MoCRA Cosmetic GMP Rule: Where It Stands in 2026 — and Why You Shouldn't Wait

By Alok Naik, R.Ph., M.S. Regulatory Affairs — Managing Partner, Axentra Global Pharma Compliance LLC

MoCRA gave FDA the authority to establish, for the first time, federal Good Manufacturing Practice (GMP) requirements for cosmetics. Years in, that rule still isn't on the books — and the uncertainty is exactly why proactive manufacturers are building GMP-style systems now.

What is the MoCRA cosmetic GMP requirement?

Section 606 of the FD&C Act, as added by MoCRA, directs FDA to issue regulations establishing good manufacturing practices for facilities that manufacture or process cosmetic products. The intent is to bring cosmetics closer to the kind of documented, inspectable quality systems that already govern drugs, dietary supplements, and food — covering areas such as recordkeeping, contamination controls, and production consistency.

Importantly, MoCRA directs FDA to consider national and international standards. A large share of industry comments have pointed to ISO 22716, the international GMP standard for cosmetics already required across the EU, as the natural reference point.

When will the cosmetic GMP rule take effect?

Here's the current reality: it's delayed, with no firm date. MoCRA required FDA to issue a proposed GMP rule by December 29, 2024, and a final rule by December 29, 2025. Both deadlines passed. In the most recent Unified Agenda, cosmetic GMP rulemaking was reclassified as a "long-term action" — regulatory shorthand for "deferred indefinitely." A final, enforceable GMP rule is therefore not expected in the near term.

That does not mean GMP is irrelevant today. FDA's existing authorities over adulteration still apply, inspections continue, and customers, retailers, and contract partners increasingly expect documented quality systems regardless of whether a federal rule is final.

How to prepare for cosmetic GMP now

Because FDA is statutorily pointed toward recognized standards, you can prepare with high confidence:

• Adopt ISO 22716 as your operating framework. It is the most likely reference point for the eventual U.S. rule and is already the EU benchmark. Building to it now means you're aligned with whatever FDA finalizes — and you're export-ready for Europe at the same time.

  
  

• Document what you already do. Many manufacturers meet much of the substance of GMP but lack the records to prove it. Written procedures, batch records, supplier qualification, and complaint handling are the gaps that show up first in an inspection.

  
  

• Map quality to your registration and listing data. Your facility registration and product listings should reflect what you actually manufacture; GMP documentation should tie back to those records.

  
  

• Treat contract manufacturers as part of your system. If a CMO makes your product, their quality systems are effectively yours in the eyes of FDA. Qualify them accordingly.

Not sure how close your operation is to GMP-ready? Axentra runs cosmetic GMP gap assessments mapped to ISO 22716 and the anticipated U.S. framework. Request a gap assessment.

The cross-border advantage

Axentra's team works across U.S., EU, and PIC/S frameworks, so our GMP guidance isn't built on guesswork about what FDA might do — it's anchored in the ISO 22716 standard FDA is most likely to mirror. For the broader implementation picture, see where MoCRA stands in 2026, and if you haven't registered yet, start with how to register a foreign cosmetic facility. Full service detail is on our MoCRA cosmetics compliance page, and you can track the rule on FDA's MoCRA page.

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Frequently asked questions

Are cosmetic GMP requirements mandatory under MoCRA yet?

Not as a specific federal GMP rule. FDA missed its statutory deadlines and reclassified cosmetic GMP as a long-term action, so no final GMP regulation is in force as of 2026. General adulteration and safety authorities still apply.

What standard will the MoCRA GMP rule be based on?

FDA is directed to consider national and international standards. ISO 22716 — the international cosmetic GMP standard already required in the EU — is the most widely expected reference point.

Why prepare for GMP if the rule is delayed?

Inspections, retailer requirements, and contract-manufacturing expectations already demand documented quality systems. Building to ISO 22716 now avoids a rushed buildout when FDA does finalize the rule and makes you EU-export-ready.

Which law authorizes cosmetic GMP?

Section 606 of the FD&C Act, added by MoCRA, gives FDA authority to establish good manufacturing practice regulations for cosmetic facilities.