Cosmetic FDA Regulations (MoCRA)
Modernization of Cosmetics Regulation Act (MoCRA) – Part 1 of 2 resource articles. This article introduces US FDA regulations for cosmetic products.
Modernization of Cosmetics Regulation Act (MoCRA) of 2022
On December 29, 2022, the FD&C Act was updated with the passing of the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. This regulation detailed new regulatory compliance requirements for cosmetic manufacturers and distributors.
Manufacturers and distributors of cosmetic products in the US are required to comply with these updated requirements. The FDA continues to publish updates about MoCRA compliance (for cosmetic manufacturers) including the latest FDA guidance on facility and product registration (December 2024).
History of Cosmetic Regulations in the United States
MoCRA: FDA cosmetic manufacturing regulations
- The Modernization of Cosmetics Regulation Act (MoCRA) represented the most noteworthy expansion of the FDA’s authority to regulate cosmetics and personal care products since the inception of the FD&C Act in 1938.
- These new FDA regulations for cosmetic products expanded the requirements outlined in the FD&C Act.
‘MoCRA’ gave the FDA greater oversight over cosmetic sales and cosmetic manufacturing in the United States.
MoCRA Modification of the US FD&C Act (21 USC 364c)
- MoCRA added Section 607 to the FD&C Act (21 U.S.C. 364c).
- MoCRA established mandatory requirements for cosmetic product facility registration and cosmetic product listing in the United States (US).
- MoCRA also provided additional FDA oversight, and more stringent quality assurance requirements for cosmetic product manufacturers & distributors, to protect the public from potentially harmful cosmetic products and ingredients.
MoCRA Effective Date
- Many of the provisions outlined in the FDA’s new cosmetic regulations (MoCRA) were to go into effect at the close of 2023.
- However, the deadline to comply with MoCRA, including registration requirements, was extended to 1 July 2024.
MoCRA means that cosmetic products manufactured or distributed in the US are now regulated similarly to a drug products and medical devices in the United States.
Background to MoCRA (FDA Cosmetic facility & cosmetic product regulations)
US FDA Regulatory Oversight
Before the passage of MoCRA, the United States Food & Drug Administration (FDA) had limited authority regarding cosmetic product registration and GMP requirements.
- The FDA’s previous system for ‘voluntary registration’ of cosmetics gave the FDA limited authority over cosmetic product registration, cosmetic product testing, premarket notification, clearance or approval.
- It also meant the FDA had minimal authority over enforcing compliance with Good Manufacturing Practices (GMP) for cosmetic products; e.g., no mandatory risk labeling; no mandated reporting of adverse events; no oversight of contamination prevention and other quality and safety controls, and not being able to mandate a cosmetic product recall.
The US FDA could not impose registration requirements on cosmetic manufacturers, although manufacturers could voluntarily comply with US FDA registration regulations.
Source: CRS R47826, FDA news releases.
MoCRA (Modernization of Cosmetic Regulations Act) broadened the FDA’s regulatory authority over cosmetic and personal care products, including:
- Mandating facility registrations and product registrations,
- Making reporting of adverse events mandatory, and
- Granting the FDA the authority to mandate product recalls for cosmetics when necessary.
Reminder: Additional regulations remain applicable to cosmetic products in the US, such as the Fair Packaging and Labeling Act (FPLA), the Color Additive Amendments Act of 1960, and the Poison Prevention Packaging Act of 1970.
MoCRA (Title 21 USC 364)
Cosmetic Registration and Product Listing Overview
As of 1 July 2024, the MoCRA (cosmetic products) laws in the United States means all cosmetic manufacturing facilities and products manufactured and sold in the US are required to be registered with the FDA. To learn more about the actual registration process in the FDA’s Cosmetic Direct platform, click here (opens in new tab).
The agency strongly encourages these registrations to be done electronically and continues to support cosmetic industry stakeholders with updated registration guidance, the latest guidance published in late 2024 for comments through early 2025.
A brief overview of how new FDA regulations for cosmetics will impact manufacturers.
Cosmetic Manufacturers: Regulations & Registration requirements
When do cosmetic manufacturers have to register with the FDA?
FDA registration requirements for existing cosmetic facilities:
- Excerpt: (A) Every person that [on December 29, 2022] owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the [Secretary of Health and Human Services] no later than 1 July 2024 (extended from 29 December 2023).
New cosmetic manufacturing facilities (2023 and onwards)
- Excerpt: (B) Every person that owns or operates a facility that first engages, after December 29, 2022, in the manufacturing or processing of a cosmetic product for distribution in the United States, shall register with the [Secretary of Health and Human Services] within 60 days of first engaging in such activity or 60 days after the deadline for registration under subparagraph (A), whichever is later.
US FDA Cosmetic Regulations require data inputs using Structured Product Labelling (SPL) Frameworks.
- Cosmetics product facility registrations and product listings are now required to follow the structured product labelling (SPL) framework.
- SPL is a standard FDA requirement for all drug and pharmaceutical registrations in the United States, and as per the new MoCRA, cosmetics will now fall under this framework as well.
GMP Compliance & MoCRA
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) granted the FDA additional authority over the manufacture and sale of cosmetics in the United States. It also gave the FDA oversight of ‘GMP’ compliance (“Good Manufacturing Practice” requirements) for cosmetic product manufacturing.
Previously to MoCRA and updates to the FD&C Act, the FDA did not have an official code addressing Good Manufacturing Practice (GMP) for cosmetic products. Instead, the FDA encouraged the internationally accepted standard ISO 22716. MoCRA now allows the FDA to define specific regulations around GMP for cosmetic product manufacturing.
Some examples of the expanded FDA powers (and new cosmetic product GMP requirements) that will impact cosmetic manufacturers as MoCRA goes into effect, include:
- Records Access: In certain circumstances, the FDA will be able to access records related to a cosmetic product, including safety records (21 USC 364f).
- Mandatory Recall Authority: The FDA can order a mandatory recall of a cosmetic product (if the responsible person refuses to do so voluntarily). This might be necessary where a cosmetic product causes severe adverse health effects or becomes adulterated (21 USC 364g).
- Adverse Event Reporting: A responsible person must report serious adverse events due to cosmetic products in the United States to the FDA within 15 business days (21 USC 364a).
- Safety Substantiation: A responsible person is required to “ensure, and maintain records supporting, that there is adequate substantiation of the safety of such cosmetic product” (21 USC 364d(a)). In other words, there is no mandate on specific tests performed on cosmetics, but there must be evidence or information supported by scientific experts to show that the cosmetic product is safe for use.
- Good Manufacturing Practice: By January 2026 the FDA will establish GMP regulation regarding cosmetic products. Until this point, the FDA did not have specific regulations for cosmetics, but strongly advised manufacturers to adhere to GMP principles. Because there will be new GMP regulation for cosmetics, the following FDA GMP cosmetic guidance has been reverted to draft for further review (21 USC 364b).
Cosmetic Products Adverse Event Reporting: Example of a Practical Application
“Before MoCRA was enacted, the FDA relied exclusively on voluntary reports of adverse events from cosmetic companies and consumers. The public could report adverse events
to the US FDA via MedWatch, the FDA’s product safety reporting program. Under MoCRA, a responsible person for a particular cosmetic product used domestically must report associated serious adverse events.” Excerpted from CRS Report R47826.
MoCRA Addressing Industry Concerns
The Modernization of Cosmetics Regulation Act of 2022 also considers the additional burdens small businesses face and the growing concern over asbestos contaminating talc mining sites:
- Small Business Exemptions: Certain small businesses may be exempt from FDA registration requirements, product listing requirements and GMP for their cosmetic products if they have a low-risk product(21 USC 364h).
- Talc-Containing Cosmetics: The FDA continues to work to establish and require a standard testing method for detecting and identifying asbestos in talc-containing cosmetic products.
- Learn more about Talc in cosmetic products.
Get In Touch
These new FDA regulations for cosmetic products will see the United States cosmetic industry experiencing a lot of unprecedented changes over the next few years.
It is exciting to see the FDA taking major strides (with the Modernization of Cosmetics Regulation Act of 2022 ) to address GMP in cosmetic manufacturing— to ensure end-users receive a safe and quality product.
Want a GMP refresher? Read Cosmetics Good Manufacturing Practices and our training offering Cosmetics GMP Training – ISO 22716
Still have questions? Reach out to PharmOut for help on navigating cosmetic GMP.
Definition of a cosmetic product (US FDA)
FFDCA (FDA) definition of ‘cosmetic’ products: The FDA defines a “cosmetic” as an article intended to be “applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.” The term covers a broad range of FDA-regulated products that may be used externally and internally…[including] products for the eyes, face, nails, hair, skin, and mouth, such as makeup, nail polish, hair dyes and colouring, suntan preparations, fragrances, oral care, and bath products. Although soap was explicitly exempted from the definition of a cosmetic, it may be regulated by the FDA as a cosmetic product in certain instances. In addition, coal-tar hair dye was provided a limited exemption from the FFDCA’s adulteration provisions. Inks used for tattooing are also classified as cosmetics under the FFDCA. Under MoCRA, FFDCA will separately define a “cosmetic product” as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.” Sources: FDA Regulation of Cosmetics and Personal Care Products Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and CRS R47826.
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