Because No One is Immune to the Law
January 12, 2023 - FDA, Regulatory, United States

Congress Expands FDA Authority Over Cosmetics

MoFo Life Sciences

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed by the U.S. Congress as part of the omnibus Consolidated Appropriations Act enacted on December 29, 2022 and will grant the U.S. Food and Drug Administration (FDA) significant new authority to regulate cosmetics. This is the largest expansion of FDA’s regulatory authority over cosmetics since the Food, Drug, and Cosmetics Act (FDCA) was first enacted in 1938.

As detailed below, MoCRA imposes new requirements on cosmetics manufacturers and processors, grants FDA mandatory recall and other enforcement authorities, and includes additional miscellaneous provisions regarding cosmetics ingredients and testing methods. With a few exceptions, these new requirements and FDA authorities do not apply to products that are both a drug and a cosmetic under the FDCA; drug requirements under the FDCA will still apply to these products.

I. New Cosmetics Requirements

New provisions under MoCRA include specific reporting, manufacturing practices, registration, substantiation, labeling, and record-keeping requirements. Most of these requirements apply to the “Responsible Person,” which is defined as “the manufacturer, packer, or distributor of a cosmetics 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.”

Adverse Event Recording and Reporting Requirements. MoCRA imposes adverse event reporting requirements similar to other requirements for drugs and dietary supplements. A Responsible Person must have the capability to receive adverse event reports from consumers through contact information provided on the product label. Records for adverse event reports must be kept for at least six years. The Responsible Person must report any “serious adverse event” to FDA within 15 days of receiving such a report.

In addition, FDA may request a list of ingredients in fragrances or flavors of a product if it has reason to believe the fragrance or flavor contributed to a serious adverse event.

Good Manufacturing Practices. MoCRA instructs FDA to develop and propose regulations, within two years of MoCRA’s enactment, for good manufacturing practices that will be imposed on cosmetics manufacturers and processers. These regulations must take into account the size and scope of businesses in order to provide flexibility for all sizes and types of facilities to comply with the eventual requirements.

A product that is not manufactured or processed according to the eventual regulations is an adulterated product under the FDCA (21 U.S.C. § 361). But small businesses, defined as those businesses that don’t manufacture or process cosmetics and have average gross annual sales totals that are less than $1 million over the previous three-year period, will not be subject to the good manufacturing practices regulations.

Facility and Product Registration. Each “Facility,” defined in MoCRA as any organization that manufacturers, processes, or imports cosmetic products that are distributed in the United States, must register with FDA within one year of MoCRA’s enactment. Any new Facility following MoCRA’s enactment must register within 60 days after its operations first begin. A Facility’s registration must include: (1) the Facility’s name, address, and contact information; (2) brand names of the cosmetics that the Facility manufactures or processes; (3) categories of products that the Facility manufactures or processes; and (4) the Responsible Person for each cosmetic product manufactured or processed at the Facility. Facilities will be required to renew their registration biennially. Small businesses, however, do not have to register with FDA.

Product Safety Substantiation. The Responsible Person for each cosmetic product must ensure the safety of each product is adequately substantiated with “tests or studies, research, analyses, or other evidence or information … sufficient to support a reasonable certainty that a cosmetic product is safe.” The Responsible Person must maintain records supporting substantiation.

A cosmetic product, or ingredient in a cosmetic product, that does not have adequate substantiation for safety is an adulterated product under the FDCA (21 U.S.C. § 361).

Labeling Requirements. Two years after MoCRA’s enactment, the label for each cosmetic product will have to include (1) the Responsible Person’s address, phone number, or email through which they receive adverse event reports; and (2) each fragrance allergen included in the product. MoCRA requires labels for professional cosmetics products to include the same information as above, and to also state that only licensed professionals may use the product.

A cosmetic product that does not meet these labeling requirements will be deemed misbranded under the FDCA (21 U.S.C. § 362).

II. New FDA Enforcement Authorities

To enforce new and existing cosmetics regulations, MoCRA grants FDA authority to issue a mandatory recall, order a Facility to cease distribution by suspending the Facility’s registration, and access a Facility’s records.

Mandatory Recall Authority. MoCRA grants FDA mandatory recall authority if it determines:

  1. There is “a reasonable probability that a cosmetic is adulterated … or misbranded”; and
  2. The “use of or exposure to such cosmetic will cause serious adverse health consequences or death.”

FDA will provide the Responsible Person with an opportunity to voluntarily cease distribution of or recall the cosmetic product before issuing a mandatory recall.

Facility Registration Suspension Authority. 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.”

Access to Records Authority. FDA can request access to any record related to a cosmetic product if it reasonably believes that the product or an ingredient in the product is “likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans.” This does not include records related to cosmetic product formulas or recipes, or to the Responsible Person’s financial, pricing, sales, personnel, or research data unrelated to safety substantiation documents.

III. Additional Provisions

Preemption. Any state or local law is preempted to the extent that it differs from the provisions in MoCRA that are related to “registration and product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation.” Notably, MoCRA does not preempt a state’s authority to prohibit, limit, or report the use of an ingredient in cosmetic products.

Talc-Containing Cosmetics. Within one year of MoCRA’s enactment, FDA is required to propose regulations to establish and require testing methods for detecting and identifying asbestos in talc-containing cosmetics.

PFAS in Cosmetics. MoCRA directs FDA to assess the use and safety of including perfluoroalkyl and polyfluoroalkyl substances in cosmetics. FDA is required to publish a report summarizing its findings from this assessment.

Animal Testing. MoCRA includes a “sense of the Congress” that “animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with exceptions.” MoCRA did not include any new rules or directives regarding the use of animal testing.

FDA Appropriations. MoCRA authorizes the setting aside of significant funds as appropriations to implement the new requirements and authorities.

  • FY 2023: $14.2 million
  • FY 2024: $25.96 million
  • FYs 2025–2027: $41.89 million (per year)

But MoCRA does not include any actual appropriations, so without the additional resources and staffing from the appropriations, any regulatory implementation or reform under MOCRA will have to compete with the current initiatives run by the FDA Center for Food Safety and Applied Nutrition.

IV. Takeaways

Companies that manufacture, process, and sell cosmetics should review their policies and procedures in light of MoCRA to ensure they are prepared for the implementation of these new requirements. They may need to take a significant look at current practices to determine what changes need to be made. For example, companies should scrutinize their systems related to consumer reporting to ensure they have the capability to receive, evaluate, and report potential serious adverse events. Implementing best practices regarding consumer reports now can help avoid a future product recall and, potentially, significant civil penalties.