The short answer
Superfood powders — moringa, matcha, spirulina, baobab, protein blends — can be sold as a conventional food or as a dietary supplement. FDA registration is needed either way, but the label, claims and manufacturing rules are different. Decide first.
| Requirement | What it means | Who |
|---|---|---|
| FDA food facility registration | Every facility that makes, packs or holds the food for the US registers with FDA and renews every two years (Oct–Dec of even years) | Your facility |
| U.S. Agent | Foreign facilities name a U.S. Agent on the registration | Your facility |
| FDA-compliant label | English label, ingredients, Nutrition Facts, allergens, net quantity, responsible business | Your facility / brand |
| Food or supplement decision | Decides the label panel, claims and manufacturing rules | Your brand |
| Prior Notice | Filed with FDA before every shipment arrives | Exporter, importer, broker or Orionex |
| FSVP | The US importer verifies your food safety | FSVP importer (your buyer or Orionex) |
Food or dietary supplement?
| Conventional food | Dietary supplement | |
|---|---|---|
| Label panel | Nutrition Facts | Supplement Facts |
| Name | Common name (e.g. “moringa leaf powder”) | Must include “dietary supplement” |
| Typical use | Added to drinks, smoothies, baking | Measured daily serving, capsules or scoop |
| Claims | Authorized health and nutrient content claims only | Structure/function claims with disclaimer and FDA notification |
| New ingredients | Must be safe and lawful for food use (e.g. GRAS) | New dietary ingredients may need an NDI notification |
By law, a dietary supplement must be labeled as one and must not be represented as a conventional food. FDA's guidance on liquid supplements and beverages shows how labeling, marketing and serving directions are used to tell the two apart — the same thinking helps with powders.
Claims: where most problems start
- No disease claims — “cures diabetes”, “fights cancer” or “lowers blood pressure” turn a product into an unapproved drug.
- “Superfood” is a marketing word, not a defined claim — it does not allow health claims.
- Supplements may say things like “supports energy” (structure/function) with the required FDA disclaimer and a notification to FDA within 30 days of first marketing.
Contaminants and quality
- Heavy metals (lead, cadmium, arsenic) — leaf and algae powders can absorb them from soil and water. Test and keep results.
- Microbiology — Salmonella in dried leaf powders is a known risk; use a validated control step.
- Pesticide residues within US tolerances.
Example
A moringa producer in India sells two products. The 200 g pouch “Moringa Leaf Powder — add a teaspoon to smoothies” is a food with Nutrition Facts. The 60-capsule bottle is labeled “Moringa — Dietary Supplement” with Supplement Facts and a structure/function claim plus the FDA disclaimer. Both come from a registered facility with a U.S. Agent, and both are tested for lead and Salmonella.
Step by step: getting your superfood powders into the US
- 1Register your facility with FDAEvery facility that makes, packs or holds the product for the US registers, and renews between October 1 and December 31 of each even-numbered year. Foreign facilities name a U.S. Agent.
- 2Make the label US-readyEnglish text, the right name, ingredients, the correct facts panel, allergens, net quantity and the responsible business — plus the product-specific points above.
- 3Agree the import roles with your buyerWho is the importer of record, who is the FSVP importer, and which customs broker files the entry. See who does what.
- 4Send your food safety documentsYour FSVP importer needs evidence that hazards are controlled — food safety plan, certificates, test results.
- 5File Prior Notice for every shipmentFDA must receive it before arrival — at least 8 hours by sea, 4 hours by air or rail, and 2 hours by road.
Checklist
- Decide: conventional food or dietary supplement — before designing the label
- FDA registration and U.S. Agent in place
- Correct panel (Nutrition Facts or Supplement Facts) and name
- No disease claims; supplement claims with disclaimer and FDA notification
- Heavy metals, microbiology and pesticides tested
- Prior Notice for every shipment; FSVP documents for your importer
Tell us your product — we send your US requirements in writing, free.
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP importer service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
Frequently asked questions
Is moringa powder a food or a dietary supplement?
It can be either. The way you label and market it decides: as a food ingredient (for example to add to smoothies) it carries Nutrition Facts; as a dietary supplement it must be labeled as a dietary supplement, carry Supplement Facts and follow supplement rules.
Do both need FDA registration?
Yes. Facilities that make, pack or hold foods or dietary supplements for the US must register with FDA and, if foreign, name a U.S. Agent.
Can I make health claims for superfood powders?
Disease claims are not allowed for either foods or supplements. Supplements may carry structure/function claims with the required disclaimer and an FDA notification. Foods may use authorized health and nutrient content claims only.
Does FDA set limits for heavy metals in powders?
There are no general FDA limits for every powder, but FDA can act against food that contains harmful levels of contaminants. Test for lead and other heavy metals — buyers often ask for results.
Who files Prior Notice for my shipments?
Anyone with the required information can file it — the exporter, the US importer, the customs broker or a consultant such as Orionex. It must reach FDA before the shipment arrives: at least 8 hours by sea, 4 hours by air or rail and 2 hours by road.
Sources
- FDA — Registration of Food Facilities and Other Submissions
- FDA — Prior Notice of Imported Foods
- FDA — FSVP Final Rule At-A-Glance
- FDA — Import Alerts (search by product, country and firm)
- FDA — Questions and Answers on Dietary Supplements
- FDA — Guidance: Distinguishing Liquid Dietary Supplements from Beverages (January 2014)
Dates, fees and regulation numbers checked against FDA and Federal Register sources on November 8, 2026. This article is general information, not legal advice.