Cosmetic regulation in the US has undergone a significant change that companies need to be aware of.
Within the Consolidated Appropriations Act, 2023 that was passed by the US Congress on December 29, 2022, under Subtitle E, it included the “Modernization of Cosmetics Regulation Act of 2022” (MoCRA), which creates new legal requirements for cosmetic companies and new authority for the US FDA. This Act is expected to provide greater FDA oversight and tracking of cosmetics.
Key points in brief:
(Definitions: “responsible person” = manufacturer, packer, or distributor of a cosmetic product whose name appears on the label; “facility” = site of manufacturing or processing but not including entities involved solely in one or more of: labeling, packaging, holding, distributing).
- Facility Registration (Sec. 607(b)): each facility that manufacturers or processes cosmetics for sale in the US, including foreign facilities, must register with the Secretary within 1 year of enactment (by Dec. 29, 2023) and renewed every other year (biennially). Foreign entities must have a US agent on file. New facilities: within 60 days of engaging in such activities. File info includes: name, address, contact details, all brand names, and product categories produced by the facility. Each will receive a facility registration number.
- Product Listing (Sec. 607(c)): each cosmetic product sold in the US is to be listed with the Secretary, within 1 year of enactment (by Dec. 29, 2023). New products (i.e., after Dec. 29, 2022): within 120 days of marketing. Includes: product name, facility reg. number, name and contact number of the responsible person, cosmetic category, list of ingredients (incl. colors, fragrances, flavors). Updated annually.
- Mandatory Adverse Event Reporting and Record Keeping (Sec. 605): The responsible person shall submit to the Secretary within 15 days, any report received of a serious adverse event associated with the use, in the US, of a cosmetic product manufactured, packed, or distributed by such person. FDA previously had no statutory authority to require this and AER were submitted to CAERS voluntarily by any interested party (i.e., consumers, physicians)
- Safety Substantiation (Sec. 608): A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product. Companies were already legally required to ensure their products are safe, but this section provides some additional definitions.
- Current Good Manufacturing Practice for Cosmetics (Sec. 606): FDA must issue mandatory current good manufacturing practice (GMP) regulations for cosmetics. Currently, FDA has only published a guidance for industry. As the guidance was generally based on ISO 22716, it is expected to be carried over. A specific point is made to address flexibility/ simplified GMP requirements for small businesses. Timeline: 2 years for a proposed rule and not more than 3 years for final rule (by 2026).
- Mandatory Allergen Labeling (Sec. 609(b)): cosmetic labels will be required to disclose the presence of fragrance allergens. The list of these allergens will be established by regulation by the Secretary within 18 months of enactment (by ~June 29, 2024 for proposed rule). Likely to follow EU requirements.
- Mandatory Recall (Sec. 611): previously the FDA had no authority under the FD&C Act to order a recall of a cosmetic, although it would request it. This would strengthen FDA’s ability to ensure timely recalls are conducted for misbranded or adulterated cosmetics.
Other points included:
- FDA will promulgate (within 1 year) regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.
- Within 3 years FDA is required to assess the use and safety of PFAS in cosmetics and publish a report on its findings.
- No state preemption in relation to: registration and product listing, GMP, records, recalls, adverse event reporting, or safety substantiation; however, it allows for States to individually prohibit the use or limiting the amount of an ingredient in a cosmetic product as seen fit.
- “The Sense of Congress”: animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances.
There are certain exemptions for small businesses (< $1-million in average gross annual sales for last 3 years) not involved in manufacture/processing: i.e., exempt from product listing requirements and GMP. There may be other requirements and exemptions for various entities that need to be carefully examined, so make sure to review Subpart E in its entirety.
There are many questions about these cosmetic regulation changes and how all of this will be rolled out within the next 12 months, so stay tuned for further FDA updates, regulations, and guidance on this! Any questions – don’t hesitate to reach out.