Exporting dietary supplements to the US: FDA rules, NDI and labels

FDA does not approve dietary supplements before they are sold, but that does not mean there are no rules. The facility that makes, packs or holds them registers with FDA, each shipment needs prior notice, an ingredient not marketed in the US before 15 October 1994 needs a notification at least 75 days before sale, and the label and any claims must follow FDA's supplement rules.

Checked against official sources: 2026-10

At a glance

Pre-approvalNone: under DSHEA, FDA cannot approve dietary supplements before they are marketed

ResponsibilityManufacturers and distributors are responsible for safety and for products not being adulterated or misbranded

Facility registrationRequired before manufacturing, packaging or holding supplements for the US (Bioterrorism Act)

New dietary ingredientNot marketed in the US before 15 October 1994: notify FDA at least 75 days before sale (21 CFR 190.6)

Structure/function claimNotify FDA no later than 30 days after first marketing, and print the required disclaimer (21 CFR 101.93)

Label"Dietary supplement" statement of identity, Supplement Facts panel, net quantity, name and place of business

Disease claimsA product claiming to diagnose, treat, cure or prevent a disease is treated as a drug

Adverse eventsManufacturers and distributors record, investigate and forward serious adverse event reports to FDA

What FDA requires instead of approval

Under the Dietary Supplement Health and Education Act (DSHEA), FDA does not have the authority to approve dietary supplements before they are marketed. Manufacturers and distributors carry the initial responsibility for making sure their products are safe, are not adulterated and are labeled correctly, and they must follow current good manufacturing practices. Facilities that manufacture, pack or hold supplements for the US register with FDA before they start, as food facilities do, and imported shipments need FDA prior notice like other food.

A new dietary ingredient is one that was not marketed in the US before 15 October 1994. A supplement containing one that has not been present in the food supply as an article used for food, in a form that has not been chemically altered, needs a premarket notification to FDA at least 75 days before it is introduced into interstate commerce, with the basis for concluding it will reasonably be expected to be safe. The 75 days run from the filing date FDA gives, and a substantive amendment starts them again.

Label elements for a US supplement

Statement of identity: the product name and the words "dietary supplement" or an equivalent term
Supplement Facts panel (nutrition labeling for supplements)
Net quantity of contents
Name and place of business of the manufacturer, packer or distributor
The disclaimer under any structure/function statement
Structure/function statements only, never claims to diagnose, treat, cure or prevent a disease

Claims and safety reporting

A structure/function statement describes how a nutrient or ingredient affects the body's structure or function. The firm must notify FDA no later than 30 days after first marketing a supplement that carries one, and the label must carry the disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." A claim that the product diagnoses, treats, cures or prevents a disease makes it a drug in FDA's eyes, unless it is an authorized health claim the product qualifies for.

After sale, manufacturers and distributors must record, investigate and forward to FDA any reports of serious adverse events they receive. Products that appear to break FDA rules can be detained when they arrive, so check FDA's import alerts for your product type before shipping.

Step by step

Check each ingredient: if it was not marketed in the US before 15 October 1994, file a new dietary ingredient notification at least 75 days before sale.
Register the manufacturing or packing facility with FDA and appoint a US agent if it is abroad.
Design a US label with the statement of identity, Supplement Facts panel, net quantity and the name and place of business.
Review every claim: keep structure/function statements, add the disclaimer, and notify FDA within 30 days of first marketing.
File FDA prior notice for each shipment and keep a system for recording and forwarding serious adverse events.

Documents you usually need

FDA food facility registration number
New dietary ingredient notification acknowledgment, if any ingredient needs one
Final US label with Supplement Facts panel
Structure/function claim notification sent to FDA
Prior notice confirmation and commercial invoice for each shipment

Common problems and how to avoid them

The label says the product treats or prevents a disease.

What to do: Remove disease claims; they make the product a drug. Use structure/function wording with the required disclaimer.

A new ingredient is shipped without a notification.

What to do: File the new dietary ingredient notification and wait 75 days from the filing date before selling.

The label uses a Nutrition Facts panel or no panel at all.

What to do: Use a Supplement Facts panel, as FDA requires for dietary supplements.

The structure/function claim was never notified to FDA.

What to do: Notify FDA no later than 30 days after first marketing the product with that claim.

Sources

Questions and Answers on Dietary Supplements U.S. Food and Drug Administration (FDA)
21 CFR 190.6: Requirement for premarket notification Electronic Code of Federal Regulations (eCFR)
21 CFR 101.93: Certain types of statements for dietary supplements Electronic Code of Federal Regulations (eCFR)

Rules change often. This note is practical guidance based on the sources above, not legal advice. Confirm current requirements with the authority, your importer or a licensed customs broker before you ship.

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Common questions

Does FDA approve dietary supplements before they are sold?

No. Under DSHEA, FDA does not approve supplements before marketing; manufacturers and distributors are responsible for their safety and labeling.

What is a new dietary ingredient?

An ingredient not marketed in the US before 15 October 1994. Some need a notification to FDA at least 75 days before the supplement is sold.

What disclaimer is needed for a structure/function claim?

"This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

Do supplement factories abroad need FDA registration?

Yes. Facilities that manufacture, pack or hold supplements for the US register with FDA before they start, and shipments need prior notice.

Can a supplement label say it treats a disease?

No. A disease claim makes the product a drug in FDA's eyes, unless it is an authorized health claim the product qualifies for.

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