Importing Supplements into the US: The 4 Things Ecommerce Brands Need to Know 

The US is one of the largest and most lucrative markets for supplements, the revenue generated in the vitamins & minerals market in the United States amounts to US$4.79bn in 2025. However, getting your products across the border isn’t as simple as printing labels and pressing “ship.” For ecommerce merchants and brands importing supplements into the US, compliance with the Food and Drug Administration (FDA) regulations is non-negotiable and constantly updating; the latest guidance was launched early April 2025. From label requirements to facility registration and shipping documentation, every step matters. In this post, we’ll walk you through the must-know rules and red flags to help you import confidently and avoid costly delays. 

Dietary Supplements Are Regulated as “Food Products” 

Let’s start with the basics: in the eyes of the FDA, dietary supplements are considered a subcategory of food, but are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA), which is a different set of regulations from traditional food products.   If you’re importing these products into the US, your shipment must meet DSHEA standards around labeling, manufacturing, facility registration, and more. Failing to meet these rules could lead to your product being detained at the port—or outright rejected. 

This applies whether you’re shipping bulk inventory to a 3PL, drop shipping direct to consumer (DTC) from abroad, or anything in between. While some countries offer relaxed regulations for B2C shipments intended for personal use, the FDA does not recognize personal-use exemptions and only permits exceptions for non-commercial shipments. 

Labeling: Your First Line of Defense 

The label on your supplement is the first thing the FDA (and your customers) will see. It needs to be complete, accurate, and in English. 

At minimum, every imported supplement must include: 

• The identity of the product (e.g., “Vitamin D Supplement”) 

• The net quantity of contents (e.g., “60 capsules”) 

• A Supplement Facts panel listing nutrients, serving size, and % daily values 

• A full ingredient list, including inactive components 

• The name and US address of the manufacturer, packer, or distributor 

Even if your label looks great from a branding perspective, if it doesn’t follow FDA formatting rules, it could trigger detainment or a label revision request. 

Pro tip: The FDA doesn’t approve labels before import, but it absolutely enforces them at the port. 

Facility Registration: No Registration, No Entry 

One of the most overlooked (and critical) steps is making sure your foreign manufacturing facility is registered with the FDA. Without a valid registration, your shipment can’t legally enter the US. 

Here’s what you need: 

• An FDA registration number for each facility involved in manufacturing, packing, or holding your supplements 

• A Unique Facility Identifier (UFI), such as a Data Universal Numbering System (DUNS) number 

• Ongoing renewal: registration must be updated every even-numbered year (e.g., 2024, 2026) 

Don’t rely on your supplier to “probably have this.” Ask for the actual FDA registration number and verify it’s current. Your importer of record (IOR) may be asked to provide this info at entry. 

Prior Notice: Declare It Before It Ships

Before your supplement shipment reaches US soil, the FDA must receive a digital heads-up, known as Prior Notice. This lets the agency review incoming products and plan inspections, if needed. 

You (or your logistics partner) can submit Prior Notice via: 

• Customs and Border Protection’s ACE system The Automated Commercial Environment (ACE) is the system through which the trade community reports imports and exports and the government determines enforces compliance requirements. Prior Notice is to be filed via ABI, “Automated Broker Interface”. 

• FDA’s PNSI portal : The Prior Notification System Interface (PNSI) is used to provide notification to the FDA of imported shipments of articles of food prior to their arrival in the US. It is not for low volume direct shipments but meant for nuanced entries like, bonded entries, FTZ, post entry operations…etc.  

The notice must include: 

• Product name and classification code 

• Quantity and package type 

• Anticipated port of entry and arrival time 

• Manufacturer and shipper details 

🚨 Warning: If the FDA doesn’t get Prior Notice, your product will be held—no exceptions. 

Avoid These Common Red Flags 

Even compliant products get flagged at the border. The most common issues we see include: 

• ❗ Unregistered foreign facilities 

• ❗ Missing or incomplete Prior Notice 

• ❗ Labeling violations (especially missing Supplement Facts panels) 

• ❗ Ingredients not approved for dietary supplements 

• ❗ Unapproved disease claims (e.g., “cures anxiety” or “treats cancer”) 

If your product is flagged, you may face delays, storage fees, or even destruction of the goods. Stay ahead by auditing your suppliers, labels, and claims before you ship. 

Play It Safe: Claims and Manufacturing 

Your product must be safe, manufactured under Good Manufacturing Practices (GMPs), and not misleading to consumers. That includes what you say on the label, in your online store, and in your marketing. 

You can make “structure/function” claims like: 

• “Supports healthy digestion” 

• “Helps maintain energy levels” 

But you cannot make medical claims like: 

• “Cures IBS” 

• “Reduces cancer risk” 

Stick to what the FDA allows, and document the evidence behind your claims. 

Import Checklist for Supplement Sellers 

Here’s a simple checklist to help you stay compliant: 

• ✅ FDA-compliant labeling (double-check your Supplement Facts) 

• ✅ Registered foreign facility with a valid UFI (e.g., DUNS number) 

• ✅ Prior Notice filed for every shipment 

• ✅ Product manufactured under GMP standards 

• ✅ No unapproved disease or drug claims 

Getting your supplements into the US is doable—but it requires diligence. Build a compliance-first supply chain, educate your suppliers, and don’t cut corners. If you’d like help reviewing your import strategy let’s chat.