FDA故事 #013 — 中国保健品工厂的成分在中国合法但被FDA禁止

A family-owned food company in Kraków made frozen pierogis — traditional Polish dumplings filled with potato and cheese, meat, and sauerkraut. They had been exporting to Polish diaspora communities in Chicago and New York through a small specialty importer. The product was beloved. Five-star reviews. Repeat orders every month.

Then the importer's new compliance consultant reviewed the label. What he found stopped the next shipment.

The missing declaration

The ingredient list on the pierogi label correctly listed flour (wheat), eggs, cheese (milk), butter (milk), and other ingredients. Every allergen was technically named in the ingredient list. But there was no separate allergen declaration — no 'Contains: wheat, eggs, milk' statement, and no parenthetical allergen identification after each ingredient.

Under FALCPA, major allergens must be declared either in parentheses after the ingredient name or in a separate 'Contains' statement adjacent to the ingredient list. Simply including the word 'flour' in the ingredient list — without specifying that flour is derived from wheat — does not satisfy the requirement. The label was non-compliant.

Why it matters beyond the FDA

Allergen mislabeling is the number one cause of food recalls in the United States. It is also the number one cause of Class I recalls — the category reserved for situations with a reasonable probability of serious adverse health consequences or death. A consumer with a severe wheat allergy who does not see a clear allergen declaration might assume the product is safe. If they eat it and have an anaphylactic reaction, the manufacturer and importer face not only FDA enforcement but also civil liability.

We redesigned the label with a compliant 'Contains: wheat, eggs, milk' statement positioned immediately after the ingredient list in a font size no smaller than the ingredient list itself. We also added the sauerkraut filling variant, which contained no allergens beyond what was already declared, and reviewed the manufacturing process for cross-contact risks with peanuts and tree nuts from other products made in the same facility.

经验教训

If your product contains any of the nine major US allergens — milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, or sesame — the allergen must be explicitly declared on the label using the FDA-required format. Listing the ingredient by its technical name is not sufficient. This is one of the most common labeling errors we see, and one of the easiest to prevent. Send us your label at fdabridge.com/food.