Courtesy Food and Drug Administration
An Oregon juice manufacturer has received a warning letter from the U.S. Food and Drug Administration for inadequately controlling for patulin, a harmful fungal toxin.
The Hood River Juice Co., which sells apple juices and ciders under the “Ryan’s” brand, used a system of inspection and sorting that wouldn’t sufficiently limit patulin below 50 parts per billion, according to FDA.
When FDA officials inspected the company’s facility in Hood River, Ore., in late 2017, they noted that internal tests had identified three batches with patulin levels of 187, 92 and 67 parts per billion.
“Even a small percentage of rotten, moldy, and damaged apples may contain high levels of patulin to result in the finished product exceeding FDA’s action level for patulin of 50 ppb,” the warning letter said. “Any apples which are rotten, moldy, bruised or damaged should be trimmed or culled from production.”
Apples at the facility were stored “outside for extended periods without atmospheric or temperature controls in open, wooden bins,” increasing the likelihood they’d become contaminated with the toxin, the agency said.
The FDA said the Hood River Juice Co. had violated “hazard analysis and critical control points,” or HACCP, regulations by manufacturing an adulterated product.
While the company responded to the inspection by vowing to revise its HACCP plan to deal with the problem, the agency hasn’t yet received that update.
The agency also faulted the company for not properly monitoring cleanliness of food contact surfaces to prevent cross-contamination, such as leaving “clumps of apple mash on mesh press bags after cleaning” and “peeling paint with apparent black, mold-like growth on the ceiling above press bags.”
Hood River Juice Co. sent a response to FDA claiming to have corrected these problems but hasn’t provided documentation, the agency said.
Inspectors also found the company mixed batches of apple juice to lower patulin levels, which isn’t allowed under federal law and still renders the finished product adulterated, according to the warning letter.
Batches containing more than 50 parts per billion of patulin were diverted by Hood River Juice Co. for products intended to be fermented for vinegar or cider, the FDA said. The agency recommended the company get “written assurances” from clients that fermentation would occur.
David Ryan, the company’s president, did not reply to requests for comment.