UPDATE! Navigating MoCRA: FDA Compliance + Important Deadlines

UPDATE! Navigating MoCRA: FDA Compliance + Important Deadlines

As your trusted partner in the cosmetics industry, Pravada Private Label is dedicated to guiding you through the complexities of the Modernization of Cosmetics Regulation Act (MoCRA). Keeping up with regulatory changes is vital for your business's compliance and success.

We recently attended COSMOPROF North America: Miami, where we had the opportunity to gain some important insight into MoCRA from the Personal Care Products Council (PCPC). The Personal Care Products Council is the leading national trade association representing and advocating on the behalf of companies in the cosmetics and personal care products industries.

Here, we provide an updated overview of the key deadlines and guidance on how you can navigate this process, either independently or with our assistance.

Key MoCRA Deadlines

  1. Mandatory Facility Registration (By July 1, 2024): Pravada has already completed facility registration and can provide our FDA Establishment Identifier (FEI) number upon request. Likewise, you are able to use the FEI Search Portal to find any registered facility's FEI.  If you purchase bulk product and package yourself, you may be required to register as a facility.  See below for guidelines.

  2. Product Listing (By July 1, 2024): All cosmetic products must be listed with the FDA, unless you meet small business guidelines listed below. Registrations must be renewed annually. For products already on the market, listing should be done within a year of enactment, while new products require listing within 120 days of U.S. market entry.

  3. Adverse Event Reporting Requirements (As of December 29, 2023): Companies are required to submit reports of any serious adverse event associated with their cosmetic products. These must be reported within 15 business days of receipt, with a record-keeping duration of six years.

  4. Cosmetic Labeling for Professional-Use Products (As of December 29, 2023): Professional-use cosmetic products must have labels indicating they are only for licensed professional use.

Unsure if Your Company will be Required to Register Your Facility or Products?

Generally speaking your facility will only need to be registered if your company or "facility" packages or processes any products itself and is not considered a small business. For instance, if you purchase bulk products from Pravada and fill them into final packaging yourself then you will most likely need to register. 

Regardless of facility registration, if you have annual revenue totals of more than $1,000,000 over the past three years from products sold in the US market, then you will need to register your products with the FDA. 

Your Path to Compliance: DIY or Pravada's Assistance

For clients who wish to handle the registration process independently, the FDA has launched "Cosmetics Direct," an electronic submissions portal for registration and listing, which can be accessed at direct.fda.gov. This platform, along with FDA's guidance documents, will aid you in successfully navigating the registration requirements.

However, if the process seems overwhelming or time-consuming, Pravada Private Label is here to help. Our registration services are available starting at $250 per product. By opting for our services, you will receive:

  • Expert handling of the entire registration process.
  • Time-saving benefits, allowing you to focus more on your business.
  • Login credentials for your company upon completion of the registration, providing access to all necessary documentation and updates.

Partnering for Success

Whether you choose to manage the registration process independently or seek our assistance, Pravada Private Label is committed to ensuring your smooth transition into MoCRA compliance. For further inquiries or to utilize our services, please feel free to contact us.

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