Dietary Supplements — US Compliance & FDA Requirements

This article captures FDA requirements for dietary supplement products entering the US market, drawn from a compliance review conducted for ^[1]. The requirements below apply broadly to any foreign manufacturer selling dietary supplements in the US.

Label Compliance Checklist

What's Required

• Supplement Facts panel — mandatory format for all dietary supplements (distinct from Nutrition Facts used for conventional food)
• Dual declaration method — active ingredients listed in the Supplement Facts panel; other ingredients (e.g., carriers, excipients) listed separately under "Other Ingredients"
• Daily Values (DVs) — vitamins and minerals with established DVs must be listed with percentage; ingredients without established DVs (e.g., turmeric extract, collagen) must be listed with a dagger symbol (†) indicating "Daily Value not established"
• Structure/function claim disclaimer — required whenever a structure/function claim appears anywhere on the label, including in the product name (see below)
• Allergen declarations — required for all major food allergens present in any ingredient, including residual protein (see below)
• Accurate spelling — label copy should be proofread carefully; errors noted during review are a compliance flag

Allergen Labeling — Collagen Edge Case

Collagen is typically derived from bovine hides or bones and is not itself a major food allergen. However:

If the collagen hydrolysate contains any detectable protein derived from milk, then milk must be declared as an allergen.

Practical implication: Bovine collagen suppliers should be asked explicitly whether their product specification lists any milk protein content. If the supplier's spec sheet is silent on allergens, that is generally a strong indicator that none are present — but written confirmation is best practice.

If no milk protein is present → no allergen statement required for collagen.
If milk protein is present → a "Contains: Milk" statement must appear on the label.

Structure/Function Claims & Mandatory Disclaimer

What Counts as a Structure/Function Claim

The FDA treats any language that characterizes the role of a nutrient or ingredient in affecting the structure or function of the body as a structure/function claim. This includes:

• Explicit claims on the label (e.g., "supports immune health")
• Product names themselves — e.g., "Cellular Support Coffee" or "Wellness Support" are considered claims by the FDA

Mandatory Disclaimer

Whenever a structure/function claim is made, the following disclaimer must appear on the label:

"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."

The disclaimer is commonly rendered in small print but must be present. Omitting it — even when the claim appears only in the product name — is a compliance violation.

FDA Notification Requirement

• The manufacturer must notify the FDA within 30 days of first marketing a product bearing structure/function claims.
• Best practice: submit notification before the first shipment arrives in the US to avoid delays or complications at the border.
• The FDA may respond requesting changes to specific claims; any required changes would apply to future production runs, not existing inventory.

Foreign Manufacturer Registration

Any facility outside the US that manufactures dietary supplements for the US market must be registered with the FDA as a foreign supplement manufacturer. This is a separate requirement from food facility registration (though the process is similar).

Registration Process

1. Gather the following facility details:
   - Factory name and address
   - Name of the facility manager
   - Phone number and contact information
2. Submit registration to the FDA (handled by the US-side regulatory contact or agent)
3. Be prepared for the possibility of an inspection — for European facilities, this would typically be coordinated through the US embassy

Existing Certifications

International certifications such as HACCP and IFS are globally recognized and support a facility's compliance posture. However, the FDA may additionally require evidence that the facility is certified or authorized to produce dietary supplements specifically (as distinct from conventional food). This certificate should be obtained from the relevant national health authority (e.g., Ministry of Health) before registration is submitted.

Precedent: This same foreign manufacturer registration process was completed previously for ^[2] when registering their facility as a foreign food manufacturer.

Summary of Common Issues Found in Label Reviews

Related

• ^[1] — client for whom this review was conducted
• ^[3] — prior precedent for foreign manufacturer registration
• ^[4] (if exists)