Let’s Get Ready for MoCRA!

What is MoCRA?

The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 was signed into law by President Biden on December 29, 2022 as part of the 2023 Consolidated Appropriations Act , H.R. 2617. This Act significantly increases the U.S. Food & Drug Administration (FDA)’s oversight of cosmetic and personal care products from the 1938 Federal Food, Drug & Cosmetic (FD&C) Act.

This increased oversight adds important additional obligations on the “Responsible Person” of a “Cosmetic Product” to ensure cosmetic products are produced in a safe and compliant manner. MoCRA defines

• Responsible Person as “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 this Act or section 4(a) of the Fair Packaging and Labeling Act” and
• Cosmetic Product as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.”

Based on these definitions, similar to over-the counter drugs and other more heavily regulated products, the name that appears on the label will be the person responsible for ensuring compliance with these regulations.

MoCRA also provides new authorities to FDA, including the authority to order a mandatory recall (if the responsible person refuses to do so voluntarily) of a cosmetic if the Agency determines that the product is adulterated or misbranded and that serious adverse health consequences or death may result from exposure to the product.

As deadlines for compliance are quickly approaching and add a significant workload to cosmetic producers, we recommend you begin preparing now for compliance. In the below article, SRC Senior Consultant Crystal Maira, outlines the requirements set forth in MoCRA and provides recommendations for compliance.

Is your product a cosmetic?

The distinction between cosmetic and over-the-counter drug products can be confusing. Under the FD&C Act, FDA defines a cosmetic as “an article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.” FDA defines drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Some products may be both a cosmetic and a drug.

For example, a shampoo that claims to “make hair appear fuller” would fall in the category of a cosmetic, while the same product that claims to “treat dandruff” would be a drug product. If the product carries both the cosmetic and drug claims, then both sets of regulations and reporting requirements will apply.

Due to the complex and overlapping nature of these definitions, it can be difficult to determine which regulations apply to your product. The SRC team can assist you with reviewing your product line and label claims to determine which regulations and reporting requirements apply.

Requirements Under MoCRA

Facility Registration and Renewal

Any establishment that manufactures or processes cosmetic products for distribution in the United States must be registered with FDA by December 29, 2023. Foreign establishments who import products to the U.S. must also register their facility and retain a U.S. agent to process their registration. It is anticipated that FDA will not charge a fee for this registration.

Facility registration is not required for establishments that manufacture cosmetics for research purposes only and entities that only relabel, warehouse, distribute, or sell the final product, but are not involved in producing the cosmetic or filling a product container with the cosmetic product.   For example, unlike the registration requirements for drugs, an entity that is shipped prefilled bottles of product and only relabels them would not be required to register the facility under MoCRA.

The registration filing must include the name, physical address, email address, telephone number, U.S. Agent (if a foreign facility), and all brand names and product categories of cosmetics processed in the facility. If your facility is already registered with FDA for production of drug products, your current facility registration number should also be included in the application. Contract manufacturers producing numerous cosmetic products on behalf of more than one responsible person only need to register their facility once. Facility registration is not yet available with FDA under MoCRA.

After December 29, 2023:

Following initial registration, a facility must notify the Secretary of any changes to their name, contact information, brand names produced, product categories, or U.S. agent within 60 days of the change. Additionally, facilities that start producing cosmetics after the deadline will have 60 days to complete their facility registration. All facilities must be reregistered every two years.

FDA may audit or request all applicable records for a registered facility or cosmetic if there is reasonable belief that a product or products is adulterated and may cause serious adverse health risks to consumers. Based on adverse events or audit findings FDA may suspend a facility’s registration, cease distribution, and/or order a mandatory recall. Suspension of a facility registration would also require the reasonable belief that the failure leading to the release of the product causing adverse events is not isolated to the product in question, but may affect other products manufactured by the facility.

Product Listing

Similar to manufacturing and processing establishments, all finished cosmetic products must be listed with FDA by December 29, 2023. This product listing is not expected to incur a fee from FDA and may be submitted as part of a facility registration or as a separate listing. A single submission may include multiple products, if the formula is the same, or only differs in color, size, fragrance, or flavor. FDA does not yet have the systems in place to begin cosmetic product listings at this time.

Listings must include:

• Name and contact information of the Responsible Person
• Facility registration number of each facility processing the cosmetic product
• Name of cosmetic product as it appears on label
• Applicable categories of the cosmetic product
• A list of ingredients in product including fragrances, flavors, or colors
• Any existing product listing numbers, if applicable (this may apply if the product is also registered as a drug)

In preparation for this new registration requirement, FDA stopped accepting submissions through the Voluntary Cosmetic Registration Program (VCRP) on March 27, 2023. Product information previously entered into the VCRP will not transfer to the new program for product registrations. Thus, any registration submitted into VCRP must be re-entered into the new system by the December 29^th deadline.

After December 29, 2023:

Each product listing must be renewed annually and include any changes to the above information that occurred during the year. New cosmetics, marketed after the initial deadline, must submit a listing to FDA within 120 days of marketing the product.

FDA may audit or request all applicable records for a registered facility or cosmetic if there is reasonable belief that a product(s) is misbranded or adulterated and may cause serious adverse health risks to consumers. Based on adverse events or audit findings, FDA may cease distribution or order a mandatory recall if the responsible person does not voluntarily do so.

How to Complete Facility Registration and Product Listing

FDA is in the process of developing the program for cosmetic facility registration and product listing, so there is currently no way to process these registrations. However, we do believe it will be similar to the current process for registering over-the-counter drug products and establishments. We will continue to monitor this development and provide an update once the portal is available for use.

In the meantime, SRC recommends a thorough review of your product line and to begin compiling the required information listed above for your cosmetic products and facilities now in order to be prepared for submission as soon as the site becomes available.

The SRC team has the expertise from doing OTC drug listings, and the availability to process product and facility registrations on your behalf. We are also available to act as the U.S. agent for foreign facilities. Please contact your SRC consultant or follow the link to request a preliminary quote for these services.

Safety Substantiation

All cosmetic responsible persons must maintain records supporting adequate safety substantiation for their products by December 29, 2023. MoCRA defines “adequate substantiation of safety” as “tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe” with “safe” meaning that the product, and any ingredient within the product, is not harmful to the user when used as instructed. This requirement does allow responsible persons to cite existing toxicology data for ingredients used in similar formulas.

SRC recommends developing your safety substantiation plan as soon as possible to allow adequate time to address any data gaps prior to the deadline. The SRC team is happy to assist with your product safety substantiation review and rationale.

Adverse Event Reporting/Record Keeping

Beginning December 29, 2023, records must be kept by the responsible person for each adverse event associated with the use of a cosmetic product in the U.S. These records must be maintained for 6 years (3 years for small businesses). FDA may access these records during inspection.

Additionally, any serious adverse event must be reported, with a copy of the product label, to FDA within 15 business days after receiving notice of the event. MoCRA defines a “Serious Adverse Event” as an event that

‘‘results in death; a life-threatening experience; inpatient hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect; an infection; or significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual; or requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph A.”

Any new and material medical updates occurring within one year of the original serious adverse event must also be reported within 15 business days of receiving notice.

We recommend developing your adverse event reporting and record keeping procedures as soon as possible in preparation for this deadline. Please contact your SRC consultant for assistance with developing adverse event reporting procedures or managing your record keeping for you.

New Labeling Requirements

The below outlines upcoming label requirements and deadlines dictated in MoCRA:

SRC is available to review your label and other marketing literature to ensure that the claims are cosmetic in nature  only and have not accidentally become a drug claim. Our team can also review drug labels to ensure removal of all cosmetic claims to avoid dual jurisdiction if desired

 Cosmetic Good Manufacturing Practices (GMP)

MoCRA requires FDA to develop Good Manufacturing Practices for Cosmetic production facilities by December 29, 2025. A Notice of Proposed Rulemaking will be published by December 29, 2024 to allow a full year for commenting and final approval of the new GMPs.  We will provide updates once the Notice of Proposed Rulemaking has been released.

Talc- Containing Cosmetics

By December 29, 2023, the Secretary of Human and Health Services will promulgate proposed regulations to establish and require standardized test methods for determining the level of asbestos in cosmetics containing talc. According to the regulation, a Final Rule is to be enacted no later than June 2024.

PFAS in Cosmetics

The Secretary of Human and Health Services will assess the use and safety of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetics and publish a report on the FDA website within 3 years of the enactment of MoCRA. Though no FDA cosmetic regulation on PFAS is imminent, many states have enacted legislation prohibiting the use of PFAS in consumer products. SRC recommends removing intentionally added PFAS from product formulas and packaging wherever possible.

Small Business Exemption

Small businesses with less than $1M in average annual sales for the previous 3-year period will be exempt from facility registration, product listing, and GMP requirements. Additionally, small businesses are only required to maintain adverse events records for 3 years. This small business exemption does not apply to responsible parties or facilities for products that:

• Regularly come into contact with mucus membrane of the eye under customary or usual conditions of use
• Injectables
• Products intended for internal use
• Products 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

Deadlines

Though some compliance items are not yet available for implementation at this time, SRC recommends proactively working on the following to ensure you are able to comply with the quickly approaching deadlines:

• Review your product line to determine which products are considered cosmetics under MoCRA.
  • Determine who the responsible person is for each cosmetic.
  • Compile required information for product listings.
• Identify and collect establishment information to prepare for facility registration.
• Begin safety substantiation and data gap analysis. Research available toxicology data to bridge any gaps in safety data or conduct testing, if needed.
• Identify a U.S. agent for foreign facilities.
• Develop a plan and procedure for adverse event reporting.
• Begin updating labels to comply with applicable label requirements.
• Work with fragrance houses to determine the presence of fragrance allergens.
• Determine if you are eligible for a small business exemption.

The SRC team is trained and available to help you with any or all of the above compliance items and preparations. Please let us know how we can assist your team.

 

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Posted 04/12/2023 by:

 

 

Crystal Maira

Senior Regulatory Consultant