Modernization of Cosmetics Regulation Act of 2022 (MoCRA), approved by the US Congress on December 29, 2022, will profoundly change the cosmetics regulatory framework in the United States, beginning in late 2023. The United States has until now been known for having few rules for cosmetics and an authority (the Food and Drug Administration – FDA) with little enforcement authority. MoCRA plans to change this by creating a comprehensive framework to regulate all cosmetic products. The law was passed by Congress and signed by the President of the United States. Although MoCRA already contains some concrete elements, many other elements will be communicated by FDA through “Regulations”.

Basic Definitions Under MoCRA

Responsible Person

Responsible Person is the natural or legal person mentioned on the label of the cosmetic product. This person can be any of the manufacturer, packer and distributor, provided that he/she meets the requirements to fulfill the following obligations.

Facility

The term “facility” refers to any establishment that manufactures or processes cosmetic products distributed in the United States. The facility must be registered with the FDA and comply with published US Good Manufacturing Practices.

Safe Cosmetics

The term “safe cosmetic” means that the cosmetic product and its ingredients are not hazardous to the user under the conditions of use recommended on the label or used in a routine and customary manner.

Serious Undesirable Effect

The term serious undesirable effect means an adverse event that results in or requires medical attention to prevent:

• Death or life-threatening situation

• The patient has an infection or is hospitalized

• A permanent or significant injury or disability

• A congenital anomaly or malformation

• Significant cosmetic damage beyond what would be expected under ordinary or customary conditions of use, such as serious or persistent irritation or infection, second- or third-degree burns, significant hair loss, or permanent or significant change

In all these cases, the FDA must be notified within 15 days of the incident.

Key Points of MoCRA

Facility Registration

Existing organizations that manufacture or process cosmetic products distributed in the United States will be required to register their facilities with the FDA by December 29, 2023. New organizations will have 60 days following the marketing of a product to do the registration. Since the FDA needs to set up the system to submit these registrations, the registrations will need to be renewed every two years in any case, although the procedure is not yet known. Non-U.S. entities will be required to designate a U.S. Agent to whom FDA can contact with any questions to facilitate communication in the event of a health emergency, adverse reaction, or possible inspection.

Product Listing

The Responsible Person must issue a product declaration containing product information for all products to be placed on the market. Although the new registration system has not been opened yet, product notifications must be completed by December 29, 2023. The Responsible Person will have to renew product notifications annually and update them in case of changes.

New Labeling Requirements

In conjunction with the new cosmetovigilance system, cosmetic product labels must be updated to indicate one of the following:

• An address in the United States (must be a street address with full street, street and zip code information).

• A phone number in the United States

• An electronic contact information (this could be an e-mail or an online form on a website) from which the Responsible Person can receive information about undesirable effects so that the consumer can submit a report.

The deadline for compliance for existing products is December 29, 2024.

Reporting and Archiving of Serious Adverse Effect Reports

Undesirable effect reporting, which was hitherto voluntary, will become mandatory with MoCRA. Beginning in late 2023, in the event of a serious adverse event associated with a cosmetic product (only if it occurred on U.S. territory), the Responsible Person must submit a report with a copy to the FDA within 15 days.

Adverse reaction reports must be retained for six years and the FDA will have the right to access them, especially during inspections. The FDA may request formula details and a written list of all ingredients in an essence or flavor in the product if it suspects that it may be the cause of a serious adverse effect.

For companies classified as “small businesses” (with an average turnover of less than $1 million in the last three years in the United States), the period for keeping these reports is 3 years.

Good Manufacturing Practices

Until now, GMP was covered by rather vague guidelines, less than 10 pages from 2013. MoCRA requires the FDA to create real regulation by 2025 at the latest. The US administration plans to make a regulation taking an example from ISO 22716 standards. This regulation will allow the FDA to examine companies and inspect the records it deems necessary to determine compliance with GMP. Companies that do not produce in accordance with GMP conditions will be considered "non-conforming".

Product Safety

Companies must provide the necessary documentation to prove the safety of their cosmetic products, and clarification from the FDA is awaited. Again, a product will be considered “Nonconforming” if this requirement is not met.

Product Recalls and Reviews

FDA will have enhanced authority over product recalls. It will thus be able to initiate a mandatory recall (which was not previously within its authority) if:

• There is a reasonable possibility that a cosmetic product may be inappropriate or mislabelled

• Use or exposure to this product may cause serious side effects.

Audits

Until now, the FDA has only inspected OTC manufacturers, but now that all cosmetic companies must be registered, inspections can also occur for relevant companies.

Cosmetics Containing “Talc” or “PFAS”

Any product containing talc will need to comply with a standard testing method determined by the FDA to detect asbestos. PFAS use will need to be evaluated, and elements of scientific review regarding the safety of use and associated risks will be included in the evaluation.