Congress Passes Landmark Cosmetics Regulation in First Cosmetics Regulatory Change to FDCA Since 1938

On December 23, 2022, Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) as part of the year-end Consolidated Appropriations Act, of 2023. When signed into law shortly thereafter on December 29 by President Biden, MoCRA became the first statutory change to FDA’s authorities over cosmetics since the passage of the Food, Drug, and Cosmetic Act (FDCA) in 1938.

First discussed here, MoCRA amendments to the FDCA create federal standards for cosmetic product registration, product listing, good manufacturing practice, recordkeeping, recalls, adverse event reporting, and safety substantiation. “Cosmetic products” are specifically defined under MoCRA to mean the preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.

The new law establishes a similar process to those of other FDA-regulated products to ensure that cosmetic manufacturers provide assurances that their cosmetic products are safe and not adulterated. MoCRA establishes obligations for the “responsible person” – the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in section 609(a) of MoCRA or section 4(a) of the Fair Packaging and Labeling Act. Typically, this is the entity listed in the name and place of business statement on current cosmetic product labels. Importantly, the new requirements outlined in MoCRA do not take effect immediately. Rather, MoCRA includes specific compliance dates for certain requirements and directs FDA to undertake rulemaking or issue guidance to implement other requirements.

Regulatory Requirements for Cosmetics

FDCA Section 605: Adverse Event Recordkeeping and Serious Adverse Event Reporting

The newly added section 605 imposes new requirements on responsible persons pertaining to adverse events and significant adverse events for cosmetic products. The term “adverse event” is defined under MoCRA to mean any health-related event associated with the use of a cosmetic product that is adverse.  “Serious adverse event” is defined as an adverse event that –

• Results in
  • Death
  • A life-threatening experience
  • Inpatient hospitalization
  • A persistent or significant disability or incapacity
  • A congenital anomaly or birth defect
  • An infection
  • 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
• Requires, based on reasonable medical judgment, medical or surgical intervention to prevent an outcome described above.

Although these definitions are like the existing framework for dietary supplements and OTC drugs, the scope of both adverse events and serious adverse events is broadened and tailored to account for the particulars of cosmetic products.

Under the new requirements, a responsible person must (1) maintain records of any health-related adverse events associated with the use of its cosmetic product for six years (or three years for small businesses that meet certain exception thresholds) and (2) report to FDA any serious adverse events no later than 15 days after learning of the such event. The serious adverse event report may include a statement released to the public (without any personal health information). Additionally, for a one-year period following the initial submission, responsible persons are required to report to FDA any new and material medical information it learns of related to a serious adverse event within 15 days of learning of such new information. Submissions shall not be construed as an admission that the cosmetic product involved, caused, or contributed to the relevant adverse event.

If the Department of Health and Human Services (HHS) Secretary has reason to believe that a specific ingredient or combination of ingredients in a fragrance or flavor has caused or contributed to a serious adverse event, the Secretary may request in writing a list of such ingredient(s) or flavor(s). In such instances, the responsible person must submit the list of ingredient(s) or flavor(s) within thirty days of such request.

Moreover, the responsible person shall permit an officer or employee of HHS (with requisite credentials) to have access to inspect records, manufacturing, and other issues.

FDCA Section 606: Good Manufacturing Practice (GMP)

Section 606 directs that the Secretary of HHS shall also establish good manufacturing practices (GMP) for facilities via regulation. Such GMP regulations should be consistent with both national and international standards and be designed to protect public health and ensure that cosmetic products are not adulterated. The regulations may also allow for the Secretary to inspect records necessary to demonstrate compliance with GMP. If a cosmetic product has been manufactured or processed under conditions that do not meet the regulations, the product will be deemed adulterated under section 601 of the FDCA.

The proposed rulemaking shall be no later than two years after the date of MoCRA enactment (December 29, 2024) and the final regulations shall be published no later than three years after MoCRA enactment (December 29, 2025).

FDCA Section 607: Registration and Product Listing

The introduced Section 607 mandates cosmetic facility registration and cosmetic product and ingredient listing with FDA. More precisely, MoCRA directs that every facility (whether domestic or foreign) that engages in the manufacturing or processing of a cosmetic product for distribution in the U.S. must register with FDA. The term “facility” under MoCRA includes numerous carveouts, including cosmetic product retailers; establishments that manufacture or process cosmetic products that are solely for use in research or evaluation; and establishments that solely perform labeling, relabeling, packaging, repackaging, holding, or distributing activities.

Existing facilities must submit a registration to FDA within one year of enactment of MoCRA (December 29, 2023). New facilities must register within sixty days of beginning to manufacture cosmetics or sixty days within the deadline for existing facilities, whichever is later. Facilities must also renew their registrations every two years.

Additionally, responsible persons must also list each cosmetic product, including ingredients and information about where the cosmetic product is manufactured, with FDA. The contents of the product listing must include the following:

• Facility registration number of each facility where the cosmetic product is manufactured or processed
• Name and contact number of the responsible person and the name of the cosmetic product (as it appears on the label)
• Applicable cosmetic categories or categories for the cosmetic product
• List of ingredients in the cosmetic product, by name as required in the CFR as well as the common or usual name, including:
  • Fragrances
  • Flavors
  • Colors
• Product listing number (if previously assigned by the Secretary)

A responsible person must submit a product listing for a cosmetic product marketed prior to the enactment of MoCRA within a year of its enactment (December 29, 2023); a responsible person must submit product listings for products first marketed after the enactment within 120 days of marketing. All product listings must be updated annually. A single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations or formulations that differ only with respect to colors, fragrances, flavors, or quantity of contents.

FDCA Section 608: Safety Substantiation

Section 608 addresses new safety substantiation requirements for responsible persons and cosmetic products. Specifically, a responsible person “shall ensure, and maintain records supporting, that there is adequate substantiation of the safety of the such cosmetic product.” “Adequate substantiation of safety” is defined to mean 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 a reasonable certainty that a cosmetic product is safe.

Under MoCRA, “safe” means that a cosmetic product, including any ingredient thereof, 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. Importantly, a cosmetic product or cosmetic ingredient will not be considered injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. This is critical because many adverse events individuals experience from cosmetics are due to minor idiosyncratic reactions or particular hypersensitivities or aversions.

FDCA Section 609: Cosmetic Labeling and Fragrance Allergen Transparency

Under new section 609, each cosmetic product must include a label that specifies a domestic address, domestic phone number, or electronic contact information through which the responsible person can receive adverse event reports for the respective cosmetic product. In addition, the following apply to the labeling of cosmetic products.

• Fragrance Allergens: The responsible person shall identify on the label each fragrance allergen included. Substances that are “fragrance allergens” for purpose of this labeling requirement shall be determined by the Secretary of HHS by regulation. The Secretary shall issue a notice of the proposed rule on June 29, 2024 (18 months after the date of MoCRA enactment) and a final rule 180 days after the public comment period closes. In drafting the implementing regulations, the Secretary shall consider international, state, and local requirements for allergen disclosure, including the substance of the format of requirements for the European Union. Additionally, the Secretary may establish threshold levels of amounts to warrant disclosure.

• Cosmetic Products for Professional Use: A “professional” is an individual who is licensed by an official state authority to practice in the field of cosmetology, nail care, barbering, or esthetics.

• Professional Use Labeling: A cosmetic product intended to be used only by a professional must include a label that contains a clear and prominent statement that the product shall be administered or used only by licensed professionals, and must otherwise conform to the labeling requirements for cosmetic products.

FDA Enforcement Authorities

FDCA Section 607: Facility Suspension

MoCRA grants FDA the authority to suspend the registration of a facility if it determines that a cosmetic product manufactured has a reasonable probability of causing serious adverse health consequences or death and the Secretary has a reasonable belief that other products manufactured by the facility may be similarly affected, either because of a failure that cannot be isolated to a product or products or is sufficiently pervasive to raise concerns about other products manufactured at such facility. Once a facility is suspended, no person shall introduce or deliver for introduction into commerce in the U.S. a cosmetic product from the offending facility.

Prior to suspension, the Secretary must provide notice to the facility of the intent to suspend and the basis for suspension. Upon notice, the responsible person will have five business days to provide a plan to address the reasons for possible suspension. Additionally, Section 607 provides an opportunity for an informal hearing to be held no later than five days after the suspension order. The Secretary may conclude that the suspension remains necessary, or the registrant may be required to submit a corrective action plan to remediate the underlying issues. The plan must be reviewed within fourteen days after submission of the plan. If the Secretary vacates the suspension, the facility will be reinstated.

Notably, the Secretary may not delegate the authorities under Section 607 other than to the Commissioner of the FDA.

FDCA Section 610: Records

Under new Section 610, FDA is afforded the authority to access and inspect records relating to a cosmetic product if the Secretary of HHS reasonably believes that a cosmetic product or cosmetic ingredient is adulterated and presents a threat of serious adverse health consequences. However, this authority does not extend to recipes or formulas for cosmetics; financial data; pricing data; personnel data; research data (other than safety substantiation data under MoCRA); and sales data (other than shipment data regarding sales).

Notably, nothing in Section 607 shall be construed to limit the Secretary’s ability to inspect records or require the establishment and maintenance of records under any other provision of the law.  

FDCA Section 611: Mandatory Recall Authority

If the Secretary determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and the use or exposure will cause serious adverse health consequences or death, the Secretary shall provide the responsible person with an opportunity to voluntarily cease distribution and recall the cosmetic product. If the responsible person refused to do so or does not voluntarily cease distribution or recall, the Secretary may, by order, require the responsible person to immediately cease distribution of the cosmetic product.

An informal hearing may be held no later than ten days after the issuance to determine whether adequate evidence is present to justify the recall order. Section 611 provides a resolution process to either recall the product or permit the product to continue distribution. The Secretary may require notice from affected individuals. Additionally, a press release must be published and alerts and public notices to the public issue, as appropriate, in the event of a recall. The public notification should include at a minimum:

• Name of the cosmetic product subject of the recall
• Description of the risk associated
• Information for consumers about similar cosmetics not affected by the recall (to the extent practicable)
• An image of the cosmetic that is the subject of the recall on the FDA website

Section 611 does not affect the authority of the Secretary to request or participate in a voluntary recall or to issue an order to cease distribution or to recall under any other provision.

Other Notable Provisions

FDCA Section 612: Small Businesses

MoCRA provides certain accommodations for small businesses. Specifically, responsible persons and owners and operators of facilities whose gross annual sales in the U.S. of cosmetic products for the previous three-year period is less than $1,000,000 (adjusted for inflation) shall be considered a “small business” and not subject to the requirements under Section 606 (GMP) or Section 607 (registration and product listing). And as noted above, under Section 605 “small businesses” must only maintain records of adverse health events associated with the use of a cosmetic product for three years (as opposed to six years).

Critically, the small business exceptions do not apply to responsible persons or facilities engaged in the manufacturing or processing of any of the following:

• Cosmetic products that regularly come into contact with the mucus membrane of the eye under conditions of use that are customary or usual
• Cosmetic products that are injected
• Cosmetic products that are intended for internal use
• Cosmetic products that are intended to alter the appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual

FDCA Section 613: Exemption for Certain Products and Facilities

Section 613 provides key exemptions for products regulated as both drugs and cosmetics under FDCA. Specifically, a cosmetic product or facility that is subject to Chapter V of the FDCA is exempt from the new MoCRA requirements relating to adverse event reporting, GMPs, facility registration and product ingredient listing, safety substantiation, and contact information labeling, and FDA’s records access and mandatory recall authority. However, such products must still comply with the new fragrance allergen and professional use labeling requirements.

FDCA Section 614: Preemption

State and local governments are precluded under MoCRA from enacting, implementing, or enforcing requirements for cosmetics that are different from MOCRA’s requirements. Specifically, no state may establish or continue in effect any law, regulation, order, or another requirement for cosmetics that are different from or in addition to, or otherwise not identical with, any requirement applicable under MoCRA with respect to registration and product listing, GMP, records, recalls, adverse event reporting, or safety substantiation.

However, MoCRA does provide two exceptions – 1) states may prohibit the use of or limit the amount of an ingredient in cosmetic products under state law, and 2) states may continue to enforce reporting requirements such as California’s Proposition 65 that was in existence prior to MoCRA’s passage.

Notably, MoCRA does not provide federal preemption protections for state law failure to warn or personal injury claims. MoCRA includes a “savings clause” to specify that nothing in MoCRA shall be construed to modify, preempt, or displace any action for damages or the liability of any person under the law of any state, whether statutory or based on the common law.

MoCRA Section 3505: Talc-Containing Cosmetics

No later than one year after the enactment of MoCRA (December 29, 2023), the Secretary shall propose regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. The final regulations must be issued no later than 180 days after public comment period closes for the proposed rule.

MoCRA Section 3506: PFAS in Cosmetics

The Secretary of HHS is directed to assess the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products and the scientific evidence regarding their safety, including any risks associated with such use. In doing so, the Secretary of HHS may consult with the National Center for Toxicological Research. The Secretary must issue a report – via publication on the FDA website – summarizing the results of the assessment no later than three years after the enactment of MoCRA (December 29, 2025).

MoCRA Section 3507: Sense of the Congress on Animal Testing

MoCRA states that it is the “sense of the Congress that 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.”

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