The short answer
In the U.S., “chocolate” is not just a name — FDA has standards of identity for cocoa and chocolate products. Exporters also need to get allergens and colors right, and buyers increasingly ask about lead and cadmium.
What exporters should watch for
📏 Standards of identity
FDA sets standards for cacao products (21 CFR 163): what can be called milk chocolate, sweet chocolate, white chocolate or cocoa, including minimum cacao and milk content. A product that doesn’t meet the standard needs a different name such as “chocolate flavored”.
🥛 Allergens
Milk, soy, tree nuts, peanuts, wheat, egg and sesame must be declared under U.S. rules. Shared-line cross-contact should be controlled and, where needed, disclosed.
🎨 Colors and Red No. 3
Coatings and decorations may use only FDA-approved colors. FD&C Red No. 3 (erythrosine) is banned in U.S. food from January 15, 2027.
⚖️ Heavy metals
Cocoa can contain cadmium and lead. FDA has no specific limit for chocolate, but U.S. buyers increasingly ask for test results, and some states have their own warning rules.
Common reasons shipments are stopped
- Wrong product name under the chocolate standards
- Undeclared allergens — milk, nuts, soy, sesame
- Unapproved colors or Red No. 3 after January 2027
- Labeling — EU nutrition panel, metric-only weights
- Facility not registered or no Prior Notice
🏢 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.
What you need to register — and what it costs
| Product type | FDA requirement | Orionex price |
|---|---|---|
| Food, beverages, supplements | Food facility registration + U.S. Agent, renewed every 2 years; Prior Notice for each shipment | $300/year or $450 for 2 years |
| Cosmetics | MoCRA facility registration (every 2 years) + product listing + U.S. Agent | $300/year or $450 for 2 years; listing $150/product |
| Medical devices | Establishment registration (yearly, FDA fee paid separately) + device listing; 510(k) for many Class II devices | $550/year; listing $50/device |
| Drugs (incl. OTC) | Drug establishment registration (yearly) + NDC labeler code + drug listing | $550/year; listing $350/product |
Every Orionex registration includes the U.S. Agent service, D-U-N-S number set-up where needed and a Certificate of Registration. All prices →
Tell us your product — we’ll confirm what FDA requires, in writing, by email.
Frequently asked questions
Can I call my product “milk chocolate” in the U.S.?
Only if it meets FDA’s standard of identity for milk chocolate in 21 CFR 163, including minimum chocolate liquor and milk solids content and permitted ingredients. Products that use other fats or less cacao must use a different name, such as “milk chocolate flavored”.
Does FDA limit lead in chocolate?
FDA has not set a specific action level for lead in chocolate, but adulteration rules apply and FDA monitors toxic elements. In practice, U.S. importers often require cadmium and lead testing, so test results help sales.
Sources
- eCFR — 21 CFR Part 163, Cacao products
- FDA — Import Alerts by Publish Date
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.