US FDA Modernization of Cosmetics Regulation Act
By: Jacqui Jenskey, Principal Regulatory Affairs Consultant, email
The Modernization of Cosmetics Regulation Act (MoCRA) is considered a major overhaul of the US Food and Drug Administration’s (FDA) current regulatory framework for cosmetics and includes many new provisions for cosmetic products. These provisions create significant new authorities and oversight for the US FDA. While MoCRA does not include a premarket approval requirement for cosmetics (such as Cosmetic Notifications in Canada), it does create many new and significant obligations for the cosmetics industry in the USA and Internationally. Make sure you are going to meet your obligations by reviewing this summary.
Each facility that manufactures or processes cosmetic products for US distribution, whether the facility is located in the US or abroad, must register with the FDA. Existing facilities must register by December 29, 2023, whereas any new facilities must register within 60 days after beginning to manufacture cosmetics, or 60 days after the deadline for existing facilities, whichever is later. All facility registrations must be renewed every 2 years. Facilities that only perform activities related to the labeling, relabeling, packaging, repackaging, holding, and/or distributing of cosmetic products will not need to register.
Product Listing and Labeling
“Responsible persons” (i.e., manufacturers, packers, or distributors of a cosmetic product whose name appears on the label) are required to list with the FDA each cosmetic product, including its ingredients and information about where the cosmetic product is manufactured. Responsible persons are required to update cosmetic product labels to include contact information through which the responsible person can receive adverse event reports (a US address, US phone number, or electronic contact information). Note that international companies MUST now have a US agent who is on the label and who manages the Adverse Event reporting. For products marketed prior to December 29, 2022, a responsible person must submit product listings no later than December 29, 2023. For products first marketed after enactment, a responsible person must submit product listings within 120 days of marketing. Responsible persons must update product listings annually. Note that, 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. Product labels have 2 years to comply with this mandate.
Additional Label Changes for Professional Cosmetic Products
MoCRA requires labels for professional cosmetics products to include the same information that is required of cosmetic products intended for sale to consumers and to state that only licensed professionals may use the product. This requirement takes effect one year after the date of enactment of MoCRA.
Mandatory Adverse Event Reporting
Responsible persons are obligated to submit reports of serious adverse events to the FDA no later than 15 days after receiving the report and maintain all records related to serious adverse events for a minimum of six years. MoCRA provides specific details on what constitutes a reportable event. Reportable events may include infections or “significant disfigurement” such as “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”.
Responsible persons will be required to maintain records supporting “adequate substantiation” that the cosmetic product is safe. Cosmetic products that do not have adequate safety substantiation will be considered adulterated under a newly created adulteration provision within the FDCA.
Current Good Manufacturing Practice for Cosmetics
As part of this Act, the FDA must issue mandatory good manufacturing practice (GMP) regulations for cosmetics that are consistent with national and international standards. As the FDA’s current draft guidance for cosmetic GMP leverages elements from ISO 22716, we anticipate that the FDA’s future cosmetic GMP regulations will do the same. The FDA must have proposed regulations published by December 29, 2024, with final regulations no later than December 29, 2025.
Mandatory Fragrance Allergen Labeling
MoCRA requires the FDA to determine by regulation, fragrance allergens that must be disclosed on a cosmetic’s label. The FDA must have proposed regulations published by June 29, 2024, with final regulations no later than 180 days after the public consultation period closes.
MoCRA grants the FDA the authority to order a mandatory recall of a cosmetic product if it determines that the cosmetic product is likely to cause serious adverse health consequences or death.
In addition, this mandatory recall authority will include:
- if products fail to comply with the new GMP (adulteration)
- do not meet the safety substantiation regulations (adulteration)
- if a cosmetic product label fails to include the required fragrance allergens and US contact information (misbranding)
The FDA’s enforcement authority under MoCRA also allows the agency to suspend the registration of a cosmetic facility if there is a determination that a product manufactured or processed by the facility has a reasonable probability of causing serious adverse health consequences or death, and there is a reasonable belief that other products manufactured by the facility may be similarly affected.
Overall, these provisions bring cosmetics regulation into greater alignment with other FDA-regulated products, particularly those such as dietary supplements and over-the-counter drugs that do not require premarket approval.
Responsible persons and owners and operators of facilities whose gross annual sales in the United States of cosmetic products for the previous three-year period is less than $1,000,000 shall be considered small businesses and not subject to GMP, registration, and listing requirements. Adverse event reports only need to be kept for 3 years instead of 6 years for small businesses.
Proposed regulations must be completed by December 29, 2023, and finalized 180 days after the comment period to establish testing for detecting asbestos in talc products.
PFAS in Cosmetics
An assessment of the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products and the scientific evidence regarding their safety in cosmetic products must be issued no later than three years after enactment summarizing the results of the assessment conducted.
Sense of the Congress on Animal Testing
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 except for appropriate allowances.
If you manufacture and/or export products to the USA to sell to USA consumers, you need to get prepared!
- Put together a team to access the changes.
- Have a lead person.
- Make a Plan – conduct a GAP analysis to understand what you need to do (how many facilities need to be registered, how many product labels need to be changed etc.).
- Identify your US agent .
- Start working with your suppliers to confirm safety substantiation, fragrance allergens, etc.
- Update SOP’s for the new requirements and consider FDA inspection readiness.
- Implement the requirements.
- Engage with FDA when needed.
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