On December 29, 2022, US President Joe Biden signed the Consolidated Appropriations Act, 2023 into law, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). 1 This new cosmetic legislation establishes federal standards for cosmetic business registration, product listing, recordkeeping, adverse event reporting, safety substantiation, GMP, recalls, and more.
For years, the US Food and Drug Administration (FDA) had relatively loose regulations on cosmetics. Cosmetics business registration and product listing are voluntary rather than mandatory. FDA can issue a warning letter to cosmetic products or companies involved in violations and deny the entry of such products at ports. Still, FDA has no right to order a mandatory recall of unqualified cosmetics.
Focusing on product safety, MoCRA sets out a number of key provisions and new requirements to amend the Federal Food, Drug, and Cosmetic Act (FD&C Act) and increase FDA’s oversight over cosmetics and ingredients thereof. It marks the first significant reform to the US cosmetics regulation since the enactment of the FD&C Act in 1938.
Some of the key points of MoCRA are summarized below: 2
1. Mandatory Facility Registration and Product Listing
MoCRA stipulates that one year after MoCRA is formally promulgated, "responsible persons" (i.e., manufacturers, packers, and distributors of a cosmetic product whose name appears on the product label) will be subject to mandatory facility registration and product listing requirements.
Specifically, all existing US domestic and foreign facilities that manufacture or process cosmetic products for sale in the United States must register with FDA within one year after MoCRA’s enactment. All facility registrations must be renewed every two years. Notably, facilities engaged solely in the labeling, relabeling, packaging, repackaging, holding, and/or distributing of cosmetic products are not required to register.
Regarding listing, responsible persons shall list each cosmetic product with FDA, including its ingredients and where the cosmetic product is manufactured. The product listings shall be updated annually. It is worth noting that a single listing submission may include multiple cosmetic products with identical formulations or formulations that differ only in colors, fragrances, flavors, or quantity of contents.
2. Cosmetic Safety Substantiation
MoCRA requires responsible persons to ensure and maintain records supporting “adequate substantiation” that shows that a cosmetic product is safe, and establishes a safety standard that products must meet to be marketed in the US. Cosmetic products without adequate safety substantiation will be considered adulterated.
3. Updated Cosmetic Labeling Requirements
MoCRA updates the labeling requirements for cosmetics, including:
- the requirement to include contact information through which the responsible person can receive adverse event reports on cosmetic product labels, which will be effective two years after the date of enactment of MoCRA;
- the requirement to include a notice that only licensed professionals may use the product on the labels of cosmetics products for professional use, which will be effective one year after the date of enactment of MoCRA;
- the requirement for disclosure of fragrance allergens on product labels. The disclosed information shall be consistent with FDA’s new regulations.
4. Mandatory Adverse Event Reporting
MoCRA requires that responsible persons submit reports of serious adverse events to FDA no later than 15 days after learning the issue, and maintain all records related to health-related adverse events associated with the use of its product for six years. Exceptionally, small businesses need only maintain such records for three years.
Besides, MoCRA expands the definition of “serious adverse event” to include infections 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.”
5. FDA’s Increased Oversight
In addition to the above new requirements for cosmetic manufacturers, packers, and distributors, MoCRA greatly expands FDA’s rulemaking and enforcement authority over cosmetics. It mandates FDA to issue good manufacturing practice regulations and develop regulations that establish and require standardized testing methods for asbestos in cosmetics. It also grants FDA’s mandatory recall authority for a cosmetic product and expands FDA’s access to certain records.
ChemLinked Comments
The passage of MoCRA will have a significant and far-reaching impact on the cosmetics industry. As this new legislation involves lots of details, it may take years for FDA to implement and enforce it for several reasons. ChemLinked reminds cosmetics stakeholders interested in entering the US market to study the regulatory changes carefully, and pay attention to the corresponding compliance deadlines, such as facility registration and product listing, which will take effect one year after MoCRA’s enactment. In addition, adequate preparations should be made in advance to mitigate compliance risks and increase the chances of successful market entry.
