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MoCRA in 2026: GMP and fragrance-allergen rules still pending, recall power already live

Law firm Foley & Lardner summarized where FDA cosmetics oversight stands in 2026. Think of it as a "next step" check for teams that already handled the MoCRA basics (facility registration, product listing, safety substantiation).

Already in force

  • As of January 2026, FDA's database held 14,299 active facility registrations and 992,907 active product listings, so the agency sees far more of who makes what, and where.
  • Mandatory recall authority for adulterated or misbranded products posing serious health risk; draft recall guidance came out in December 2025

Still not final

  • Final GMP rules: not issued as of January 2026, expected soon and likely central to future inspections
  • Fragrance allergen labeling: not finalized; labels will need changes once thresholds are set
  • PFAS: a December 2025 report found significant safety uncertainty due to data gaps
  • Talc asbestos testing: proposed rule withdrawn in November 2025, a revised approach is coming

The advice is simple: audit your quality systems before the rules land.

US exporters: are you already moving fragrance allergen labels to the EU standard, or waiting for FDA's final rule?

Source: Foley & Lardner — How MoCRA Is Reshaping FDA Oversight of Cosmetics in 2026

#MoCRA #FDA #USExport #CosmeticsRegulation

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