New Requirements for Cosmetics Importers Going into Effect

On Dec 29, 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was enacted as part of the Omnibus Appropriations Act of 2022 passed by the US Congress on Dec 29, 2022. The intent behind MoCRA is to strengthen the US Food & Drug Administration (FDA) authority over cosmetic products. MoCRA represents the most significant expansion of FDA’s authority over cosmetics since the original enactment of the Food & Drug Cosmetic Act of 1938 (FD&C Act). While most of MoCRA was scheduled to go into effect within one year (i.e., by Dec 29, 2023), a few of the items will be phased in over the next three years.

While MoCRA does not specifically state any requirements for importers, it is valuable to understand the requirements as future modifications to the legislation may cover importers and the importation of cosmetic products.

MoCRA covers the following nine areas:

1. Introduction of a facility registration and a product listing
2. Introduction and amendments to definitions. This includes “cosmetic product,” “responsible person,” “facility,” “adverse event,” and “serious adverse event.”
3. Introduction of good manufacturing practices (GMP) for facilities
4. Introduction of safety substantiation for cosmetic products, including record retention
5. The addition of serious adverse event submissions
6. Expansion of labeling requirements
7. Expansion on enforcement, mandatory recalls, recordkeeping, and record inspection
8. New ingredient-specific requirements for talc-containing cosmetic products; and
9. New requirements to assess the use, safety, and risks of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products.

Facility registration and product listing

The most immediate impact of MoCRA is the implementation of the Cosmetics Facility Registration and product listing as FDA ended the voluntary cosmetics registration program in March 2023.

Under MoCRA, each manufacturing facility for cosmetic products must maintain a valid facility registration with FDA. Like the Food Facility Registration, there is also a requirement for biennial renewal. FDA has published draft guidance on this procedure as they have created a new portal for this process (CDER Direct), but it is currently unavailable.

Additionally, to use CDER Direct, the facilities must have an FDA Establishment Number (FEI). FDA has created the FDA Office of Regulatory Affairs (ORA) Unified Logon Portal which was deployed into production on Wednesday, Nov 29, 2023. The portal provides access to four modules:

1. FEI Portal – Allows a user to look up an FEI based on a firm name and address or validate an address of an FEI.
2. Enforcement Reports API – Retrieves recall information using the various REST Endpoints for the Enforcement Reports application, called iRES (internet Recall Enterprise System).
3. Product Code Builder API – The Product Code Builder (PCB) API retrieves the FDA product code information based upon the code portions selected for each of the five components (Industry, Class, Subclass, PIC, and Group) using the various REST Endpoints.
4. Enforcement Reports Subscription – This service allows users to subscribe, manage subscriptions, and receive e-mail when there are new or updated recalls in the Enforcement Reports application.

While the Act states an existing facility currently in operation must register by Dec 29, 2023, FDA has announced a delay in the enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information.

The Act also states that new facilities must register within 60 days of first engaging in the manufacturing or processing of a cosmetic product for distribution in the US. For contract manufacturers, MoCRA clarifies that either the facility or any responsible person whose products are manufactured or processed at such facility may submit the registration for that facility.

In addition to the cosmetic facility registration, responsible persons must also maintain listings of their cosmetic products with FDA, including each product’s name, type, ingredients (including fragrances, flavors, or colors), and facility of manufacture or processing. The responsible person must submit their product listing for currently marketed products the newly updated date, and for any new cosmetic product within 120 days of marketing such product.

Registration must occur on a per-facility basis whereas listing must occur on a per-responsible person basis. Further, the processes are to operate on separate timelines, with registration renewals occurring every two years and listing updates occurring every year.

A responsible person, as defined by MoCRA, is “the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.”

A facility is any establishment that manufactures or processes cosmetics that are distributed in the United States. However, MoCRA specifically excludes establishments that “solely perform” labeling, relabeling, packaging, repackaging, holding, and/or distributing cosmetic products.

Are there any exemptions to the Facility Registration requirements?

Per FDA, MoCRA exempts certain small businesses from facility registration and product listing requirements. However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:

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

Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.

 

What are the other elements of MoCRA should I concern myself with?

Good Manufacturing Practices

The FD&C Act and FDA regulations did not historically contain GMP requirements for cosmetics. However, FDA has maintained that compliance with GMPs is important to minimize the risk of adulteration or misbranding of cosmetic products. Instead, FDA and industry have traditionally looked to the international standard for cosmetics GMPs under ISO 22716.

 

For the first time, MoCRA creates a legal requirement for manufacturing facilities to comply with FDA-issued GMPs. MoCRA directs the FDA to develop GMPs that:

• are consistent and appropriate with both national and international standards to ensure cosmetic products are not adulterated,
• consider the size and scope of the facilities, as well as the risks to public health posed by the cosmetics they manufacture; and,
• are informed by cosmetic manufacturers (including smaller businesses), consumer organizations, and selected experts.

 

FDA must issue a proposed rule for these GMP regulations by Dec 29, 2024, and a final rule no later than Dec 29, 2025. The proposed GMP requirements should align with appropriate national and international standards and are meant to “…ensure that cosmetic products are not adulterated.” GMP will also result in records that will provide insight for inspectors to demonstrate compliance.

It is anticipated that the GMP regulations to be issued by FDA will follow a framework like ISO 22716 given that:

• FDA has previously recommended that manufacturers adopt requirements of ISO 22716 in guidance,
• industry has voluntarily adopted compliance with ISO 22716,
• the Agency recognizes the importance of international harmonization of regulatory requirements; and,
• Congress’s direction to FDA to develop GMPs that are consistent with international standards.

 

Safety Substantiation and Recordkeeping

MoCRA requires safety substantiation for cosmetic products. Responsible persons must ensure that their cosmetic products are safe and must maintain records of adequate substantiation of safety for each.

Key terms mentioned in this section include:

FDA defines Safe to mean “…that the 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.”

Additionally, Adequate substantiation per FDA means “…tests, studies, research, analyses, or other data considered by experts qualified by scientific training and experience as sufficient to support that the product and its ingredients are “safe” (i.e., are not injurious when used in accordance with the labeling or customary use).

Cosmetic products that do not have adequate safety substantiation will be considered adulterated under section 601 of the FD&C Act.

Per FDA considers a product Adulterated:

• If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual, except that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon:

“Caution—This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.,” and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term “hair dye” shall not include eyelash dyes or eyebrow dyes.”

• If it consists in whole or in part of any filthy, putrid, or decomposed substance.
• If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
• If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.
• If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 379e(a) of this title.

The requirement is assumed to be enacted within one year as it is not stipulated otherwise.

 

Adverse Event Reporting and Recordkeeping

MoCRA requires cosmetic companies to report serious adverse events for the first time within specified time limits. Within fifteen (15) business days of receiving relevant information, a responsible person must report to FDA:

• any known serious adverse event (SAE) associated with the use of its cosmetic product(s) in the US. An SAE is 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 (such as serious rashes, second- or third-degree burns, significant hair loss, or alternation of appearance), or medical or surgical intervention to prevent such outcomes. And,
• any new and material medical information related to such SAE report that is received within one year after filing the initial report.

Responsible persons must receive, maintain, and make accessible for FDA inspection reports of adverse events associated with use of its cosmetic product(s) in the United States. Records related to adverse events must be maintained for six (6) years. This requirement is like the recordkeeping requirements for dietary supplements and over the counter (OTC) drugs.

If FDA has a reasonable belief that an ingredient or combination of ingredients in a fragrance or flavor has caused or contributed to an SAE and requests a list of the ingredients or categories of ingredients in that fragrance or flavor, then the responsible person must submit the requested information to FDA within 30 days of the request.

The requirement is assumed to be enacted within one year as it is not stipulated otherwise.

 

Labeling

FDA regulations currently require cosmetic products to be labeled with a listing of ingredients, statement of identity, net quantity of contents, and name and place of business of manufacturer, packer, or distributor (i.e., the principal place of business or the actual place where the cosmetic was manufactured, packed, or is to be distributed).

MoCRA expands this list by requiring the responsible person to identify on each product label:

• its domestic address, phone number, or electronic contact information through which it may receive adverse event reports. This requirement is to take effect two years after the date of enactment.
• if intended for “professional use” by a licensed professional cosmetologist, nail technician, barber, or esthetician, a clear and prominent statement that the product shall be administered or used only by licensed professionals. This requirement is to take effect one year after the date of enactment; and,
• any “fragrance allergens” included in the cosmetic product. Products that fail to include fragrance allergen disclosure will be considered misbranded. This requirement is to take effect no later than two years after the date of enactment and the issuance of a fragrance allergen rule.

 

Enforcement, mandatory recalls, recordkeeping, and record inspection

MoCRA grants FDA the authority to suspend the registration of a facility if FDA:

• determines that the facility manufactures or processes a cosmetic product for distribution in the US that raises a reasonable probability of causing serious adverse health consequences or death; and
• has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because the failure is non-isolated or sufficiently pervasive.

Consequently, FDA will bar the facility from introducing or delivering for introduction into interstate commerce any cosmetic products in the US until FDA determines that the facility corrects the violative conditions, vacates the suspension, and reinstates the registration. An effect of this provision is to give FDA the ability to prevent distribution of domestically produced cosmetic products about which it has safety concerns. FDA already has similar enforcement powers over internationally produced cosmetic products under its ability to place foreign facilities on Import Alerts and prevent the importation of cosmetics if FDA has reason to believe the products are adulterated or misbranded.

 

Further, under MoCRA, FDA may order a responsible person to cease distribution or recall a cosmetic product if:

• FDA determines there is a reasonable probability the cosmetic product is adulterated or misbranded and the use of or exposure to such product will cause serious adverse health consequences or death; and
• given the opportunity, the responsible person refuses to voluntarily recall or cease distribution of such product in accordance with the time and manner prescribed by FDA (if any).

 

FDA will itself notify the public that it has initiated a mandatory recall and may correspondingly order the responsible person to notify the public and affected persons (including persons who manufacture, distribute, import, or offer for sale the product).

 

Talc, PFAs and animal testing

MoCRA instructs FDA to issue regulations that establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetics. FDA has until Dec 29, 2023, to issue a proposed rule and then 180 days after the end of the public comment period to issue a final rule.

MoCRA also directed FDA to assess the use and safety of Per- and polyfluoroalkyl substances (PFAs) in cosmetic products, including any risks, and to publicly publish its findings by Dec 29, 2025. FDA published their research findings of PFAs in foods in May 2023 but continue their research on cosmetic products.

PFAs are synthetic chemicals widely used or added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara. PFAs may also be present in cosmetics unintentionally as the result of raw material impurities or due to the breakdown of PFAs ingredients that form other types of PFAs. PFAs are used to condition and smooth the skin, making it appear shiny, or for product consistency and texture.

Absent from its requirements are provisions that regulate the use of animal testing in cosmetics. Rather, MoCRA includes a “sense of Congress” statement, a formal opinion without teeth, which recommends animal testing not be used for purposes of safety testing of cosmetics and should be phased out. The industry had advocated for inclusion of the Humane Cosmetics Act (S. 3357) in MoCRA

Cosmetic companies should begin to review MoCRA’s requirements related to product safety substantiation, CGMP compliance, adverse events reporting, recordkeeping, and labeling. Since the FDA is scheduled to initiate rulemaking on these key areas of compliance, cosmetic companies should expect more guidance and specific regulations in the coming years. 

Cosmetic companies should take the time now to review their products, policies, and procedures to ensure compliance with MoCRA and responsiveness to the additional regulations that the FDA will be implementing.

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