The US Food & Drug Administration (FDA) is now operationalizing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), delivering major increases in market visibility (registrations/listings), a step-change in adverse event reporting, and new enforcement leverage (mandatory recalls and records access).

What happened: A legislative shift

  • Historically, the FDA’s cosmetics authority changed little between the 1938 FD&C Act and 2022 (with the Fair Packaging and Labeling Act of 1967 as a notable exception). Cosmetics companies were responsible for product safety, but key oversight mechanisms (e.g., mandatory facility registration, product listing, and serious adverse event reporting) were not required
  • On Dec 29, 2022, Congress enacted MoCRA, significantly expanding the FDA’s authority and establishing substantial new requirements for companies marketing cosmetics in the US

What the FDA can do now:

  • Mandatory recall authority for cosmetic products
  • Records access authority (FDA can access certain records)
  • Required serious adverse event reporting by “responsible persons,” plus required recordkeeping to demonstrate adequate substantiation of product safety

What industry must do: Core compliance obligations

  • Facility registration: cosmetic manufacturers/processors must register facilities with the FDA (with certain small business exemptions)
  • Product listing: responsible persons must list marketed cosmetic products with the FDA, including ingredients (with certain small business exemptions)
  • Serious adverse event reporting: now mandatory (previously voluntary), plus maintenance of related records
  • Safety substantiation: maintain records supporting “adequate substantiation” of cosmetic product safety
  • Prepare for forthcoming/expanded requirements:
    • Fragrance allergen labeling regulations (FDA is directed to establish).
    • Standardized asbestos testing methods for talc-containing cosmetic products (FDA directed to establish)
    • Cosmetic Good Manufacturing Practice (GMP) regulations (FDA directed to establish; includes exemptions for certain small businesses from GMP requirements)

FDA implementation progress: What has the FDA put in place?

  • Guidance and tools: The FDA issued multiple guidance documents and developed tools supporting facility registration and product listing
  • Submission infrastructure: The FDA launched “Cosmetics Direct” (electronic submissions portal), alongside ESG NextGen and paper options
  • Adverse event reporting enablement: The FDA updated tools/applications to support mandatory serious adverse event reports
  • Enforcement clarity: The FDA issued draft guidance addressing mandatory recall and records access authorities for cosmetics
  • GMP rule development: The FDA held a virtual listening session with manufacturers (including small businesses and contract manufacturers) and consumer organizations to inform GMP regulations
  • Transparency: The FDA began providing regularly updated summary data on facility registrations and product listings (beginning by March 2025)

Early impact and key data points: Why this is already changing oversight

  • Adverse event reporting: reports submitted by industry increased by more than three-fold after MoCRA implementation (versus the prior voluntary system)
  • Public visibility: adverse event data are now accessible via a single FDA Adverse Event Monitoring System dashboard, which the FDA expects will drive more detailed reporting from consumers, healthcare providers, and the public
  • Market scale now visible to the FDA:
    • 15,000 unique, active cosmetic facility registrations
    • 1,000,000 unique, active cosmetic product listings
    • Pre-MoCRA (Voluntary Cosmetic Registration Program): 5,176 establishment registrations and 35,102 product listings
    • The FDA interprets this as nearly a 3x increase in registered facilities and a ~30x increase in product listings—underscoring the expanded reach and scale of FDA oversight

FDA Targeted topic: PFAS in cosmetics (enabled by mandatory listings)

  • MoCRA required the FDA to assess PFAS use and associated safety evidence/risks
  • The FDA published a December 2025 report reviewing safety information for the 25 most commonly used PFAS in US-marketed cosmetics, identified using the new mandatory product listings
  • PFAS-containing cosmetic products represented 0.41% of total products listed as of August 2024 (per the article)

FDA continuing “legacy” cosmetics oversight

  • The FDA continues regulatory/compliance activities under existing authorities, including:
    • Final guidance related to microbial contamination risk in tattoo inks
    • 2025 consumer alert on gel nail polish removers containing methylene chloride (a prohibited cosmetic ingredient at any level, per FDA)

FDA Organizational note:

  • In 2024, FDA’s Office of Cosmetics and Colors moved from CFSAN to the Office of the Chief Scientist to better align with its core mission

What to do now: Practical actions for responsible persons

1. Confirm MoCRA operational compliance

    • Verify facility registration coverage across owned and contract manufacturing/processing sites
    • Reconcile product listings vs. actual U.S. marketed portfolio; confirm ingredient data completeness and change-control procedures

    2. Strengthen post-market surveillance and reporting readiness

      • Ensure intake channels, triage criteria, investigation workflows, and submission timelines for serious adverse events are defined and trained
      • Implement quality checks to improve report completeness (anticipate increased public and regulator scrutiny due to dashboard transparency)

      3. “Audit-proof” safety substantiation and records access preparedness

        • Maintain readily retrievable safety substantiation files (claims support and safety rationale where applicable)
        • Ensure record retention, version control, and rapid retrieval processes in case FDA exercises records access authority

        4. Prepare for next-wave regulatory requirements

          • Monitor FDA rulemaking on cosmetic GMPs, fragrance allergen labeling, and standardized asbestos testing methods (especially for talc-containing products)
          • Assess whether any small business exemption applies—and what that means for your operational model and partner network

          How Lumanity can help

          1. MoCRA readiness and compliance program build
          2. Facility registration and product listing execution support
          3. Post-market surveillance and serious adverse event reporting
          4. Safety substantiation and “records access” readiness
          5. GMP and quality system preparedness (ahead of FDA GMP rulemaking)
          6. Forward-looking regulatory strategy (fragrance allergens, talc/asbestos methods, PFAS)

          Organizations that build a scalable compliance foundation now will be better prepared for future waves of regulatory updates.

          Contact us

          Discuss your MoCRA readiness with our expert team and find out how we can support you—contact us.