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January 25, 2023
The new year is here and, as we settle into 2023, big changes to the federal regulation of cosmetics are on the way.
In the last days of 2022, President Biden signed the $1.7 trillion omnibus spending bill—formally known as the Consolidated Appropriations Act of 2023—into law. The legislation, which will fund the federal government through September 2023, contains numerous provisions related to FDA, including the Food and Drug Omnibus Reform Act of 2022 (FDORA).
FDORA expands FDA authority to regulate drugs, medical devices and cosmetics—among other product categories—by making significant amendments to the Federal Food, Drug, and Cosmetic Act (FDCA). For cosmetics specifically, FDORA contains the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This landmark legislation significantly overhauls the regulatory framework for cosmetic products.
MoCRA establishes federal standards for cosmetics with respect to facility registration, safety substantiation, good manufacturing practices, adverse event reporting, and more. Though such requirements are not new to dietary supplements and other FDA-regulated product categories, cosmetics will soon be subject to regulatory oversight by FDA unlike ever before.
New and expanded regulatory requirements for cosmetics include, but are not limited to:
- Facility registration: All existing cosmetic product facilities (i.e., establishments that manufacture or process cosmetic products distributed in the U.S.) generally must be registered with FDA by Dec. 29, 2023—that is, within one year of enactment of MoCRA. New facilities must register within 60 days of first engaging in manufacturing or processing cosmetic products for distribution or 60 days after the deadline for existing facilities, whichever is later. Facility registrations must be renewed biennially, and updates to registration information are required within 60 days of the relevant changes. FDA will assign a registration number to each registered facility. Prior to MoCRA, registering establishments that manufacture or package cosmetic products with FDA was voluntary, though registration has been required for food facilities, including dietary supplements, since 2003.
- Product listing: For each cosmetic product, a responsible person—defined as “the manufacturer, packer or distributor of a cosmetic product whose name appears on the label of such cosmetic product”—generally must submit a listing that includes, among other things, the product’s ingredients and where it was manufactured or processed. The responsible person must submit the listing by Dec. 29, 2023—within one year of enactment of MoCRA—for existing cosmetic products and within 120 days of entering interstate commerce for new cosmetic products. FDA will assign a product listing number to each listed cosmetic product. MoCRA does not include any requirement that FDA affirmatively make these product listings publicly available. Prior to MoCRA, there was no listing requirement for cosmetic products; however, establishments could voluntarily file ingredient composition statements with FDA.
- Safety substantiation: A responsible person generally must ensure and maintain documentation that supports the adequate substantiation of safety for each cosmetic product. Failure to comply could render a cosmetic product adulterated and subject to FDA enforcement action. Prior to MoCRA, no such safety substantiation requirements existed for cosmetics.
- Good manufacturing practices (GMPs): FDA must develop regulations establishing GMPs for cosmetic facilities to protect the public health and ensure cosmetic products are not adulterated. The agency must publish a proposed rule within two years of enactment of MoCRA and issue a final rule within three years of enactment. Failure to comply with GMP requirements could render a cosmetic product adulterated and subject to FDA enforcement action. Prior to MoCRA, there were no GMP requirements for cosmetics, though GMPs have been long established for drugs, foods and dietary supplements.
- Adverse event reporting: Each cosmetic product must include contact information on the label through which a responsible person can receive adverse event reports. A responsible person must submit to FDA reports of all serious adverse events—for instance, those that result in death, a life-threatening experience or serious disfigurement—associated with the use (in the U.S.) of a cosmetic product manufactured, packed or distributed by the person within 15 business days of the report. The responsible person must maintain records of adverse events for six years (or three years for small businesses that do not engage in manufacturing or processing). In addition, within 15 business days of receipt, a responsible person must update reports with “new and material medical information” received about a previous report within one year of the initial report to FDA. If the agency believes ingredients in a fragrance or flavor caused the serious adverse event, a responsible person must provide a complete list of ingredients in the specific fragrances or flavors to FDA within 30 days of a request. Prior to MoCRA, there were no adverse event reporting obligations for cosmetics, though such requirements have been established for all drugs and dietary supplements but not for conventional foods.
- Labeling: In addition to the contact information described above, cosmetic product labels must identify each fragrance allergen in the cosmetic product as determined by FDA in a forthcoming regulation. The agency must publish a notice of proposed rulemaking (NPRM) for these fragrance allergens within 18 months of enactment of MoCRA, and a final rule must be issued within 180 days of the close of the comment period of the NPRM. In addition, cosmetic products intended only for professional use (i.e., by individuals licensed by a state authority to practice in cosmetology, nail care, barbering or esthetics) must be indicated as such clearly and prominently on the label. Prior to MoCRA, cosmetic labels were subject to prohibitions against false and misleading labeling and other, more general labeling requirements.
- Mandatory recall authority: Under MoCRA, FDA now has the authority to initiate a mandatory recall of a cosmetic product—after providing the responsible person with the opportunity to implement a voluntary recall—if it determines there is a reasonable probability that the product is adulterated or misbranded and will cause serious adverse health consequences or death. Prior to MoCRA, the agency did not have mandatory recall authority for cosmetics. Congress has provided FDA with such authority for conventional foods and dietary supplements but not for drugs.
For companies manufacturing and marketing cosmetic products in the U.S., the time to prepare to meet these new requirements is now. Cosmetic companies that have well-established, well-documented procedures for responsible facility operations, manufacturing and product safety are in a good position to comply with the new requirements, most of which will take effect on Dec. 29, 2023.
Even so, the American Herbal Products Association (AHPA) does have some concern about the potential impact of these requirements on cosmetic products containing herbal ingredients, especially those produced by smaller companies. For instance, the safety substantiation requirement may prove particularly burdensome.
The “adequate substantiation of safety” that will be required of both ingredients and finished cosmetic products before coming to market must come in the form of “tests or studies, research, analyses, or other evidence or information…sufficient to support a reasonable certainty that a cosmetic product is safe,” meaning a cosmetic product or ingredient “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.”
This requirement effectively calls for cosmetic manufacturers to prove a negative—that is, provide sufficient support that each finished cosmetic product and ingredient does not cause harm and is, therefore, safe for use by consumers. Such safety testing and research may drive smaller companies with more limited resources out of the cosmetic sector or out of business altogether. Another potential challenge is FDA is not required to issue any regulations related to the safety requirement before it goes into effect at the end of 2023.
No stranger to similar regulatory requirements that already govern dietary supplements, AHPA is actively evaluating these new cosmetics requirements and their potential impact on cosmetic products containing herbal ingredients to develop resources that will assist companies in this space with compliance. As with all regulatory matters impacting our members and the wider community, we are here to provide support and guidance to ensure safe, high-quality herbal and natural products—including cosmetics—remain accessible to consumers.
Michael McGuffin has served as president of the American Herbal Products Association since 1999, leading the association in its mission to promote the responsible and sustainable commerce of herbal products to ensure that consumers have informed access to a wide variety of safe herbal goods. McGuffin also serves on the boards of directors of the American Herbal Pharmacopoeia and United Plant Savers, and on the advisory boards of the USC School of Pharmacy regulatory science master's degree program and the Appalachian Beginning Forest Farmers Coalition. An industry veteran, McGuffin has been active in the herbal community since 1974, and he has taken the lead on legislative matters and regulatory advocacy that have shaped the herbal and natural products industry over the last several decades.
President, American Herbal Products Association (AHPA)
Michael McGuffin has served as president of the American Herbal Products Association (AHPA) since 1999, leading the association in its mission to promote the responsible and sustainable commerce of herbal products to ensure that consumers have informed access to a wide variety of safe herbal goods. McGuffin also serves on the boards of directors of the American Herbal Pharmacopoeia (AHP) and United Plant Savers, and on the advisory boards of the USC School of Pharmacy regulatory science master's degree program and the Appalachian Beginning Forest Farmers Coalition.
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