MoCRA Compliance Guide: Key FDA Regulations & Deadlines

3 min read

As a trusted partner in the cosmetics industry, Next Beauty Labs is committed to guiding you through the complexities of the Modernization of Cosmetics Regulation Act (MoCRA). Staying ahead of regulatory changes is essential for ensuring compliance and the long-term success of your business.

Recently, we gained valuable insights into MoCRA from the Personal Care Products Council (PCPC)—the leading national trade association advocating for the cosmetics and personal care products industries.

Below, we provide an updated overview of MoCRA's key deadlines and offer guidance on how to navigate compliance—whether you choose to handle the process independently or with Next Beauty Lab's expert assistance.

Key MoCRA Deadlines

1. Mandatory Facility Registration (Deadline: July 1, 2024)

Next Beauty Labs has already completed facility registration and can provide our FDA Establishment Identifier (FEI) number upon request. You can also verify any registered facility using the FEI Search Portal.

If you purchase bulk products and package them yourself, you may be required to register as a facility. See below for eligibility guidelines.

2. Product Listing (Deadline: July 1, 2024)

All cosmetic products must be listed with the FDA, unless your business qualifies for the small business exemption (see criteria below).

  • Registrations must be renewed annually.
  • For products already on the market, listing must be completed within one year of MoCRA's enactment.
  • For new products, listing must be completed within 120 days of entering the U.S. market.

3. Adverse Event Reporting (Effective: December 29, 2023)

Companies must report any serious adverse event related to their cosmetic products.

  • Reports must be submitted within 15 business days of receiving the complaint.
  • Companies must maintain record-keeping for six years.

4. Cosmetic Labeling for Professional-Use Products (Effective: December 29, 2023)

All professional-use cosmetic products must be clearly labeled as "For Licensed Professional Use Only."

Does Your Company Need to Register Its Facility or Products?

Facility Registration Requirements

Your business may need to register as a facility if:

  • You package or process cosmetic products in-house.
  • You do not meet the small business exemption criteria.

For example, if you purchase bulk products from Next Beauty Labs and fill them into final packaging yourself, you will likely need to register your facility.

Product Registration Requirements

Regardless of facility registration, you must register your cosmetic products with the FDA if:

  • Your annual U.S. revenue from cosmetic products exceeds $1,000,000 (averaged over the past three years).

If you meet this threshold, each cosmetic product you sell in the U.S. must be listed with the FDA.

Your Path to Compliance: Handle It Yourself or Let Next Beauty Labs Help

If you prefer to manage your MoCRA registration independently, the FDA’s "Cosmetics Direct" electronic submissions portal is available at direct.fda.gov. This tool, along with FDA guidance documents, provides step-by-step instructions for successful registration and product listing.

However, if the process seems overwhelming or time-consuming, Next Beauty Labs offers comprehensive registration services, starting at $500 per product.

Why Choose Next Beauty Labs’s Registration Services?

  • Expert Management – We handle the entire registration process on your behalf.
  • Time-Saving Benefits – Focus on growing your business while we ensure compliance.
  • Full Access to Your Registration Data – We provide login credentials for your company, giving you complete access to all necessary documentation and updates.

Partnering for Success

Whether you choose to manage compliance independently or take advantage of Next Beauty Lab’s expertise, we are here to ensure your transition into MoCRA compliance is seamless and stress-free.

For further inquiries or to utilize our registration services, feel free to contact us today.