If you are involved in the manufacture or distribution of cosmetic products in the U.S., you may have recently heard of MoCRA. If you haven't, read on. (Hint: It’s not some tasty new drink at Starbucks.) MoCRA is an acronym for the Modernization of Cosmetics Regulation Act of 2022 which was signed into law on December 29, 2022. As discussed in this article, MoCRA imposes new requirements on entities that manufacture, process and distribute cosmetic products in the United States. Some of those requirements will be effective by the end of this year, so it's not too early to begin preparing.

‍Facilities & Responsible Persons.

‍MoCRA and the regulations that will be promulgated impose regulatory requirements on “Facilities” and “Responsible Persons.” A “Facility” is any establishment, including those located in foreign countries, that manufactures or processes cosmetic products that are distributed in the U.S., although there are some key exceptions: i) cosmetic products retailers, including individual sales representatives, direct sellers, and retail distribution facilities; and ii) establishments that solely perform labeling, relabeling, packaging, repackaging, holding, or distributing.

A “Responsible Person” is the manufacturer, packer, or distributor of a cosmetic whose name appears on the label under the “Distributed By” or “Manufactured For” designations. If your firm distributes cosmetics, your firm is a Responsible Person.

The responsibilities of cosmetic firms under MoCRA will vary depending on whether the entity is the operator of a Facility or is the distributor of a cosmetic product (aka a Responsible Person).

‍Product Listing.

‍This is where MoCRA becomes burdensome for firms that merely distribute cosmetics as EVERY beauty business is required to submit a product listing for each cosmetic product that the company distributes in the U.S. The listing for each product must include:

• The Facility Registration Number of each Facility where the product is manufactured or processed. Thus, the Facility registration obligations impact the distributor;
• The name and contact number of the Responsible Person (the Distributor) and the name of the product as it appears on the label;
• The applicable cosmetic category or categories for the product;
• A list of the ingredients in the product, including fragrances, flavors, and colors; and
• The product listing number previously assigned by FDA, if any. For the initial listing, there will be no listing number.

The deadline for submission of the product listings to the FDA is December29, 2023. For products introduced after December 29, 2022, the product listing must be submitted to the FDA within 120 days of marketing the product in the U.S. However, the initial impact is more immediate. Because labels oftentimes must be ordered a year or more in advance, Facilities that a seller uses to manufacture goods should register as soon as possible so the Facility Registration Number(s) can be included in the product listings.

If you were thinking that you would immediately jump on listing your products, hold your horses. In typical government fashion, the processes and procedures for submitting product listings to FDA have not yet been implemented.

 Product listings will need to be renewed pursuant to an abbreviated renewal process that the FDA has not yet implemented. If there are any changes to the information submitted in a product listing, the company must submit an updated product listing. For example, if a product listing is submitted without a Facility Registration Number, it will be necessary to update as soon as the Facility Registration Number is known. Similarly, if there is a formulation change, the product listing will need to be updated.

‍Serious Adverse Event Reporting.

‍The dietary supplement industry has been subject to Serious Adverse Event Reporting (“SAER”) obligations for years. SAER obligations are now coming to the cosmetics world!  A “serious adverse event” is any health-related event associated with use of a cosmetic 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). A Responsible Person who receives a report of a serious adverse event from a consumer that is associated with the consumer’s use of the Responsible Person’s product must submit a Serious Adverse Event Report to FDA within 15 business days of its receipt of a report of such an event. The report must include a copy of the label of the product. If new information is learned after a SAER, the Responsible Person must submit the new information to FDA within 15 business days from the receipt of the new information. There are also document retention requirements. For each Serious Adverse Event Report that it submits to FDA, the Responsible Person must maintain all records (including medical records) related to each SAER for six years and permit FDA to inspect the records during any inspection of its premises. The obligation on sellers to submit SAERS to FDA becomes effective on December 29, 2023.

‍Label Requirements.

‍The looming deadlines are tough, but for sellers, printing deadlines must be taken into account. MoCRA requires that the full U.S. mailing address, U.S. telephone number, or electronic contact information (an email address or URL) be included on product labels. The purpose of this requirement is to provide consumers with a means to report adverse events to the company. This requirement becomes effective on December 29, 2024.  

MoCRA also requires that fragrance allergens be identified on cosmetic product labels. MoCRA directs FDA to issue a regulation that lists the fragrance allergens that must be disclosed. FDA has until June 29, 2024 to issue a notice of proposed rulemaking regarding this requirement. They then have 180 days from the date on which the public comment period on the proposed regulation is closed to issue a final rule. Given the pace at which FDA operates, don’t be surprised if this deadline gets pushed out several years. We are just going to have to wait on this one. Hopefully, FDA provides us with sufficient lead time to comply with this labeling requirement.

‍Safety Substantiation.

‍Effective December 29, 2023, MoCRA imposes an obligation on the Responsible Person to ensure that there is adequate substantiation of the safety of its products and to maintain safety substantiation records. “Adequate substantiation of safety” are 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. “Safe” means that the cosmetic product is not injurious to users under the conditions of use prescribed in the labeling or under customary use. Note that under MoCRA, an ingredient or product is NOT injurious to users solely because it can cause minor and transient reactions and skin irritations in some users.

‍Good Manufacturing Practices.

‍MoCRA requires that FDA promulgate Good Manufacturing Practices (“GMP”) regulations for Facilities by December 29, 2024, and a final rule no later than December 29, 2025. Again, given the glacial pace at which FDA moves, don’t be surprised if the GMP regulations are delayed for some time.

What You Should Do Now.

‍While some of the requirements imposed by MoCRA are in the future and firms are not able to comply with them at this time, (e.g., Facility Registrations, Product Listings, GMPs), there are things that you should be doing now to ensure that you are ready:

• Begin implementing your SAER policies and procedures. At a minimum, you will need to have policies, procedures, and training in effect to enable the company to determine what consumer adverse event reports are serious and therefore must be reported to FDA. Among the immediate decisions are: Who at the company will be responsible for that determination? Who will be responsible for submitting the SAER reports? How will records be maintained?
• To the extent that they do not currently have it, companies need to begin gathering substantiation for the safety of their products and develop policies and procedures for record maintenance. Be aware that upon the effective date of this requirement, a failure by a Responsible Person to demonstrate adequate substantiation of safety of a product can cause the product to be “adulterated” under the Food, Drug and Cosmetic Act and therefore subject the company to enforcement proceedings. Moreover, a lack of adequate substantiation of safety will be a gold mine to plaintiff’s lawyers and class action attorneys.
• Review label inventories & design new labels that contain the Company’s full contact information.
• Compile the information needed for product listings so that they can be timely submitted to the FDA when submission becomes possible.
• Ensure your manufacturers register with the FDA (recall that your product listings must include the manufacturer’s registration number).

‍Deadlines.

To recap, here are the deadlines for Facilities and Responsible Persons imposed by MoCRA:

• ‍Facility – Current Facilities Registered –December 29, 2023.
• ‍Facility – New Facilities Registered – Within 60 days of commencing manufacturing or processing activities or by February 27,2024, whichever is later.
• Facility – GMPs - Pending.
• ‍Responsible Person – Product Listings Submitted, Current Products – December 29, 2023.
• ‍Responsible Person – Product Listings Submitted, New Products – Within 120 days of marketing the product in the U.S.
• ‍Responsible Person – Serious Adverse Event Reporting and Recordkeeping – December 29, 2023.
• ‍Responsible Person – Contact Information on Labels – December 29, 2024.
• ‍Responsible Person – Labeling of Fragrance Allergens – Pending.
• ‍Responsible Person – Safety Substantiation – December 29, 2023.

‍Questions?

If you have questions about complying with MoCRA, feel free to reach out to us. We would be happy to have a discussion with you.