FDA Stories #014 — A Polish Frozen Pierogi Manufacturer Had No Allergen Declaration. At All.

A trading company in Dubai imported bulk spice blends from a manufacturer in Rajasthan, India. In Dubai, they repackaged the spices into retail-sized containers, applied their own brand label, and exported to the United States. The label said 'Product of UAE.'

The product was not a product of the UAE.

The rule

Under 19 CFR Part 134, the country of origin is the country where the product was manufactured or where the last substantial transformation occurred. Repackaging — transferring a product from bulk bags into smaller retail containers — is not substantial transformation. The spices were grown, processed, and blended in India. Putting them into smaller bags in Dubai does not change the country of origin. The correct marking was 'Product of India,' regardless of where the repackaging occurred.

US Customs and Border Protection enforces country of origin marking, and the penalties are real: a 10 percent ad valorem marking duty on improperly marked goods, plus the cost of re-marking or re-labeling the entire shipment before it can be released.

The additional problem

The Indian manufacturer had an FDA food facility registration. The Dubai repackaging facility did not — and it needed one, because it was packing food for US consumption. Additionally, the Dubai facility's label used the Indian manufacturer's FDA registration number, which was incorrect because the registration number identifies a specific facility, and the repackaging was happening at a different facility.

We registered the Dubai facility with the FDA, obtained a DUNS number for the Dubai operation, corrected the country of origin to 'Product of India,' and updated the FDA registration number on the label to reflect the repackaging facility. The Indian manufacturer's registration remained active for their facility — both registrations were needed because both facilities were involved in preparing the product for US sale.

The lesson

If you buy products from one country, repackage them in another, and export to the US — the country of origin is where the product was made, not where it was repackaged. And both facilities may need FDA registration. This is especially common in Dubai, Singapore, Hong Kong, and other trading hubs. If your supply chain crosses borders, make sure every facility is registered and every label is marked correctly. fdabridge.com/contact.