FDA Stories #001 — A Sicilian Olive Oil Label Was 8 Days from Being Refused at the US Border

A Sicilian family estate was 8 days away from printing labels that would have been refused at the US border.

Three generations of olive growing. Single-cultivar extra virgin olive oil from the hills of Sicily. Award-winning product. A designer who spent months getting the bottle just right.

The label looked beautiful. It had serious problems.

What we found

The net quantity on the front label was missing the 'Net' prefix, listed metric before the US unit, and was merged onto the same line as the country of origin. Three federal labeling violations — in one field.

The back label said '16.9 oz' instead of '16.9 fl oz.' One missing word. Weight is not volume. Under FDA rules, that is a misbranding violation.

The Italian VAT number was printed on the US version of the label. No FDA relevance. It had to come off.

Then came the near-miss no one saw coming

During the second revision, the wrong back label file was submitted. The front label said one product name. The back label said something else entirely.

Two different product names on the same label is misbranding under 21 U.S.C. § 343. Had that file gone to the printer and the shipment reached US Customs — refused. The refusal becomes a public record, searchable by every American importer, distributor or buyer they would ever approach.

We caught it before it happened.

3 revisions. 8 days. Final clearance issued.

The lesson

The label is the last thing most food producers think about before entering the US market. It is the first thing US Customs checks.

If you are a European food producer preparing for the US — send us your label before it goes to print. Visit fdabridge.com/food or fdabridge.com/contact.