Harmless Harvest (not so harmless) to temporarily suspend bottling operations following FDA warning letter

Posted on December 28, 2015 by


by Doug Powell

With a bullshit name like Harmless Harvest, you gotta except some extra harmless scrutiny.

 Coconut water company Harmless Harvestd will temporarily halt bottling products due to concerns by the U.S. Food and Drug Administration (FDA) over the safety of processing methods used in the company’s Thailand facility.

HarmlessCoconutWaterThe company, which for several years marketed its product as “raw”, has long leaned on high pressure processing (HPP) and proprietary processes shared with the FDA to ensure the safety of its products. But a recent warning letter from the FDA to the San Francisco-based company indicates that no longer may be enough.

In a letter dated Nov. 13, William A. Correll Jr., director of the Center for Food Safety and Applied Nutrition’s office of compliance, informed Harmless Harvest of several “serious violations” of the juice Hazard Analysis and Critical Control Point (HAACP) regulations, relating to its ability to eliminate potentially hazardous spores through microfiltration at its Thailand processing facility.

“Our review of the information and documentation provided by your firm reveals that the coconut juice products manufactured by your firm and offered for entry into the United States are processed in a manner that does not comply with the juice HACCP regulation, 21 CFR Part 120,” wrote Correll.

Among the violations listed in the letter is the claim that Harmless Harvest’s HAACP plan does not adequately demonstrate a 5-log reduction of spores of Cholostridium botulinum, which can cause botulism.

Harmless Harvest’s recently appointed CEO, Gianella Alvarez, addressed the issue in a statement published on Harmless Harvest’s website, saying the company is currently working alongside “FDA regulators, other oversight agencies and expert consultants” to make “process enhancements” that will ensure compliance with the FDA’s regulatory regulations.”

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Posted in: Family safety