October 28, 2016

Harmless Harvest Thailand Sent FDA Warning Letter

The FDA sent a warning letter to Harmless Harvest Thailand last month, telling them that their 100% Raw Coconut Water products are considered hazardous, since they are processed in a manner that does not comply with the juice Hazard Analysis and Critical Control Point (HACCP) Systems regulation.  The juice products are considered adulterated within the meaning of the Federal Food, Drug, and Cosmetics Act.

FDAlogoThe firm provided documentation and information about the processing methods used to make this product. Those methods did not meet the FDA’s regulation. The micro filtration process, risk assessment for that process, the HACCP plan and manual, and documentation about High Pressure Processing (HPP) were not adequate.

The company must included control measures that will consistency produce a 5-log reduction in microorganisms for a period at least as long as the shelf life of the product when sorted under normal and moderate abuse conditions. The microorganism that is most likely to be a problem for this product is Clostridium botulinum.

Clostridium botulinum spores can germinate and grow in low acid juices such as coconut juice, producing toxins that can cause serious illness and death. FDA requires that this hazard is controlled in juice products.

The FDA is concerned with the safety of the water that comes into contact with the product’s packaging. In addition, contaminants in the bottles and caps can serve as a source of biological contamination.

The firm told the FDA that the coconut juice products are supposed to be “further processed” in the U.S. via HPP, but the HACCP plan for the HPP processor doesn’t identify the reasonably likely hazard of botulism toxin.  Several instances of botulism poisoning from refrigerated carrot juice indicate the need for control of this microorganism.

The company is temporarily ending their bottling process over these safety concerns. The company has marketed its product as “raw” in the past, and has depending on high pressure processing and other proprietary processes to make their products safe. Harmless Harvest is working with the FDA regulators to enhance their production process.

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