FDA Sends Warning Letter to Pressed Juicery

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The U.S. Food and Drug Administration (FDA) has sent a warning letter to Pressed Juicery following an inspection of the cold-pressed juice company’s manufacturing facility in Fresno, Calif. and a review of its Hazard Analysis and Critical Control Point (HACCP) plan.

In the letter dated March 23, 2016, FDA district director Kathleen M. Lewis wrote that Pressed Juicery failed to meet requirements of section 21 CFR 120 of the Federal Food, Drug and Cosmetic Act and as such, its juice products “are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.”

Pressed Juicery, which operates its juicing facility in California’s Central Valley, sells its products at more than 30 brick and mortar locations across the West Coast. In 2015, the company made its East Coast debut in New York City.

The primary violation listed in the FDA’s letter indicates that Pressed Juicery’s HACCP plan failed to demonstrate “control measures that will consistently produce, at a minimum a 5-log reduction of the most pertinent microoganisms of public health significance that is likely to occur in the juice, for as long as the shelf life of the product when stored under normal and moderate abuse conditions.”

While Pressed Juicery does not disclose its processing methods, citing proprietary methods, the named violation cites the company’s use of high hydrostatic pressure (HHP), a term the FDA uses interchangeably with high pressure processing. Over the past year, the FDA has taken the position that HPP alone is not an effective means of controlling the potential growth of C. botulinium spores in low-acid juices. In April, 2015, Columbia Gorge received a similar warning letter from the FDA. In December coconut water company Harmless Harvest was faced with a similar issue, eventually electing to end its use of HPP in favor of a new proprietary microfiltration process.

A second violation listed alleges the company has not accounted for all potential food hazards in its HACCP plan, namely patulin, a mycotoxin that can occur in apple juice from rotting apples.

Reached via e-mail, a spokesperson from Pressed Juicery provided BevNET with the following statement:

“Pressed Juicery is committed to providing safe products to our customers. We are confident in the safety of our products and take great pride in our track record. To date, we are not aware of a single verified incident relating to the safety of our products in the company’s history. We welcome the FDA’s input on further ensuring the safety of our products and are committed to addressing their concerns.”

The FDA has given Pressed Juicery has 15 days to respond to the letter and outline the actions it will take to correct the violations.