MoCRA Compliance Deadline: December 29, 2023

If you are a cosmetic brand or cosmetic manufacturer and have distributed or marketed cosmetics in the U.S. prior to December 29, 2022, you have important MoCRA compliance requirements to meet by December 29, 2023.

On December 29th, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) into law, which included the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

MoCRA added Section 607 to the Federal Food, Drug, and Cosmetic Act (FD&CA) to establish requirements for cosmetic product facility registration and product listing. It enhances the FDA's authority, establishes a uniform national framework, and promotes safety and innovation.

Cosmetic brands and manufacturers who have distributed or marketed cosmetic or personal care products in the U.S. on December 29, 2022 and after have requirements to be made by the FDA this year.

What goes into effect December 29, 2023?

Not all requirements go into effect in 2023, but there are important requirements under MoCRA which are required to be met by December 29, 2023:

Cosmetic Safety Substantiation

Adverse Event Recordkeeping & Serious Adverse Event Reporting

Mandatory Facility Registration & Product Listing

Cosmetic Labeling (for Professional Use Products)

New FDA Enforcement Authorities: Mandatory Recall / Cease Distribution Authority

Cosmetic Safety Substantiation

In Sec. 608, MoCRA requires a Responsible Person to ensure adequate substantiation of the safety of each cosmetic product, and maintain records supporting adequate substantiation of safety of the cosmetic product.

The Responsible Person is a new concept in the U.S. The U.S. FDA defines a 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 the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.”

A new concept is introduced here and that is the concept of “adequate substantiation of safety” which means tests, 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.”

Another key term is “safe.” The term is defined in the Act by FDA as “cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual.” The Act further states,  FDA “shall not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users.”

FDA can review cosmetic safety substantiation documentation if they have a “reasonable belief that the cosmetic product is likely to be a threat of serious adverse health consequences or death.”

It is recommended that you request a trained and certified toxicologist to conduct a Toxicological Risk Assessment on your products to assess risks your products may have, and establish a safety substantiation policy to address these new requirements.

Adverse Events and Serious Adverse Events

Mandatory Facility Registration & Product Listing

By December 29, 2023, all cosmetic facilities must be listed with the FDA, and all cosmetic products marketed in the U.S. on December 29, 2022, must be listed with FDA.

In general, individuals who own or operate a "facility" involved in the manufacturing or processing of cosmetic products for distribution in the United States are required to register with FDA. The terms "facility" and "manufacturing or processing of a cosmetic product" are defined in the Draft Guidance. There are exceptions to the definition of "facility," including beauty shops, salons, and retailers (unless they manufacture or process cosmetics). Additionally, establishments that solely engage in activities such as labeling, relabeling, packaging, repackaging, holding, and distributing of cosmetic products are exempted, except for filling a product container, which triggers registration. Small businesses and facilities registered under the drug or device provisions of the law may also qualify for exemptions.

If a facility manufactures or processes cosmetic products on behalf of a Responsible Person (such as a contract manufacturer), only one registration is required for that facility. This applies even if the facility also manufactures or processes its own cosmetics or works with multiple Responsible Persons. In such cases, the Responsible Person whose products are manufactured or processed at the facility may submit the facility registration. This means that the Responsible Person for the contract manufacturing facility does not need to separately register the facility.

If you are a manufacturer located outside of the U.S., you are require to have a U.S. Agent designated and identified in the facility registration. This U.S. Agent is different than the Responsible Person. A U.S. Agent must be physically located in the U.S. and will function as the main point of contact for FDA. The U.S. Agent does not have to be an employee or entity of the manufacturer, and can be a designated individual or entity with whom FDA can correspond.

For a cosmetic product to be listed, it must be submitted by the Responsible Person, or a designated individual or entity on behalf of the Responsible Person. The “Responsible Person,” as defined in MoCRA, means the manufacturer, packer or distributor whose name appears on the label of the cosmetic product. There are exemptions from listing requirements, including for small businesses and for combination cosmetic/drug, such as an OTC sunscreen or acne product, or cosmetic/device products, previously listed.

All cosmetic products marketed on December 29, 2022, must submit a cosmetic product listing not later than December 29, 2023. For cosmetic product first marketed after December 29, 2022,  a cosmetic product listing must be submitted within 120 days of marketing such product in interstate commerce or within 120 days of December 29, 2023, whichever is later.

FDA has released Draft Guidance for Industry assist in cosmetic product listing and facility registration. “FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities,” states the FDA.  “Instead, guidances describe [FDA] current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidances means that something is suggested or recommended, but not required.”

Mandatory Recall / Cease Distribution Authority

On December 29, 2023, FDA has new authorities. FDA can access and copy certain records related to a cosmetic product, including safety records. In the event “the agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of or exposure to the cosmetic will cause serious adverse health consequences or death, FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily.”

This significant new authority allows FDA greater ability to regulate cosmetics in the U.S.

FDA will provide the Responsible Person with an opportunity to voluntarily cease distribution of or recall the cosmetic product before issuing a mandatory recall. A Responsible Person can appeal this in a requested informal hearing prior to a mandatory recall.

FDA may suspend a Facility’s registration, requiring the Facility to cease distribution of all cosmetic products, if FDA:

(1) Determines a cosmetic product manufactured or processed by the Facility has a “reasonable probability” of causing serious adverse health consequences; and

(2) Reasonably believes that “other products manufactured or processed by the Facility may be similarly affected” due to an unidentified or pervasive issue that could affect other products.

Before suspending a Facility’s registration, FDA will provide notice and an opportunity for the Facility to be heard at an informal hearing. A suspended Facility must submit a corrective action plan to FDA covering how it will address the issue, but a Facility’s registration will be reinstated only once FDA determines “adequate grounds do not exist to continue the suspension actions.”

It is recommended to review your current policies and procedures in light of this new authority. Implementing best practices can help avoid a future product recall and, potentially, significant civil penalties.

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