MoCRA Compliance in 2026: What's Enforced, What's Pending, and What to Do Now

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

Last reviewed: 2026

The Modernization of Cosmetics Regulation Act (MoCRA) is the biggest expansion of FDA's authority over cosmetics in roughly 80 years. But it's rolling out unevenly — some obligations are fully enforced, while several headline rules keep slipping. This is your plain-English status check for 2026, with a clear "what to do now" for each piece.

What's enforced right now

Facility registration and product listing are live and enforced. MoCRA took effect December 29, 2023, and after a period of enforcement discretion, FDA began enforcing facility registration and product listing requirements in mid-2024. These are the obligations most likely to block U.S. market access if you ignore them.

• Facility registration — required under Section 607(a) of the FD&C Act for facilities that manufacture or process cosmetics for the U.S. market. Renew every two years. Filed on FDA Form 5066.

  
  

• Product listing — required under Section 607(c). Each cosmetic product must be listed, with annual updates. Filed on FDA Form 5067.

  
  

• U.S. Agent — foreign facilities must designate a U.S.-based agent as part of registration. (See do I need a U.S. Agent for cosmetics?)

  
  

• Responsible Person duties — including safety substantiation and serious adverse event reporting (see below).

  
  

Serious adverse event (SAE) reporting is in force. The Responsible Person must report serious adverse events to FDA within 15 business days. (See the 15-day rule explained.)

What's still pending

This is where 2026 gets interesting — several major rules are delayed:

• Fragrance allergen labeling — the proposed rule (Section 609(b)) was statutorily due in 2024 but is now expected in 2026, with a final rule likely not before 2027. Prepare using the EU allergen list. (Full guide.)

  
  

• Cosmetic GMP — the rule (Section 606) missed its deadlines and has been moved to FDA's "long-term actions" list. No near-term final rule. Prepare with ISO 22716. (Full guide.)

  
  

• Asbestos testing for talc-containing cosmetics — FDA withdrew its proposed standardized-testing rule in late 2025, so no final rule is expected in the short term.

  
  

• PFAS and state-level bans — FDA published a PFAS-in-cosmetics report at the end of 2025, but the more immediate pressure comes from a growing patchwork of state restrictions. (Full guide.)

  
  

Are small businesses exempt?

Some are — but read the fine print. MoCRA provides exemptions from registration, listing, and GMP for certain small businesses whose average gross annual U.S. cosmetic sales fall below the statutory threshold. However, that exemption does not apply to products that, under customary use, come into contact with the eye's mucous membrane, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours where removal isn't part of normal use. If you make those product types, you must register and list regardless of size.

What to do now: a 2026 priority checklist

1. Confirm your facility registration is active and renewed (two-year cycle).

   
   

2. Verify every marketed product is listed and update listings annually.

   
   

3. If you're a foreign facility, confirm your U.S. Agent designation is current.

   
   

4. Stand up SAE intake and 15-day

   reporting so you can meet the deadline if an event occurs.

   
   

5. Get ahead of pending rules: audit fragrance allergens against the EU list, and build GMP documentation to ISO 22716.

   
   

6. Screen formulations for PFAS against active state bans.

Want a single status report for your brand? Axentra runs a MoCRA readiness review covering registration, listing, U.S. Agent, adverse-event systems, and rule-by-rule exposure. Request a readiness review.

For the complete obligation set and how we support each one, see our MoCRA cosmetics compliance page and FDA's official MoCRA page.

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Frequently asked questions

What MoCRA requirements are actually enforced in 2026?

Facility registration, product listing, U.S. Agent designation for foreign facilities, safety substantiation, and serious adverse event reporting are all in force. The fragrance allergen and GMP rules are still pending.

Has the MoCRA GMP rule been finalized?

No. It missed its deadlines and is now a long-term action with no near-term final rule expected.

When is fragrance allergen labeling required?

The proposed rule is expected in 2026 and a final rule likely not before 2027, so it is not yet mandatory — but brands should prepare against the EU allergen list.

Are small cosmetic businesses exempt from MoCRA?

Some qualify for exemptions from registration, listing, and GMP based on sales thresholds, but the exemption does not apply to higher-risk product categories such as injectables, eye-area products, products for internal use, or products that alter appearance for more than 24 hours.