📅 Effective August 29, all cosmetics and beauty products subject to FDA and PGA restrictions must be registered on the FDA Portal before they can be shipped to the United States.

🧼 Examples of Affected Products

The following items are now subject to mandatory registration:

• Makeup
• Nail polishes
• Shaving creams
• Grooming products
• Perfumes
• Face and body cleansers
• Haircare products
• Moisturizers
• Other skincare items

❓ What Is an FDA Restriction?

FDA restrictions refer to regulatory requirements enforced by the U.S. Food and Drug Administration for products that may impact public health. These include labeling, safety, and ingredient standards for cosmetics and personal care items.

❓ What Is a PGA Restriction?

PGA stands for Partner/Participating Government Agency. A PGA is any U.S. government agency—such as the FDA—that sets specific rules and import requirements for certain commodities. Products under PGA oversight must meet these standards before entering the U.S.

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MoCRA Online Registration & FDA Product Listing Guide

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed.

This guide outlines the necessary steps and data fields to complete facility registration and product listing under MoCRA using the FDA Cosmetics Direct Portal.

🧭 Step 1: FDA Cosmetics Direct Portal

1. Go to: https://direct.fda.gov
2. Click “Create Account” or “Login” if you already have one
3. Complete the facility registration form online
4. After registering your facility, proceed to “Add Product Listing”
5. Submit each SKU (or grouped listing) with all required data and label files

6.       You’ll receive confirmation numbers and can export copies of your submission.

✅ Facility Registration Information (Attached an example on last page)

✅ Product Information (Per SKU) (Attached an example on last page)

Step 2:📦 Additional Data Elements needed for Stallion Express

📚 Resources & References

🧾 FDA Cosmetics Direct Portal: https://direct.fda.gov

📘 MoCRA Overview: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022

🏷️ FDA Cosmetic Labeling Guide (PDF): https://www.fda.gov/media/131311/download

📍 Facility Information – Example

📍 Product Information – Example (Per SKU)

🧾 Client Setup Requirements

To ensure smooth customs clearance and regulatory compliance, clients must complete the following setup steps:

🔹 Importer of Record (IOR) Setup

Clients must establish an Importer of Record (IOR) with our customs broker.
One-time cost: USD 150

🔹 Customs Bond

Clients are required to maintain an active customs bond for ongoing import activity.
Annual cost: USD 400

📋 Required Data Elements for CBP Filing

For all shipments subject to FDA and PGA regulations, the following data elements must be collected and submitted:

• fdaProgramCode: COS
• fdaProcessingCode:  → Please leave this blank
• fdaIntendedUseCode: Use 100 for personal use and 130 for consumer use
• fdaSourceTypeCode: 39
• fdaProductCodeNumber: You can find the appropriate codes using this link: https://www.fda.gov/industry/import-program-tools/product-codes-and-product-code-builder 

Fill out the attached Products Template along with the above details and send it to us at fda@stallionexpress.ca.

🚚 Next Steps for DDP Shipments

To proceed with DDP (Delivered Duty Paid) shipping:

• You must provide all PGA/FDA data elements during shipment creation.
• These details are essential for regulatory compliance.
• Any missing or incorrect information may result in delays or rejections during Customs and Border Protection (CBP) clearance.

• PGA Products Template (3).xlsx9 KB