📅 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.
Here’s what you need to know:
• Your manufacturer must be registered with the U.S. FDA
• You must submit your product listing under MoCRA (Modernization of Cosmetics Regulation Act)
• Enroll Product on Stallion for Classification To utilize DDP (Delivered Duty Paid) postage, the product must be enrolled and classified through Stallion.
• Update Product Details for CBP Filing On the Products page, ensure the FDA Product Code and all required data elements are included in the approved product details for Customs and Border Protection (CBP) filing.
• Set Up Importer of Record (IOR) and Customs Bond - For new clients or those without an existing record with our customs broker, establishing an Importer of Record (IOR) and securing a Customs Bond is required prior to shipment. Contact us to initiate the setup process with our designated customs broker.
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.
Go to: https://direct.fda.gov
Click “Create Account” or “Login” if you already have one
Complete the facility registration form online
After registering your facility, proceed to “Add Product Listing”
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.
🧾 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
🧾 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
fdaProcessingCode → Use M for FDA
fdaIntendedUseCode
fdaSourceTypeCode
fdaProductCodeNumber
🚚 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.