By: Daniel R. Dwyer and Vanessa K. Fulton
**1/10/24 Update: FDA has now published a final guidance detailing recommendations and instructions for complying with the registration and listing requirements. This final guidance states FDA’s intent to delay enforcement of the registration and listing requirements for 6 months, until July 1, 2024. See our KKB Blog Post, “Cosmetic Registration and Listing – It’s Around the Corner and Details Come into View” for additional information.
On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023, which includes the Modernization of Cosmetics Regulation Act of 2022. This is the first update of cosmetics regulation in the United States since 1938. The following provides a summary of the new rules, and our commentary:
DEFINITIONS
Among other things, the new law defines “cosmetic product” as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.” It does not alter the existing definition of “cosmetic” in 21 USC 321(i), which covers –
(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.
As such, the new definition creates a subset of “cosmetics” that consist of two or more ingredients “for use in a finished product.”
COMMENT: This definition appears to be intended to cover in-process cosmetic materials and bulk materials, as well as cosmetic products in finished packaging – so that future GMP regulations will apply to all of these “cosmetic products” but not (necessarily) the individual ingredients from which those products are made.
ADVERSE EVENT REPORTING
- Serious adverse event reports must be submitted by a “Responsible Person,” that is, the manufacturer, packer or distributor whose name appears on the label.
- Reports are required within 15 business days, together with a copy of the product label. New medical information received within one year is required to be submitted within 15 business days.
COMMENT: These new rules are similar to those for dietary supplements and OTC drugs, but with some interesting variations in the definition of “serious adverse event,” as below …
- “Serious” refers to:
- Death
- Life-threatening experience
- Inpatient hospitalization
- Persistent or significant disability or incapacity
- Congenital anomaly or birth defect
- Infection
- Significant disfigurement (e.g., serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), under conditions of use that are customary or usual
- Medical intervention needed to prevent the above outcomes.
COMMENT: This definition of “serious” includes some effects that are not defined as “serious” for dietary supplements and OTC drugs, such as “infection” and “significant disfigurement.” These are rather vague categories that could result in many reports that likely would not have been reported as serious adverse events in the past (for example, when reporting voluntarily under the PCPC Consumer Commitment Code). The word “infection” was added to the most recent version of the Bill; it appears to cover any infection, whether major or minor. The inclusion of “significant disfigurement” may reflect, among other things, concerns expressed by FDA and consumer plaintiffs about hair loss, balding, itching, rash or other reactions as a result of use of certain cosmetic products for hair.
- Records are required to be maintained, in general, for 6 years (or 3 years for small businesses) and are subject to FDA inspection.
- Fragrance and flavor ingredients that contribute to reported serious adverse events must be disclosed to FDA upon request. Such information is protected from public disclosure.
- The effective date for the above provisions is December 29, 2023.[1]
LABELING
- Cosmetic product labels are required to bear a domestic address, phone number or electronic contact information through which consumers can submit adverse event reports. Effective date: December 29, 2024.
- Cosmetic product labels are required to declare the names of fragrance allergens. This will take effect when FDA determines by regulation the ingredients that are fragrance allergens. FDA must publish a proposed rule by June 29, 2024, and a final rule within 180 days of the close of the comment period.
- “Professional” use of a cosmetic is defined as use by a licensed individual (e.g., in cosmetology, esthetics, nail care or barbering). Professional use products must be labeled for use only by licensed professionals. Effective date: December 29, 2023.[2]
GOOD MANUFACTURING PRACTICE (GMP)
- FDA must promulgate cosmetic GMP regulations consistent with national and international standards. A proposed regulation is required by December 29, 2024 and a final rule is required by Dec. 29, 2025. Such regulations may permit FDA to inspect records necessary to demonstrate compliance.
COMMENT: Over the long term, this provision will be the most significant change to cosmetics regulation, as it will give FDA the authority to enforce manufacturing standards through records-based inspections – similar to its authority for all other products it regulates.
REGISTRATION AND LISTING
- Facilities that currently manufacture or process cosmetic products for distribution in the United States must register with FDA by December 29, 2023. New facilities must register within 60 days of first engaging in manufacture or processing (or by 60 days after December 29, 2023, if later). Updates must be submitted within 60 days of any change. Registrations must be renewed biennially. The exact timing and content of submission of registration information will be prescribed by FDA.
- Foreign facilities will require a US agent.
- Product listings must be submitted, for existing products by December 29, 2023, or for new products within 120 days of marketing. Updates are due annually. Listing information must include the ingredient list for the product (using the name required by regulation).
- FDA will assign a facility number for each facility and a product listing number for each product. These numbers are confidential.
COMMENT: These rules are similar to the current requirements for facility registration and product listing that apply to drugs.
- FDA may suspend a facility registration if it determines that a cosmetic product manufactured or processed by the facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans and FDA has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility.
COMMENT: This new authority is similar to FDA’s authority to suspend food facility registrations. It has been rarely used for food facilities but, when used, it provides a powerful and relatively efficient tool for dealing with products that present a significant threat to the public health. Cosmetics manufacturers can expect that FDA may use this process if insanitary manufacturing conditions are not voluntarily remediated.
SAFETY SUBSTANTIATION
The Responsible Person must maintain adequate substantiation of safety, consisting of evidence considered by qualified experts to support a reasonable certainty that the product (including any ingredient in the product) is not injurious to users under labeled conditions of use, or under customary or usual conditions of use (not including minor or transient reactions). Coal-tar hair dyes are excepted if they comply with the statutory warning for such products, but records relating to safety must be maintained. Effective date: December 29, 2023.[3]
COMMENT: This supersedes 21 CFR 740.10, which since 1975 has required a cosmetic product to be adequately substantiated for safety unless it is labeled, “Warning – The safety of this product has not been determined.”
RECORDS INSPECTION
If FDA has a reasonable belief that a cosmetic product or ingredient is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans, it may, with written notice, inspect any records relating to such cosmetic product and any other cosmetic product that FDA believes is similarly affected. The scope of the records inspection is broad, extending to any record needed to assist FDA in determining whether the cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans. However, this authority does not extend to recipes, formulas, financial data, pricing data, personnel data, research data (other than safety substantiation data), and sales data (other than shipment data). This authority appears to be immediately effective.
COMMENT: This records inspection authority is similar to that which FDA has for foods. This authority has so far been rarely used with food facilities – but it is, like the registration suspension authority discussed above, a powerful tool for dealing with products that present a significant threat to the public health.
RECALL AUTHORITY
If FDA determines that there is a reasonable probability that a cosmetic is adulterated
or misbranded, and the use of or exposure to such cosmetic will cause serious adverse health consequences or death, it must provide the manufacturer, packer or distributor whose name appears on the label with an opportunity to voluntarily cease distribution and recall the product. If this is not done, then FDA may order distribution to cease and, after a hearing, may order a recall. Effective Date: December 29, 2023.[4]
COMMENT: This mandatory recall authority is similar to that which FDA has for foods. As a practical matter, almost all recalls are undertaken voluntarily, either on a company’s own initiative or in response to an FDA request. FDA has a very convincing way of asking for voluntary recalls even without mandatory recall authority, because it can threaten to issue a public health advisory or other publicity under 21 USC 375 if a company does not agree to conduct a voluntary recall. However, mandatory recall authority can be a useful tool for FDA in unusual circumstances.
SMALL BUSINESS
The new law includes certain exceptions for small businesses, which are defined as those whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000 (adjusted for inflation).
Specifically, small businesses may be exempt from the GMP and registration and listing requirements, provided they do not engage in manufacturing or processing any of the following cosmetic products: those that regularly come into contact with the mucus membrane of the eye, injected cosmetics, cosmetics intended for internal use, or cosmetic products intended to alter appearance for more than 24 hours under usual conditions and are not usually removed by the consumer.
COSMETICS THAT ARE ALSO DRUGS
Cosmetics that are also drugs are exempt from the cosmetics provisions in the new law, except for requirements governing labeling of fragrance allergens and professional labeling.
COMMENT: There are a number of OTC drugs that also have cosmetic benefits, such as antiperspirants with deodorant fragrances, or skin protectant lip balms with flavor and fragrance. These will be subject to labeling requirements for fragrance allergens.
PREEMPTION
The law prohibits states from establishing a law that is different from or in addition to, or otherwise not identical with, any requirement with respect to registration and product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation. Preemption is expressly limited to these provisions and does not extend to other state laws, including laws prohibiting or limiting ingredients, or requiring the reporting of ingredients.
COMMENT: This preemption provision will likely not preempt state laws (and consumer class-action lawsuits based on such laws) that require labeling (such as California’s Proposition 65 and various state hemp laws), that prohibit ingredients such as PFAS, or that require reporting of certain ingredients.
SPECIFIC INGREDIENTS
FDA is required to publish proposed regulations providing standardized test methods for detecting asbestos in talc-containing cosmetic products by December 29, 2023, and a final rule within 180 days of the close of the comment period. FDA is also required to assess the safety of PFAS in cosmetic products and publish a report by December 29, 2025.
FUNDING
FDA’s funding for cosmetic regulation is authorized to triple over three years, from $14 million in FY2023 to $42 million in FY2025.
COMMENT: This increase in funding is significant for purposes of undertaking the newly required regulatory programs – but even $42 million is a small amount compared to FDA’s regulatory programs for foods and drugs. It remains to be seen whether Congress will fully fund FDA’s oversight of cosmetics in the future.
CONCLUSION
KKB attorneys are available to assist and advise on these issues and will continue to monitor for any FDA rulemaking pursuant to this new law.
[1] The effective date of December 29, 2023, reflects the date on which FDA has the authority to enforce these provisions. See MoCRA Section 3503(a)(4); (b)(1).
[2] The effective date of December 29, 2023, reflects the date on which FDA has the authority to enforce these provisions. See MoCRA Section 3503(a)(3); (b)(1)
[3] The effective date of December 29, 2023, reflects the date on which FDA has the authority to enforce these provisions. See MoCRA Section 3503(a)(2); (b)(1).
[4] The effective date of December 29, 2023, reflects the date on which FDA has the authority to enforce these provisions. See MoCRA Section 3503(a)(1); (b)(1).