FDA-cosmetic-regulations MoCRA update, 21 U.S. Code § 364

Cosmetic FDA Regulations (MoCRA)

New FDA regulations for cosmetic products: Updates to the US Federal Food, Drug, and Cosmetic Act (FD&C Act) and Title 21 USC 364 (FDA Cosmetic Regulations).

MoCRA: FDA cosmetic manufacturing regulations

  • The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 represents 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.
  • MoCRA is expanding the cosmetic regulation outlined in the FD&C Act, giving the FDA greater oversight over cosmetic sales and cosmetic manufacturing in the United States.
MoCRA: Effective date for FDA Cosmetic Regulations

Most of the provisions in MoCRA take effect at the close of 2023. These include mandatory facility registration requirements (for cosmetic product manufacturers) and mandatory reporting of adverse events to the FDA, within designated timeframes. The FDA can also mandate a product recall where necessary.

MoCRA, in effect as of late 2023, means cosmetics will soon be regulated similarly to a drug or medical device in the United States.

Background to MoCRA (new FDA cosmetic product regulations)

Expansion of US FDA Regulatory Oversight of Cosmetic Products

Before the passage of MoCRA, the United States Food & Drug Administration (FDA) had limited authority regarding cosmetic product registration and GMP requirements.

Before the new FDA cosmetic regulations (going into effect in late 2023), the FDA had:

  • Limited authority over cosmetic product registration, cosmetic product testing, premarket notification, clearance or approval.
  • Limited authority over good manufacturing practices (GMP) for cosmetic products; mandatory risk labeling; adverse event reports; and cosmetic product recalls.

The US FDA could not impose registration requirements on cosmetic manufacturers, yet manufacturers could voluntarily comply with US FDA registration regulations.

Source: CRS R47826, FDA news releases.

MoCRA (Modernization of Cosmetic Regulations Act) broadens the FDA’s regulatory authority over cosmetic and personal care products. This includes mandatory facility registrations, obligatory reporting of adverse events, and granting the FDA the authority to mandate product recalls for cosmetics when necessary.

FDA-cosmetic-regulations MoCRA update, 21 U.S. Code § 364

Note: Other regulations are applicable to cosmetic products, such as the Fair Packaging and Labeling Act (FPLA), the Color Additive Amendments Act of 1960, and the Poison Prevention Packaging Act of 1970.

Modernisation of Cosmetics Regulation Act (MoCRA) of 2022

Cosmetic Manufacturing Regulatory Compliance

On December 29, 2022, the FD&C Act was updated with the passing of the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, detailing new regulatory compliance requirements for cosmetic manufacturers.

In addition to meeting ISO 22716 requirements, cosmetic products made or distributed in the United States must comply with the Federal Food, Drug, and Cosmetic (FD&C) Act.

The FDA is publishing further updates about MoCRA (for cosmetic manufacturers) in late 2023.

FDA-cosmetic-regulations MoCRA update, 21 U.S. Code § 364

MoCRA (Title 21 USC 364)

Cosmetic Registration and Product Listing Overview

Starting on December 29th 2023, cosmetics manufactured and sold in the United States are required to be registered with the FDA. Previously, cosmetic registration with the FDA was voluntary. The FDA’s GMP rules for cosmetic products will also apply and the FDA is expected to increase regulatory compliance oversight in this industry, with mandated reporting of adverse events/harmful reactions related to use of cosmetic products.

In the November 1st FDA update regarding MocRA, the agency strongly encourages these registrations to be done electronically.

FDA-cosmetic-regulations MoCRA update, 21 U.S. Code § 364

The FDA will give more details in the coming weeks on the launch date for electronic registration submission.

Here’s a brief overview of how the new FDA cosmetic regulations for cosmetics will impact manufacturers.

Cosmetic Manufacturers: Regulations & Registration requirements

FDA-cosmetic-regulations MoCRA update, 21 U.S. Code § 364

When do cosmetic manufacturers have to register with the FDA?

Existing facilities

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 December 29, 2023.

New facilities

FDA registration requirements for new cosmetic facilities (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.

Cosmetic Products Regulations & Structured product labelling (SPL) framework.

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.

What is meant by “SPL”?

SPL is the acronym for ‘structured product labelling’.

It is a document markup standard developed by Health Level Seven International (HL7), and adopted by the FDA for electronically exchanging drug product and manufacturing facility information. This format enforces consistent structure and standard terminology when submitting product labels to the FDA.

SPL documents include a header and a body of text.

  • The header can include information such as the type of product, author, and versioning.
  • The body of the document can include product information in both structured text and data element formats.

Cosmetic Product Manufacturing & Validation Protocols

Implementing SLP and Validation Protocols for Cosmetic Facility Registrations and Product Listings (SPL Coding/SPL Guidance)
  • In October 2023, the FDA released new guidance on implementing SPL that includes validation protocols for cosmetic product facility registrations and product listings.
  • The updated SPL guidance is not limited to just cosmetics; and includes sections covering drugs, biologics, and medical devices as well.
  • This is a highly technical document reviewing the line-by-line coding required for this SPL framework. Click here to read a new FDA media release covering SPLs.

GMP Updates to the Federal Food, Drug, and Cosmetic Act

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) updates the FD&C Act by granting the FDA additional authority over the manufacture and sale of cosmetics in the United States.

Previously, the FDA did not have an official code addressing Good Manufacturing Practice (GMP) for cosmetic products, and 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).

Need consultancy expertise for your cosmetic facility design, your cosmetic facility quality management system, and/or GMP compliance? Click here to review cosmetic industry services from PharmOut.

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 will work to establish and require a standard testing method for detecting and identifying asbestos in talc-containing cosmetic products. A draft regulation will be announced by January 2024 for industry feedback.

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)

Cosmetic product definition - FDA definitions

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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