New Cosmetics Regulatory Scheme to Reshape Industry's Relationship with FDA
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) went into effect with US President Joe Biden’s signing of the Consolidated Appropriations Act, 2023. This legislation will profoundly change the way cosmetic companies interact with the US Food & Drug Administration (FDA). Before MoCRA was signed into law, there had been no major updates to the FDA’s regulation of cosmetics in nearly 50 years and only limited oversight of these products. As the FDA begins its rulemaking process, the cosmetic industry should actively participate in the development of regulations to ensure that they reflect practical considerations and reasonable requirements. Stakeholders should also raise specific issues during the rulemaking process to allow the FDA to clarify any potential confusion involving the regulations.
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Under MoCRA, cosmetic companies are required to register, list products, comply with good manufacturing practices (GMPs), develop safety data, include a domestic address and contact information on the product label, label allergens, include a professional use label for applicable products, maintain records and report adverse events.
Although there are many aspects of MoCRA that should be considered, manufacturers should keep in mind, for example, that the definition of a “serious adverse event” for combination over-the-counter drug and cosmetic products (e.g., tinted moisturizers with sunscreen) under MoCRA differs from the definition for nonprescription drugs:
“Serious adverse event” for nonprescription drugs is defined as “an adverse event that (A) results in (1) death; (2) a life-threatening experience; (3) inpatient hospitalization; (4) a persistent or significant disability or incapacity; or (5) a congenital anomaly or birth defect; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).” (See 21 U.S.C.A. § 379aa.)
“Serious adverse event” for cosmetic products is defined as “an adverse event that (A) results in (1) death; (2) a life-threatening experience; (3) inpatient hospitalization; (4) a persistent or significant disability or incapacity; (5) a congenital anomaly or birth defect; (6) an infection; or (7) 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; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A).” (See MoCRA.)
MoCRA also granted the FDA greater authority to enforce against cosmetic companies. The FDA may inspect facilities, access certain records, request voluntary recalls and order mandatory recalls. If there is reasonable probability that a product will cause serious adverse health consequences or death to humans, MoCRA allows the FDA to suspend a facility’s registration, an action that may be combined with other already existing enforcement tools.
These new regulatory requirements will significantly change the cosmetic industry’s relationship with the FDA, as interactions and oversight will drastically increase.
The regulatory landscape is seismically shifting for the cosmetic industry. As the FDA engages stakeholders and initiates rulemaking, companies should consider engaging in the process to ensure that regulatory requirements accurately reflect current practices and consumers’ use of cosmetic products. With quickly approaching deadlines, the FDA must develop infrastructure to allow companies to comply with registration and product listing, as well as more complex requirements such as adverse event reporting and GMPs.
As an initial first step, companies should consider an internal assessment of existing products and compliance with the proposed requirements under MoCRA. The first MoCRA-related deadline is December 2023, when companies must register their facilities, include professional use labels where applicable, and submit a cosmetic product listing and adverse event reporting to the FDA. Although registration and listing will be primarily administerial, companies should develop standard operating procedures to manage the process, as well as monitor adverse events and report serious ones by qualified individuals. Companies should also be prepared to address additional MoCRA-required activities, such as identification of allergens, allergen labeling and GMPs, as the FDA engages in rulemaking on those issues.