Exporting Dietary Supplements to the USA: A Buyer’s Guide to FDA DSHEA Labeling Compliance

The United States is the single largest dietary supplement market in the world, worth well over $60 billion a year. For overseas brands and Amazon sellers, it is the market everyone wants a slice of. Yet a surprising share of first shipments never make it past the border — not because the product is bad, but because the label is wrong.

If you are sourcing from a Chinese OEM/ODM factory and selling into the US, this guide walks through the labeling rules that actually matter, the mistakes that get products detained or recalled, and what you should confirm with your manufacturing partner before you print a single carton.

Who Regulates Supplements in the US?

Two agencies matter. The FDA regulates the product itself under the Dietary Supplement Health and Education Act (DSHEA, 1994), which treats supplements as a subcategory of food. The Federal Trade Commission (FTC) regulates advertising, and requires that all claims be truthful and substantiated.

Under DSHEA, supplements do not need pre-market approval from the FDA. That sounds like freedom — but it actually shifts the entire compliance burden onto you and your factory. Nobody reviews your label before it hits the shelf. If it is wrong, the FDA finds out later, and by then the product is on the market.

The Mandatory Label Elements

Every dietary supplement sold in the US must carry the following, per 21 CFR 101.36:

• Statement of identity — what the product is (for example, “Dietary Supplement”).
• Net quantity of contents — in both metric and US customary units for liquids; count or weight for solids.
• “Supplement Facts” panel — the US-specific equivalent of a nutrition table.
• Ingredient list — including “Other Ingredients,” listed in descending order of predominance.
• Name and place of business — of the manufacturer, packer, or distributor.
• Domestic address — your product needs a US address or phone number for consumer questions. A foreign address alone is not enough.
• Allergen declaration — major allergens (milk, egg, fish, shellfish, tree nuts, peanuts, wheat, soy, and since 2023, sesame) must be declared clearly.
• Country of origin — required on imported goods, and typically requested by Amazon.

Inside the Supplement Facts Panel

This panel is where most overseas labels fail. It is not the same as the EU nutrition declaration. Key requirements:

• Serving size and servings per container must be stated exactly as the company intends the product to be consumed.
• Dietary ingredients are listed by name and quantity per serving.
• % Daily Value must be shown for vitamins and minerals, based on US RDI values. These differ from EU NRVs, so a label built for the EU cannot simply be reused.
• Proprietary blends are allowed — you may list the total weight of a blend without disclosing each component’s amount, but each ingredient must still be named, and it is a common FDA target for scrutiny.

Claims: Where the Real Risk Lives

DSHEA gives you three claim categories to work with:

1. Health claims — a direct statement linking a nutrient to a disease. These require FDA pre-authorization or an authoritative statement, and are rare in supplements.
2. Structure/function claims — these describe how a nutrient affects normal body structure or function (for example, “supports immune health”). These are allowed without pre-approval, but they require a mandatory disclaimer: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
3. Nutrient content claims — statements like “high in” or “good source of,” which must meet defined thresholds.

What you must never do is make a disease claim — implying the product treats, prevents, or cures a disease. “Supports a healthy inflammatory response” is generally acceptable; “reduces inflammation” or “treats arthritis” is not, and can turn your supplement into an unapproved drug in the FDA’s eyes.

If your formula contains a New Dietary Ingredient (NDI) — an ingredient not marketed in the US before October 1994 — you generally must submit an NDI notification to the FDA at least 75 days before marketing. This is where many novel botanical extracts trip up.

Facility and Quality Requirements

Label compliance is only half the story. The facility that makes your product must be registered with the FDA, and must follow Current Good Manufacturing Practice (cGMP) under 21 CFR 111. As an importer, you are also subject to the Foreign Supplier Verification Program (FSVP), which makes you responsible for verifying that your overseas factory meets US standards.

When you audit an OEM partner, ask directly: Are you FDA-registered? Can you provide a recent third-party cGMP audit? Who is the US agent, and who handles the FSVP role? A factory that hesitates on these questions is a factory that will cost you money later.

The Most Common Label Mistakes

• Reusing an EU label without converting %DV to US RDI values.
• Missing the mandatory structure/function disclaimer.
• Making disease claims in marketing copy that then appear on the label.
• Omitting the allergen statement or mis-declaring “may contain.”
• Wrong or ambiguous net quantity (for example, “60 caps” without a metric equivalent where required).
• No US contact address on the label.
• Listing ingredients in the wrong order, or omitting “Other Ingredients.”
• Skipping the NDI notification for a novel ingredient.

A Practical Pre-Print Checklist

1. Confirm US RDI values for every vitamin and mineral in the formula.
2. Draft the Supplement Facts panel before final artwork — never after.
3. Validate every claim against DSHEA and the FTC’s substantiation standard.
4. Confirm allergen and country-of-origin statements.
5. Verify the facility is FDA-registered and cGMP-compliant.
6. Have a US-based regulatory reviewer sign off before mass printing.

Getting the label right the first time is far cheaper than a detained shipment, a recall, or an Amazon listing suspension. The best OEM partners treat labeling as a compliance service, not a printing task — and they will tell you when your claim is a risk before you ever ship.

If you are developing a supplement for the US market and want a factory that understands DSHEA labeling from the ground up, reach out and let’s talk through your formula.

Contact:
Email: Wade@zuoningbio.com
Phone/WhatsApp: +86 187 5469 6289
Web: www.zuoningbio.com