event is received, the responsible person must submit this information to the FDA within 15 days of its receipt.
Significantly, the labeling of cosmetic products must clearly include a point of contact within the United States for the reporting of adverse events. In the event that the FDA has reasonable grounds to suspect that an ingredient or combination of ingredients in a fragrance or flavor has caused or contributed to a serious adverse event, and subsequently requests a list of such ingredients or categories of ingredients in the said fragrance or flavor, the responsible person must provide the requested information to the FDA within 30 days after such request. This information is exempt from Freedom of Information Act (FOIA) disclosure.
Small business convenience
Certain small businesses are eligible for exemptions from facility registration, product listing, and GMP requirements, provided that their average gross annual sales of cosmetics in the U.S. in the previous three years is less than $1 million. As for the adverse event records retention, these small businesses will only be required to maintain records for three years rather than six years.
Adverse Event Reporting
Records pertaining to each adverse event report must be retained for six (6) years.
Records pertaining to each adverse event report must be retained for three (3) years.
However, such exemptions do not apply to responsible persons or facilities engaged in manufacturing or processing any of the following products:
Cosmetics that come into regular contact with mucus membrane of the eye under customary or usual conditions of use.
Cosmetics that are injected.
Cosmetics that are intended for internal use.
Cosmetics that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.
Cosmetic-Drug and Cosmetic-Device Combination Products
In the case of products that are both a drug and a cosmetic, the regulatory requirements outlined in Chapter V: Drugs and Devices of the FD&C Act will apply, but not the cosmetic requirements specified in Chapter VI: Cosmetics. As a result, these products and their manufacturing facilities are exempt from certain cosmetic requirements, including adverse event reporting, GMPs, facility registration, product listing, safety substantiation, general labeling, records inspection, and mandatory recall authority. However, it's important to note that fragrance allergen disclosure and professional use labeling requirements will still be applicable.
Besides, these exemptions do not apply to facilities that manufacture or process both combination products and single cosmetic products that do not fall under the category of cosmetic-drug or cosmetic-device combination products.
9. Talc-Containing Cosmetics, PFAS Report, and Animal Testing
Also, there will be specific guidance provided on other important topics, such as animal testing and the use of ingredients like talc as well as Per- and Poly-fluoroalkyl Substances (PFAS).
Other Important Issues
FDA will propose a rule that establishes standardized testing methods for detecting asbestos in talc-containing cosmetics by Dec. 29, 2023. Final rule will be published by June 2024.
FDA will conduct an assessment of the use, safety, and associated risks of PFAS substances in cosmetic products. The findings of this assessment will be published in a public report by December 29, 2025.
Cosmetic animal testing has not been prohibited. However, MoCRA emphasizes the sentiment of Congress that animal testing should not be employed for safety testing of cosmetic products and should be phased out except in certain special circumstances.
Part 2 New FDA Enforcement Authority
In addition to the new requirements for cosmetic enterprises, the FDA's enforcement authority over cosmetics has also been significantly expanded, particularly in regards to facility registration suspension, records access, and mandatory recall authority.
1. Suspension of Facility Registration
Under the new regulations, FDA is given authority to suspend the registration of a facility if it determines that a cosmetic product manufactured or processed by that facility has a reasonable probability of causing serious adverse health consequences and/or other products manufactured by that facility may be similarly affected.
Once a facility's registration is suspended, it is prohibited from introducing any cosmetic products into the market until its registration is reinstated. FDA will provide prior notice and the opportunity for an informal hearing to the facility registrant before taking such action.
This authority mirrors a similar power granted to the FDA in 2011, which allows for the suspension of food factory registrations.The inclusion of this authority for cosmetic facilities enhances the FDA's ability to swiftly address potential health risks associated with cosmetics produced at specific facilities.
2. Access to Records
When the FDA reasonably believes that a cosmetic product or its ingredients are adulterated and pose a threat of serious adverse health consequences, the FDA will exercise its authority to access and inspect all records related to a cosmetic product.
However, it's important to note that this authority does not apply to certain types of information, including cosmetic recipes or formulas, financial data, pricing data, personnel data (except data on technical and professional personnel qualifications), research data (other than safety substantiation data), and sales data (except shipment data).
Besides, the FDA may request a list of ingredients used in fragrances or flavors if it suspects that a particular fragrance or flavor may have contributed to a serious adverse event.
3. Mandatory Recall Authority
In cases where the FDA determines that a cosmetic product is adulterated or misbranded and its use may lead to serious adverse health consequences, it will first provide the responsible person with an opportunity to voluntarily cease distribution and initiate a recall.
If the responsible person declines to do so or fails to meet the specified requirements, the FDA can order a mandatory recall after granting the responsible person the opportunity for an informal hearing. To ensure transparency and public awareness, the FDA will publish information about the recall through press releases and/or public notices, as appropriate.
Part 3 MoCRA’s Implementation Schedule
The official implementation of MoCRA is set for December 29, 2023. On this date, the majority of the new requirements will take effect, including facility registration, product listing, safety substantiation, adverse event reporting, and professional cosmetics labeling. Cosmetic manufacturing facilities and responsible persons shall make necessary preparations to ensure compliance with these requirements by the deadline.
Over the following years, the FDA will engage in further rulemaking processes concerning fragrance allergen transparency, GMPs, the talc rule, and PFAS reporting. These initiatives will further shape the regulatory landscape and provide additional guidelines for the cosmetic industry.
Enactment of MoCRA
Currently, the detailed rules and the submission portal are not yet available.
Adverse Event Recordkeeping and SAE Reporting
Professional use cosmetics labeling
U.S. contact information labeling for receiving adverse event reports
Fragrance allergen disclosure: FDA will propose a fragrance allergen rule on June 29, 2024, and finalize it after a 180-day comment period.
FDA will issue a draft cosmetic GMP regulation.
FDA will issue the finalized GMP regulation.
FDA will propose a rule for standardized testing methods for asbestos determination in talc-containing cosmetics.
FDA will issue the final rule.
Despite MoCRA's scheduled implementation on December 29, 2023, its preemption provision came into effect immediately. This means that MoCRA holds precedence over any state or local laws that differ from it, specifically in relation to facility registration, product listing, GMP, records, recalls, adverse event reporting, or safety substantiation.
Nevertheless, it is worth mentioning that MoCRA does not prevent states from prohibiting the use or setting limitations on cosmetic ingredients, as exemplified by the California Toxic-Free Cosmetic Act. Furthermore, it does not prevent states from upholding pre-existing requirements that mandate the reporting of certain cosmetic ingredients, as established before the enactment of MoCRA. (e.g., California Safe Cosmetics Act).
For the next 2-3 years, the FDA will dedicate efforts towards developing necessary implementing regulations as mandated by MoCRA. ChemLinked will closely monitor these updates and ensure everyone stays informed about the changes and ongoing developments surrounding MoCRA and its sub-regulations. Please stay tuned with us for the upcoming MoCRA regulatory updates.
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