--- title: Dietary Supplements — US Compliance & FDA Requirements type: article created: '2026-04-05' updated: '2026-04-05' source_docs: - raw/2025-10-14-la-natura-usa-call-93934348.md tags: - fda - dietary-supplements - labeling - allergens - structure-function-claims - factory-registration - us-market-entry - food-beverage layer: 2 client_source: null industry_context: food-beverage transferable: true --- # 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 [[wiki/clients/la-natura/_index|La Natura]]. 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 [[wiki/clients/ffgrono/_index|Grono]] when registering their facility as a foreign food manufacturer. --- ## Summary of Common Issues Found in Label Reviews | Issue | Status | Action Required | |---|---|---| | Collagen allergen declaration | Conditional | Verify with supplier; add "Contains: Milk" if milk protein present | | Structure/function disclaimer missing | Required | Add mandatory FDA disclaimer to all labels | | Spelling errors | Minor | Proofread all label copy before final submission | | Supplement Facts format | ✓ Correct | No action needed | | Dual declaration method | ✓ Correct | No action needed | | DV notation for ingredients without established DVs | ✓ Correct | No action needed | --- ## Related - [[wiki/clients/la-natura/_index|La Natura]] — client for whom this review was conducted - [[wiki/clients/ffgrono/_index|FF Grono]] — prior precedent for foreign manufacturer registration - [[wiki/knowledge/food-beverage/us-market-entry-overview|US Market Entry — Food & Beverage Overview]] (if exists)