The short answer
Sesame became a major food allergen in the U.S. on January 1, 2023, and tahini has been linked to Salmonella outbreaks. Allergen labeling and Salmonella control are the two big issues.
What exporters should watch for
⚠️ The 9th major allergen
Since January 1, 2023, sesame must be declared like milk or peanuts. Some U.S. makers added sesame to products to avoid cross-contact claims, so clear labeling matters for exporters too.
🦠 Salmonella
Tahini and sesame paste are eaten without cooking, and several producers have been placed on FDA import alert after Salmonella findings. Roasting controls and environmental monitoring are essential.
🏭 Registration
Seed cleaners, roasters and tahini or halva makers register with FDA and name a U.S. Agent. Each shipment needs Prior Notice.
🏷️ Halva and spreads
Halva often contains pistachios or other nuts, which must be declared as tree nuts. Labels need U.S. Nutrition Facts and net weight in ounces and grams.
Common reasons shipments are stopped
- Salmonella in tahini or seeds
- Sesame not declared as an allergen
- Undeclared nuts in halva
- Unregistered facility
- No FSVP at the U.S. importer
🏢 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
When did sesame become a major allergen in the U.S.?
On January 1, 2023, under the FASTER Act. Sesame must now be declared in the ingredient list or a “Contains” statement, like the other eight major allergens.
Why is tahini on FDA import alert?
Several tahini and sesame paste producers have had Salmonella in their products. FDA places such firms on import alert so their shipments are detained until they show the problem is fixed.
Do tahini makers need FDA registration?
Yes. Facilities that make, pack or store tahini for the U.S. must register with FDA, name a U.S. Agent and file Prior Notice for each shipment.
Sources
- FDA — Food allergies: what you need to know (sesame as the 9th major allergen)
- 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.