Short answer: FDA placed VitaNuts Kunafa Pistachio Filling products from Pista Fistik Gida Imalat Ic ve Dis Ticaret Limited Sirketi in Gaziantep, Türkiye, on Import Alert 99-22 because the labels failed to declare wheat. The labels named kunefe as an ingredient, but wheat was present as one of its sub-ingredients.
This article summarizes a public FDA import-alert entry dated December 5, 2025. The company named in the record is not identified as an FDABridge client, and the entry does not state that illnesses occurred.
How did wheat disappear from the pistachio filling label?
FDA's entry covers VitaNuts Kunafa Pistachio Filling and a mint variant described as pistachio paste or pistachio spread. According to the alert, the ingredient statement declared kunefe, but it did not declare wheat as a sub-ingredient of the kunefe. FDA therefore said the products appeared misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act.
This is a classic compound-ingredient failure. A finished-food manufacturer may receive pastry, biscuit, chocolate, seasoning, flavor, sauce, or filling from another supplier and list only the familiar component name. But the US label still needs an accurate declaration of the ingredients inside that component and a clear declaration of any major food allergen, subject to the applicable labeling rules and limited exceptions.
Why is a familiar regional ingredient name not enough?
A US consumer may not know that kunefe or kunafa commonly contains wheat-based pastry. More importantly, allergen disclosure does not depend on what a consumer might infer from a traditional product name. The label must identify the food source of a major allergen in the manner required by US law.
FDA's alert says the listed articles are subject to refusal of admission under section 801(a)(3). Because Import Alert 99-22 authorizes detention without physical examination, the issue can affect shipments before any retail sale. Registration, Prior Notice, and an importer relationship do not cure an inaccurate allergen declaration.
How should exporters review compound ingredients?
- Obtain a complete, current sub-ingredient statement from every supplier rather than relying on the component's trade name.
- Map each sub-ingredient against the nine US major food allergens and confirm the source species or grain where required.
- Reconcile the formula, supplier specification, allergen matrix, production record, and final artwork before release.
- Review both parenthetical ingredient declarations and any separate Contains statement for consistency.
- Trigger a new label assessment whenever a supplier changes a premix, pastry, flavor, or processing aid.
Quick answers for Turkish food exporters
Can a label list only kunefe without naming wheat?
Not when wheat is a sub-ingredient that must be declared. A traditional or commercial component name does not replace the required ingredient and allergen information.
Can FDA detain a product even when no allergic reaction was reported?
Yes. FDA can act on an apparently misbranded label without waiting for an illness or injury report.
Verified public sources
- FDA Import Alert 99-22, including the Pista Fistik Gida entries: https://www.accessdata.fda.gov/CMS_IA/importalert_561.html
- FDA guidance on food allergies and major food allergens: https://www.fda.gov/food/food-labeling-nutrition/food-allergies
FDABridge reviews US ingredient statements, allergen declarations, Nutrition Facts panels, facility registration, and shipment readiness. Visit fdabridge.com/food or fdabridge.com/contact.
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