FDA & PGA Compliance Guide for Cosmetics and Beauty Products

📅 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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✅ Steps for FDA/PGA and Customs Compliance
 

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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.

 

 

 

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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)

Field	Your Response
Facility Legal Name
Facility Address
DUNS Number
U.S. Agent (if foreign)
Contact Person (Name & Email)

 

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

Field	Your Response
Brand Name
Product Name
Product Category
Product Description
Ingredient List (INCI format)
Package Size & Units
Responsible Person (Label Info)
Product Label File (PDF/Image)

 

Step 2:📦 Additional Data Elements needed for Stallion Express

 

Element	Description
FDA Product Code	FDA-specific 5-digit identifier for the product
Intended Use Code	Indicates the purpose (e.g., cosmetic use)
HTS Code	Harmonized Tariff Schedule code (e.g., 3304.99.00.10)
Manufacturer Info	Name, address, DUNS, or FEI if applicable

📚 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

Field	Example / Format
Facility Legal Name	ABC Skincare Labs Ltd.
Facility Address	123 Cosmetic Ave, Seoul, Korea
DUNS Number	123456789
U.S. Agent (if foreign)	[Your U.S. Agent or firm’s contact]
Contact Person	John Smith, Regulatory Manager

 

📍 Product Information – Example (Per SKU)

Field	Example / Format
Brand Name	Glow Essentials
Product Name	Aloe Hydrating Serum
Product Category	Face Creams, Lotions
Product Description	Non-medicated serum for hydration
Ingredient List (INCI)	Water (Aqua), Glycerin, Aloe Barbadensis Leaf Extract...
Package Size & Units	50ml glass bottle
Product Image or Label (PDF)	Upload or attach file
Responsible Person (on label)	[e-mail]

 

 

🧾 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.