First Major Overhaul of Cosmetics Regulation Since FDR Administration

As part of the Consolidated Appropriations Act, 2023, President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”). This is the first major reform of cosmetics regulation since the Federal Food, Drug, and Cosmetic Act (“FDCA”) became law in 1938.[1] MoCRA implements new compliance requirements on the cosmetics industry and also significantly expands the U.S. Food and Drug Administration’s (“FDA”) authority to oversee and regulate cosmetics.

New Obligations for Cosmetics Industry

MoCRA imposes the following new requirements on “responsible persons”[2] and “facilities.”[3] We note that certain of these regulatory requirements may differ for entities considered small businesses under MoCRA.

• Facility Registration and Product Disclosure. All facilitates (domestic or foreign) that manufacture or process cosmetic products for distribution in the United States must register with FDA by December 29, 2023. Registration is biennial. Further, responsible persons must annually submit cosmetic product listings to FDA and disclose key product information, such as ingredients.
• Adverse Event Recording and Serious Adverse Event Reporting. Generally, responsible persons must keep records of any adverse events related to products used in the United States for six years and submit any “serious adverse events” to FDA within 15 days of the responsible person’s receipt of the report. MoCRA broadly defines what constitutes a serious adverse event, when compared to other FDA regulatory product categories (e.g., dietary supplements).[4]
• Labeling Requirements. To improve the reporting of adverse events, responsible persons must include contact information on product labels. Additionally, product labels must identify any fragrance allergens in the product. Labels for products intended for use only by licensed professionals must also indicate that only licensed professionals may use the product.
• Safety Substantiation Requirement. Responsible persons must ensure that a product is “safe” and keep records “adequately substantiating” the product’s safety.[5] Products without adequate safety substantiation may be considered adulterated under the FDCA. MoCRA also contains a provision stating that it is the sense of Congress that animal testing should not be used for safety testing on cosmetic products and should be phased out with the exception of appropriate allowances.

Increased FDA Oversight of Cosmetics

MoCRA significantly expands FDA’s enforcement authority over the cosmetics industry.

• Issue Mandatory Recalls. FDA now has mandatory recall authority if the agency concludes there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of the cosmetic will cause serious adverse health consequences or death.
• Access Records. If FDA has a reasonable belief that a cosmetic product (or one of its ingredients) is adulterated and presents a threat of serious adverse health consequences or death, the agency has authority to access records relating to that product.
• Suspend Facilities. FDA may suspend a facility’s registration if the agency determines that a cosmetic product manufactured or processed by that facility has a reasonable probability of causing serious adverse health consequences or death and there is a reasonable belief that other products from the same facility may be similarly affected.
• Federal Preemption. MoCRA explicitly preempts any state or local laws that differ from the federal cosmetics framework regarding facility registration and product listing, good manufacturing practices (“GMPs”), records, recalls, adverse event reporting, or safety substantiation.

Forthcoming FDA Rulemakings and Reports

MoCRA directs FDA to promulgate rules regarding the following three issues. Importantly, the cosmetics industry will have opportunities to provide comment on the proposed rules.

• GMPs. FDA must establish GMP regulations consistent with national and international standards. Cosmetic products manufactured or processed under conditions that do not meet FDA’s forthcoming GMP regulations may be considered adulterated. The agency must issue a proposed rule by December 29, 2024 and a final rule by December 29, 2025.
• Fragrance Allergens. FDA must publish regulations to identify fragrance allergens. Cosmetic product labels that do not include fragrance allergen disclosures required by such regulations may be considered misbranded under the FDCA. The agency must issue a proposed rule by June 29, 2024 and a final rule no later than 180 days after the public comment period.
• Talc. FDA must issue regulations to establish required standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

In addition to the above rulemakings, FDA must issue a report within the next three years on the use of per- and polyfluoroalkyl substances (“PFAS”) in cosmetic products.

Footnotes

1. MoCRA amends Chapter VI of the FDCA.
2. A “responsible person” is defined as a manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of that product.
3. “Facilities” are defined as any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States. MoCRA specifically exempts from registration certain facilities, such as those that (i) only label, relabel, package, hold, or distribute cosmetics products; and (ii) manufacture or process products solely for use in research and evaluation.
4. “Serious adverse events” are defined as adverse events that result in (i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; (v) a congenital anomaly or birth defect; (vi) infection; or (vii) significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance); or that require – based on reasonable medical judgment – a medical or surgical intervention to prevent one of the outcomes described above.
5. “Safe” is defined as a cosmetic product (and its ingredients) that is not injurious to users under the labeling or customary/usual usage. A cosmetic product (or its ingredients) should not be considered injurious solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. Further, “adequate substantiation” of safety means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support the product’s safety to a reasonable certainty.