U.S. Dietary Supplement Import Requirements — NDI, CGMP, Supplement Facts
Under DSHEA (1994), dietary supplements are classified as 'food' in the U.S., so there's no FDA premarket approval — but several easy-to-miss notification duties stack up: NDI, Structure/Function Claims, SAE reporting, and more. It's not the ingredient but the wording on the label that draws the line between food, supplement, and drug.
Requirements Specific to This Category
DSHEA Basics — No Premarket Approval, But Notification Still Applies
DSHEA (Dietary Supplement Health and Education Act, 1994) is the foundation of U.S. dietary supplement regulation. Two core principles: ① supplements are classified as food, not drugs. ② manufacturers and importers get no FDA premarket approval — instead of proving safety in advance, the structure requires FDA to prove a product is unsafe before it can be pulled from the market. The most common misunderstanding arises right here: mistaking 'no premarket approval' for 'nothing to notify FDA about.' In reality there are several mandatory notification steps — facility registration (FFR), NDI notification, the 30-day Structure/Function Claim notification, and SAE reporting. To qualify as a dietary supplement, the product must be intended to supplement the diet, must not be represented as a conventional food or sole item of a meal, and must be labeled 'Dietary Supplement.'
Food vs. Supplement vs. Drug — Wording Draws the Line
The exact same ingredient can shift categories based purely on label wording. "Calcium supports bone health" is a valid Structure/Function Claim and stays within supplement territory (subject to 30-day notification). The moment a claim like "helps prevent osteoporosis" implies disease prevention or treatment, the product is reclassified as an unapproved drug (requiring an NDA/ANDA), which can lead to automatic detention, a sales ban, a warning letter, and in the worst case criminal liability. The most common cause of trouble is translating language already approved for a Korean 'health functional food' certification directly into English — Korea's MFDS standards and FDA's standards are not the same.
Food Facility Registration + Prior Notice (Same as Food)
Because supplements are food, FFR (facility registration), U.S. Agent, Prior Notice, and FSVP all apply exactly as described under the Food category above. That said, supplements are exempt from FSMA's Preventive Controls obligation as long as they comply with 21 CFR Part 111 (CGMP) and meet SAE reporting requirements — but that exemption only covers preventive controls, not FFR, FSVP, or recordkeeping. FSVP itself isn't exempt for supplements; instead, a separate provision (21 CFR §1.511) applies — the hazard analysis and verification activity shift focus away from individual hazards and toward confirming that the supplier complies with 21 CFR Part 111 (CGMP). Reusing a generic food-FSVP template commonly omits this CGMP-compliance check and gets flagged in an audit — request a CGMP audit report or a third-party CGMP certificate (e.g., NSF, USP) from the supplier and keep it on file.
Ingredient Classification — Old Dietary Ingredient vs. NDI
The cutoff date is October 15, 1994 (when DSHEA took effect). An ingredient used in the U.S. supplement market before that date is an Old Dietary Ingredient (no notification required). An ingredient introduced afterward — or an existing ingredient made through a new manufacturing method, form, extract, combination, or concentrate — is treated as a New Dietary Ingredient (NDI, notification required). Vitamins A, B, C, D, E, K; basic minerals like calcium and magnesium; fish oil (omega-3); and glucosamine are generally Old. By contrast, specific probiotic strains (judged at the strain level!), plant ingredients made with novel extraction methods, and nano-form ingredients are more likely to be NDIs. Even long-used Korean ingredients such as red ginseng and ginseng can be classified as NDIs under U.S. supplement-market standards if they're a specific, standardized extract — don't assume something is Old just because the strain name sounds familiar; when in doubt, treat it as an NDI.
NDI Notification — File at Least 75 Days Before Launch
A supplement containing an NDI must submit safety evidence to FDA at least 75 days before U.S. launch (21 CFR §190.6). This isn't an 'approval' process — it's structured so that if FDA raises no objection within 75 days, you may proceed to launch; if FDA does object, launch must be held. Required content: the NDI's precise name and structure, product description, dosage and conditions of use, safety evidence (history of use, toxicology studies, clinical studies, peer-reviewed literature), and supplier information. In practice, plan for 90–120 days of lead time rather than the bare 75.
CGMP (21 CFR Part 111) — A Shared Duty of Manufacturer and Importer
Current Good Manufacturing Practice, effective 2007, applies to every facility that manufactures or imports supplements. Its core purpose is ensuring the finished product actually delivers the ingredients and amounts stated on the label — it covers five areas: personnel, physical plant and equipment, production and process controls (master manufacturing records, batch production records), quality control (raw-material and finished-product testing), and recordkeeping (1 year past shelf life, or 2 years after final manufacture if no shelf life is stated). Importers are responsible for independently verifying a foreign supplier's CGMP compliance — a supplier's self-attestation alone isn't enough; you need to obtain and retain a third-party audit report or GMP certificate.
Structure/Function Claims — Disclaimer Plus Notification Within 30 Days of Launch
A statement describing how a nutrient or ingredient affects the body's structure or function (e.g., "Supports the immune system," "Helps maintain healthy bones") carries two simultaneous obligations. ① Display the disclaimer 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." (FDA-mandated wording — do not alter it — placed prominently on the same page as the claim.) ② Notify FDA in writing within 30 days after the product launches (21 CFR §101.93) — this is a post-launch notification, not a preapproval. Don't cross the line between 'treats/prevents disease' and 'supports structure/function': "Controls diabetes," "Treats anxiety disorder," "Relieves arthritis pain," "Lowers cholesterol," and "Prevents Alzheimer's disease" are all prohibited, while "Supports healthy blood sugar levels," "Promotes relaxation," "Supports joint comfort," "Helps maintain healthy cholesterol," and "Supports cognitive function" sit at roughly the acceptable boundary. This rule applies equally to websites, social media, and catalogs — all marketing material counts as 'labeling,' not just the physical label.
SAE Reporting Requirement + a U.S. Contact on the Label Is Mandatory
When a serious adverse event (SAE — death, life-threatening condition, hospitalization or a prolonged one, permanent disability, birth defect, etc.) occurs, the Responsible Person (the manufacturer, packer, or distributor named on the label) must gather information immediately upon receipt and report it to FDA within 15 days via MedWatch Form 3500A (per the 2007 consumer protection act). Records must be kept for 6 years. The matching requirement is a U.S. contact on the label (FD&C Act §403(y)) — a U.S. domestic address or phone number must be printed somewhere on the label; a Korean address or an overseas-only contact is, by itself, grounds for a misbranding finding that blocks import. A foreign manufacturer with no U.S. entity must designate a U.S. importer or distributor as the Responsible Person and put that party's contact information on the label.
Supplement Facts Panel — A Distinct Format From Nutrition Facts
Nutrition information on a supplement label is titled 'Supplement Facts,' and it's governed by a different regulation (21 CFR §101.36) than ordinary food's 'Nutrition Facts' (21 CFR §101.9). Required elements: Serving Size, Servings Per Container, Amount Per Serving, %Daily Value (where applicable), and a Dietary Ingredients list. For ingredients with an established RDI/DRV (e.g., vitamin C, zinc), show the %DV; for those without one (herbal extracts, probiotic strains, etc.), show only the amount and mark the %DV column with '†Daily Value not established.' Botanical ingredients must include the Latin name and the plant part used (fruit/root/leaf/ bark, etc.) — for example, 'Red Ginseng Extract' alone isn't sufficient; it needs the Latin name and part, like 'Panax ginseng (root).' A Proprietary Blend of multiple ingredients can withhold individual amounts, but must show the total weight and list components in descending order by weight. Font size, weight, spacing, and rule lines for the panel are all specified in detail under 21 CFR §101.36(e) — a freely designed panel will typically fail the format requirements.
Requirements Common to All FDA-Regulated Goods
Entry Filing (via CBP/ACE)
Every import shipment is filed with U.S. Customs and Border Protection (CBP) through the ACE/ABI system. FDA-regulated goods are electronically filed with FDA at the same time, and the PREDICT risk-screening system reviews them automatically. This is typically handled by a customs broker.
Confirm the FDA Product Code
FDA assigns every regulated item a unique product code (industry–class–subclass–PIC). An accurate code is required at entry filing; an incorrect one causes review delays and misclassification. Look up or build the code with the FDA Product Code Builder.
Check Import Alerts in Advance — DWPE Risk
Specific countries, manufacturers, or products can appear on an Import Alert and become subject to Detention Without Physical Examination (DWPE) — an automatic hold with no inspection. Alerts come in three tiers: Red List (automatic detention), Yellow List (conditional detention), and Green List (exempted). A single violation can trigger listing, and suppliers rarely disclose it proactively. Search by company name + address + country + product every time before shipping. Once listed, how you respond in the first 24 hours determines whether recovery takes 6 months or several years — waiting it out or sending only export-country paperwork does not work; you need to engage FDA's compliance staff directly through the formal process. Searchable in this tool's 'Live Lookup' tab.
💡 Practical Tips
- Even red ginseng and vitamins can end up detained for unapproved drug claims if the label says something like 'effective against disease.'
- 'Boosts immunity' has to become 'Supports immune system' (with a disclaimer and 30-day notification) — phrases like 'relieves fatigue,' 'improves blood circulation,' 'detoxifies,' and 'improves liver function' are flatly prohibited in the U.S.
- Probiotics must have their Old/NDI status determined at the strain level — the same species name doesn't guarantee the same classification; a specific strain can still be an NDI.
- If the label has no U.S. contact (address or phone number), the product is misbranded and import is blocked no matter how perfect everything else is.
- The Supplement Facts panel is a matter of regulation, not design — components like the EPA/DHA inside fish oil must be indented as sub-ingredients, among other formatting rules.
📋 Quick Reference Table
| Item | Description | Basis | Notes |
|---|---|---|---|
| Definition | Vitamins, minerals, herbs, etc. intended to supplement the diet | DSHEA 1994, 21 USC §321(ff) | Classified as food |
| FDA premarket approval | Not required — the company bears responsibility for safety | DSHEA | Separate notification duties still apply |
| Facility registration (FFR) | For facilities that manufacture/hold supplements sold in the U.S. | 21 CFR Part 1 | Renew every 2 years |
| NDI notification | For new ingredients introduced after 10/15/1994 | 21 CFR Part 190 | File 75 days before launch |
| CGMP | Standard covering manufacturing, packaging, and labeling | 21 CFR Part 111 | Effective since 2007 |
| S/F Claim notification | When using a Structure/Function Claim | 21 CFR §101.93 | Within 30 days of launch |
| Disclaimer | Required on the label whenever an S/F Claim is used | 21 CFR §101.93 | Must use FDA's exact prescribed wording |
| SAE reporting | When a Serious Adverse Event occurs | FD&C Act §761 | Report within 15 days |
| SAE recordkeeping | All SAE-related records | FD&C Act §761(e) | 6 years |
| U.S. contact | U.S. address or phone number shown on the label | FD&C Act §403(y) | Missing it means misbranded |
| Supplement Facts | The nutrition information panel for supplement labels | 21 CFR §101.36 | Distinct from Nutrition Facts |
| FSVP | The importer's Foreign Supplier Verification Program | 21 CFR Part 1 Subpart L | Applies to supplements too |
🗣️ Allowed / Prohibited Claim Glossary
⚡ Related Real-World Cases
- Red Ginseng Concentrate — a Structure/Function Claim Violation — Missing Disclaimer + Prohibited Wording
- Probiotics — No NDI Notification — Mistaking a New Strain for an Old One
- Collagen Drink — Classified as a Drug — The 'Skin Regeneration' Claim
- Omega-3 Capsules — a Supplement Facts Formatting Error — How EPA/DHA Content Should Be Displayed
- Multivitamin — Missing SAE Contact on the Label — There Was No U.S. Contact
- Dietary Supplement Ingredient — Mistaking §1.511 for §1.502 — Applying Standard Food FSVP to a Supplement — a Structural Error