I have had a shipment held by US FDA since July 2008 of our famous Novia del Sol Stuffed Olives. Why? There was an error on the commercial invoice that caused an inspector to think the olives were "low-acid".
Foods that are low acid, as most of you know, need additional information filed with FDA. Low acid is defined as foods with a pH above 4.6. Here are some links that explain:
Cornell's Low Acid Fact Sheet
or
US FDA's Fact Sheet
We have shown several compliance officers all needed documents showing that the product is NOT LOW ACID. FDA has taken samples that clearly prove these olives are NOT LOW ACID. FDA have in other ports and even in the port of LA approved prior and SUBSEQUENT shipments as NOT LOW ACID.
The FDA in So. California, long overworked, has been consolidating and moving people around between offices. As this takes place, our case has fallen through the cracks and now nobody wants to put their name to a release in this day of FDA fear of mistakes... Our shipment is lost in this twilght zone...
One officer to whom we were told to use for compliance freely admitted not having knowledge of foods but expertise in other areas, asked us for more information to add to the growing file...Then passed this hot potato to another investigator...
There is no direct dialogue between importers and compliance.
"Change" is not just political phrasing... It is real world... We all need to participate openly and honestly.
Without the proper environment to improve things, government risks being part of the problem & not the solution... If these olives held hostage are any example.
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