NEWS & BLOGS

FDA MoCRA Latest Update: Why Regulatory Delays Can Be Your Opportunity

Provision Consulting Group
Oct 3
2 min read

Companies looking to enter the U.S. cosmetics market should pay close attention to the latest news from the FDA regarding MoCRA (Modernization of Cosmetics Regulation Act). Important regulations that were originally scheduled for release between 2024 and 2025 have been largely postponed, as confirmed in the FDA's official 2025 Fall Unified Agenda.

So, are these delays a benefit or a setback for the industry? This article will break down the latest updates from the FDA and outline what your company should be doing right now to prepare.

Key MoCRA Updates from the FDA

Delayed Fragrance Allergen Labeling Requirement
- Original Timeline: Announcement of the ingredient list by June 2024.
- New Timeline: Regulations not expected to be proposed until May 2026.
  → While the immediate requirement is delayed, you can use this time to start preparing your labels. (※Referencing the EU allergen regulation list can make this process much easier.)
Delayed Cosmetic GMP (Good Manufacturing Practice) Regulations
- Original Timeline: Final regulations by December 2024.
- Current Status: Still pending.
  → The GMP system is already a global standard. It's safer to start reviewing your internal quality systems now rather than waiting for the FDA's final regulations to be announced.

The reasons for these delays are believed to be related to the late 2024 FDA reorganization, changes in leadership and departments, administrative delays due to staffing shortages, and the federal government's “One-in, Ten-out Rule” regulatory policy.

Regulatory Delays = Time to Prepare

Many companies might think, "The regulations are delayed, so there's nothing to do right now." However, this is precisely the time when a significant gap can form between companies that are proactive and those that are reactive.

Your Preparation Checklist

Fragrance Allergens: Use EU standards to simulate your future label designs.
Quality Management: Start implementing a GMP manual based on the ISO 22716 standard.
Labels & Registration: Get all the basic documents ready that the FDA will eventually require.
Staff Training: Ensure your team is fully aware of MoCRA's core requirements (registration, safety, labeling).

While MoCRA is already in effect, the announcement of some specific regulations and guidelines, such as GMP and fragrance allergen labeling, has been delayed. This is the optimal time to prepare for a successful market entry.