A Facelift for Cosmetics: Modernization of Cosmetics Regulations Act of 2022
As 2022 came to an end so too did the cosmetic industry’s comfortable position largely outside FDA regulation. The federal Food Drug and Cosmetics Act (FDCA) is the foundational law governing everything that goes on, in, or comes in contact with anything that goes on or in humans or animals, and for decades cosmetic products have been largely outside of FDA’s regulatory scheme – until now.
While the law may be new, the issue has been brewing for decades. FDA Commissioner Robert Califf explained the issue in a June 2017 article for JAMA.
“The debate about regulation of the cosmetics industry to protect the public health has gone unresolved for more than a century. Unlike drugs and devices used for diagnosis and treatment, Congress has never required cosmetic manufacturers to obtain premarket approval before selling a new product…. Nor does any regulatory body evaluate claims about the safety or effectiveness of these products. The FDA’s role with regard to cosmetics is thus similar to that of police, who can act only if they become aware of something that gives them ‘probable cause’ to investigate. The challenge for regulators is daunting…”
Buried in the middle of the 4155-page Consolidated Appropriations Act of 2023 is the “Modernization of Cosmetics Regulation Act of 2022” (MOCRA), requiring registration and providing enhanced FDA oversight for cosmetic products.
Cosmetic: The term ‘cosmetic product’ was already defined under the FDCA as (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap (21 U.S.C. 321(I)). MOCRA focuses the definition on finished products defining cosmetic as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.”
Facility: The term “facility’ is defined to include any establishment (including an establishment of an importer) that manufactures, or processes cosmetic products distributed in the United States.”
Responsible Person: The term ‘responsible person’ means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product under the Act of the Fair Packaging and Labeling Act. Under MOCRA, the designated Responsible Person is the point person for the FDA.
MOCRA excludes beauty shops, retailers, medical providers, hotels, labelers, packagers, and distributors. The Act further provides small business exemption from certain registration and good manufacturing requirements, except for injectables, ocular products, internally applied or products that alter the appearance for more than 24 hours.
One year – Registration: By Dec. 31, 2023, existing “Facilities” must register and every two years thereafter. For contract-manufactured products, a single registration may be submitted by either the contract manufacturer or the “Responsible Person” for the “manufacturer” (i.e., the entity whose name is on the product). The registration must include brands, product categories, and product listing, including ingredients, fragrances, and colors, but not formulas or recipes.
Two years – GMP: By Dec. 31, 2024, FDA is required to publish good manufacturing practice regulations generally conforming to international standards. Whether FDA will meet this deadline is unknown but, with history as a guide, the regulations will not likely be issued any sooner.
18 months – allergens: The FDA is required to issue a proposed rule within 18 months identifying fragrance allergens.
One year – asbestos: FDA has until January 2024 to propose regulations for testing to detect asbestos in talc-containing cosmetics. Asbestos is naturally found in or near talc and may be present in body powders, facial powders, and eye shadow. FDA has issued consumer advisories in the past regarding certain cosmetic products for the presence of asbestos.
Three years – PFAS: FDA has until January 2026 to “publish its report on the assessment of the use of PFAS in cosmetic products and the scientific evidence regarding the safety of such use in cosmetic products, including any risks associated with such use. In conducting such assessment, the Secretary may, as appropriate, consult with the National Center for Toxicological Research.” Per- and polyfluoroalkyl substances (PFAS) are man-made chemicals widely used or added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara. PFAS may also be present in cosmetics unintentionally as the result of raw material impurities or due to the breakdown of PFAS ingredients that form other types of PFAS. PFAS are used to condition and smooth the skin, making it appear shiny, or for product consistency and texture.
Animal Testing: Congress found “it is the sense of Congress that animal testing should not be used” for safety testing and should be phased out but “with the exception of appropriate allowances.”
Cosmetics are now subject to adverse event reporting and a 15-day reporting requirement for serious adverse events. Adverse event records must also be maintained for six years.
Cosmetic manufacturers are now required to demonstrate an “adequate substantiation of safety.” The term “adequate” is defined to mean testing, research, or other evidence. For “substantiation” FDA relies on the standard the Federal Trade Commission has applied requiring “competent and reliable scientific evidence” to support claims of benefits and safety. The term “safe” is generally and broadly defined as requiring that a cosmetic ingredient or cosmetic shall not be considered “injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users.”
Recalls: MOCRA brings cosmetics into the fold of FDA-regulated products subject to mandatory recall authority. For cosmetic manufacturers, this authority will require due diligence in auditing suppliers and manufacturers and ensuring insurance and the ability to handle a recall.
Prohibited Acts: Section 331 is also amended to ensure a violation is a “prohibited act,” which is subject to criminal sanctions. The Act gives FDA power to suspend a registration that renders a manufacturer incapable of doing business.
As the marketplace strives for newer, more complex, novel, and effective ways to improve the appearance of humans and animals, FDA has a daunting task of keeping up. Prior to MOCRA, the cosmetics industry was not exempt from oversight, regulation, and enforcement for adulteration and mislabeling. What the law does accomplish is to provide FDA and its state partners with a roadmap to what is in the marketplace and an efficient mechanism for removing products that do not comply.
The changes to the law under MOCRA are not merely “cosmetic” and, as with any significant change in the law and regulatory framework, it is not what you know but what you do not know that causes time consuming and expensive business disruption. Reach out with questions and for guidance before a compliance issue arises to ensure compliance, no disruption, and peace of mind.
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