Recently, the US laws for cosmetics have changed. They have been made comprehensive. The Modernization of Cosmetics Regulation Act (MoCRA) has been implemented to modernize and transform FDA cosmetic regulations. The aim is to improve product safety and protect consumer health. Under this act, new facility rules, product listings, SAE provisions, and safety validations have been introduced. Thus, cosmetics manufacturers or processors need to understand and comply with the MoCRA guidelines. Notably, the MoCRA has introduced the new era of cosmetics regulations. In this detailed guide, we will walk you through the nitty-gritties of MoCRA.    

US Modernization of Cosmetics Regulation Act terms explained

The Modernization of Cosmetics Regulation Act has introduced new terms. Thus, to help cosmetics manufacturers and distributor, we have provided a brief explanation of the terms mentioned in MoCRA guidelines.

• Responsible person: The responsible person is the distributor, packer, or manufacturer of a cosmetic product whose name appears on the product’s label in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.
• Adverse event: Any adverse health-related event or consequence caused by using the cosmetic product.
• Serious adverse event: An adverse event that leads to infection, inpatient hospitalization, life-threatening experience, congenital anomaly or birth defect, significant disability or incapacity or disfigurement, or even death.
• Facility: Any establishment that manufactures or processes cosmetic products distributed in the United States is a facility.

6 Key Modernization of Cosmetics Regulation Act (MoCRA) requirements

1. Cosmetics product listing: The responsible person will be required to annually update each marketed cosmetic product with the FDA. They are required to provide information on product ingredients.
2. Safety substantiation: Companies and individuals who manufacture or market cosmetics have the responsibility of ensuring their product safety. The Modernization of Cosmetics Regulation Act requires the responsible person to maintain records proving product safety and efficacy. Notably, products lacking proper safety substantiation will be considered as misbranded and adulterated. Hence, it is the responsible person’s duty to ensure there is adequate safety substantiation for their products. Additionally, they should have their cosmetics products evaluated for safety by a qualified expert.
3. Adverse events reporting: MoCRA guidelines mandate the responsible person to promptly report any serious adverse event that may have occurred upon the use of the cosmetic product in the U.S. This should be reported to the FDA within 15 business days. Furthermore, additional medical information must be shared within 1 year. Moreover, U.S. companies are required to retain adverse event records for the cosmetic product usage for 6 years (3 for small businesses).
4. Cosmetics facility registration: According to MoCRA guidelines, all existing facilities that produce cosmetics have to be registered with the USFDA within December 29, 2023. On the other hand, new cosmetics facilities must register on the FDA platform within 60 days of inception. Furthermore, the facility registration has to be renewed every 2 years. If the facility poses a risk of serious adverse event, the FDA may suspend the registration of this facility.
5. MoCRA cosmetics labelling requirements: As per MoCRA requirements, contact information for reporting adverse effects has to be mandatorily mentioned on the label. A domestic address, phone number or electronic contact information where the adverse events can be reported by consumers should be mentioned. Additionally, fragrance allergens have to be flagged. Moreover, professional cosmetics must be clearly labelled, with the indication they are intended for use only by licensed professionals.  Furthermore, compliance with all existing cosmetics product labelling requirements is also necessary.
6. Cosmetic good manufacturing practices: The good manufacturing practices guidelines have been formulated to ensure high-quality cosmetics are consistently manufactured. Thus, production of adulterated cosmetics can be avoided. Hence, the aim of protecting the consumer health can be achieved. MoCRA guidelines require cosmetics facility to abide by GMP guidelines. Furthermore, this regulation allows the US FDA to inspect facilities and access necessary records to verify GMP compliance.

New FDA authorities introduced by MoCRA guidelines

MoCRA has provided the following new authorities to the FDA:

• Recall authority: MoCRA has bestowed FDA with the power to mandatorily recall cosmetics products. The FDA has the power to evaluate cosmetics products for adulteration, misbranding, and serious adverse event risk. If the product is found at risk and the responsible person does not voluntarily recall it, FDA has the power to order a recall.
• Records access: MoCRA has also bestowed the FDA with the power to access cosmetics product-related records. Under certain conditions, the FDA has the power to access and copy certain related records, including safety records.

Exemption under MoCRA guidelines

Certain exemptions under MoCRA guidelines exist for small businesses. Any business whose average gross annual cosmetic products sales for the previous 3 years is less than USD 1 Million in the US is consider a small business. These businesses are exempt from GMP, facility registration, and product listing requirements of the Modernization of Cosmetics Regulation Act.

To be eligible for the exemption, the business should not be involved in manufacturing/processing cosmetic products that can be injected. Additionally, the products should not alter appearance for more than 24 hours without consumer removal. Neither should they come into contact with the eye’s mucus membrane. Furthermore, they should not be intended for internal use.

What are the new provisions and requirements introduced by MoCRA guidelines?

1. Modernization of Cosmetics Regulation Act mandatory adverse event reporting requirements: Responsible parties are required to report adverse events associated with cosmetic products within 15 business days of the incidence. Notably, the adverse event reports must include a copy of the cosmetics product label on or in the retail packaging. Furthermore, for 1 year after the initial submission, new medical information related to the initial report has to be submitted.
2. Cosmetics facility registration and renewal: New cosmetics facilities are required to register with the FDA within 60 days of marketing their products. Whereas, existing cosmetics facilities have to register with the FDA within 1 year of MoCRA’s enactment. Furthermore, cosmetics product facility owners and operators have to renew their registration every 2 years. Thus, timely registration and renewal are crucial to abide by FDA cosmetics requirements.
3. Mandatory cosmetics product listing submission: Cosmetics product businesses are required to provide a comprehensive list of all marketed products within 1 year of MoCRA’s enactment. Furthermore, for products marketed after the MoCRA enactment, a complete listing has to be submitted to the FDA within 120 days of marketing. Additionally, using a flexible submission form, list of similar cosmetics products with minor variations can be submitted. Notably, annual updates of these listings are required.
4. Cosmetics product labelling requirements: MoCRA guidelines require the cosmetics label to include a domestic address, phone number, or electronic contact information of the responsible person for receiving adverse event reports from consumers. Additionally, fragrance allergens should be mentioned on the labels. Furthermore, professional cosmetics must be clearly labelled. In addition to Modernization of Cosmetics Regulation Act labelling guidelines, existing cosmetics labelling guideline compliance is also a necessity.
5. MoCRA cosmetics good manufacturing practices (GMP) requirements: Cosmetics manufacturing facilities are required to meet GMP benchmarks while manufacturing cosmetics.
6. MoCRA safety substantiation requirements: Cosmetics companies are required to maintain records supporting the safety of their products. The substantiation records can include tests, studies, or analyses deemed sufficient by qualified industry experts.
7. Modernization of Cosmetics Regulation Act mandatory record-keeping requirements: The MoCRA guidelines mention record keeping requirements. Adverse event records must be kept for a minimum of 6 years. Additionally, if requested, they should be provided to the FDA during inspections.

Pharmadocx Consultants: Your trusted MoCRA compliance partner 

Modernization of Cosmetics Regulation Act guidelines are extensive. Navigating through the guidelines is not an easy task. As cosmetics manufacturers, packers, and distributors, it is not possible to stay abreast of all the MoCRA guidelines. Fret not! Our team of experts will be more than happy to help you in every step of your regulatory journey. Simply drop an email at [email protected] or call/Whatsapp on 9996859227 to get started.