The short answer
Candy, chocolate and gummies face three US-specific issues: which colors are allowed, lead, and whether a gummy is a candy or a dietary supplement.
| 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 |
| Colors and lead | US-permitted color additives only; low lead (0.1 ppm guidance for children’s candy) | Your facility |
| 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) |
Color additives: check every color
Only color additives permitted by FDA can be used in US food. The biggest change now is FD&C Red No. 3 (erythrosine): its authorization in food — including candy and supplements — ends on January 15, 2027. Read our Red No. 3 guide. Colors permitted in your home market may not be permitted in the US, so check each one, and declare them correctly on the label.
Lead in candy
FDA's guidance recommends that lead in candy likely to be eaten frequently by small children does not exceed 0.1 ppm. FDA has pointed in particular to candies with chili, tamarind or salt, and to powdered snack mixes. Test ingredients such as chili powder and tamarind, and test the finished candy.
Candy or dietary supplement?
| Candy (conventional food) | Dietary supplement gummy | |
|---|---|---|
| Label panel | Nutrition Facts | Supplement Facts |
| Name | Common name (e.g. “fruit gummies”) | Must say “dietary supplement” |
| Claims | Food claims only | Structure/function claims with the required disclaimer and FDA notification |
| Manufacturing rules | Food GMPs / preventive controls | Dietary supplement GMPs |
By law, a dietary supplement must be labeled as a dietary supplement and not be represented as a conventional food. Decide which one your product is before you design the label.
Other label points
- Allergens — milk, soy, wheat, tree nuts and peanuts are common in chocolate and confectionery; gelatin is not a major allergen but many buyers ask about its source.
- Standards of identity — names like “milk chocolate” or “white chocolate” have US definitions.
- Added sugars on the Nutrition Facts label.
Example
A confectionery maker in Türkiye exporting Turkish delight registers with FDA and names a U.S. Agent. It replaces a color not permitted in the US, declares pistachio (a tree nut) and wheat starch where used, and sells its vitamin gummies separately, labeled as dietary supplements with Supplement Facts.
Step by step: getting your confectionery 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
- FDA registration and U.S. Agent in place
- Every color permitted in the US; no Red No. 3 from January 15, 2027
- Lead tested in high-risk ingredients and finished candy
- Candy or supplement decided; correct label panel and claims
- Allergens, standards of identity and added sugars checked
- 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 Red No. 3 allowed in candy sold in the US?
Not after January 15, 2027. FDA revoked the authorization for FD&C Red No. 3 in food, including candy and dietary supplements, with that compliance date.
What lead level does FDA recommend for candy?
For candy likely to be eaten frequently by small children, FDA’s guidance recommends lead levels not exceeding 0.1 ppm. FDA has highlighted chili-, tamarind- and salt-based candies and powdered snack mixes as products of concern.
Is a vitamin gummy a candy or a dietary supplement?
It depends on how it is labeled and marketed. A dietary supplement must be labeled as a dietary supplement, carry a Supplement Facts panel and follow supplement rules; a candy carries Nutrition Facts and follows food rules. You cannot mix the two.
Do chocolate makers need anything special?
Chocolate has US standards of identity for names like “milk chocolate”. Products that do not meet the standard need a different name. Milk, soy and tree nuts are common allergens to declare.
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)
- Orionex — FD&C Red No. 3 ban (Jan 15, 2027), with FDA sources
- FDA — Guidance: Lead in Candy Likely To Be Consumed Frequently by Small Children (0.1 ppm)
- FDA — Lead in Food and Foodwares
- FDA — Questions and Answers on Dietary Supplements
- FDA — Food Allergen Labeling Guidance: Frequently Asked Questions
Dates, fees and regulation numbers checked against FDA and Federal Register sources on November 8, 2026. This article is general information, not legal advice.