In Pravada’s ongoing commitment to keep you informed with updates regarding MoCRA as we receive them from the FDA, we wanted to share and discuss the latest draft guidance the FDA released on the product registration process planned for implementation by the end of 2023.
The following provides a brief summary of the guidance document as it relates to brand owners — you will find a link to the full document below. Please note that this information has been provided by the FDA on a draft basis and is subject to change over the next few months.
First, if you are unsure about what MoCRA is and possibly missed our last blog post and newsletter, please click here to learn about what MoCRA is!
In the simplest of terms, MoCRA essentially requires brand owners to register their products with the FDA through an online portal (still under development).
Before you Begin
Important to note before you begin is that small businesses/brands are exempt from registering – if you have sales of less than $1,000,000 over the past three years you will not be required to register your products.
For those that must register the products, here is a quick breakdown as we currently understand the process. There will be further clarification issued over the next few months as the FDA finalizes these details and implementation of the registration process.
Who is the ‘Responsible Person’?
Essentially, the brand owner is considered the ‘responsible person’ for each product. The name of the entity that is on the product label, will be considered the responsible person as per Section 604(4) of the FD&C Act. The purpose of this is to have the appropriate point of contact if there is a problem reported to the FDA regarding the product.
What Will be Included in the Product Listing?
- Facility registration number for each facility where the cosmetic product is manufactured or processed – we will supply our registration number once we receive this from the FDA.
- Name and contact details of the responsible person along with the name of the product (as labeled).
- Relevant, applicable cosmetic category or categories for product – there is a list to choose from in the registration.
- Comprehensive ingredient list – we will provide this to you if there are any changes once MOCRA is implemented.
- There will be an option to list multiple products with identical or slightly varying formulations (in terms of color, fragrance, or flavor) in a single submission.
The FDA also has indicated they will be requiring the following additional information:
- Parent company name
- Label images
- Business type (as listed on label, i.e., manufacturer, packer, or distributor) – in most cases we expect brand owners will be considered distributors.
- Product webpage links
- Unique Ingredient Identifiers (UNII) numbers (which can be found here)
- Whether the product is for professional use only
- Responsible person DUNS number for address listed on product label. In advance, if your company does not have a DUNS number you may want to register now. Here is a link.
What is the Timeline for Product Listing Registration
- Initial Listing: If your cosmetic product was in the market by December 29, 2022, you must submit its listing by December 29, 2023. For products introduced after December 29, 2022, the listing should be done within 120 days from its market introduction or by December 29, 2023, whichever is later.
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Updates and Renewal: Yearly updates are essential, even if the only update is discontinuation. Fortunately, it appears the FDA will streamline the renewal process for unchanged product listings.
Are there any Associated Fees?
To date there are no fees required by the FDA for these submissions. If your company or products fall within the threshold required to file, you can submit all documentation on your own behalf. However, if you would like assistance with the submission process to ensure seamless and accurate documentation, Pravada will offer filing services for a to be determined fee. We will let you know once we have a full understanding of the work required to process a registration.
Should you need further assistance or clarification, don't hesitate to give us call at (239) 260-9826 or send us an email at info@pravada.com.
