REPORT FROM THE DEPARTMENT OF HEALTH – The Hawaii State Department of Health’s (DOH) Food and Drug Branch has issued a Notice of Violation and Order against Koyo USA Corp. for adulterating its bottled water product and for manufacture, sale and distribution of bottled water for human consumption from an unapproved source. A penalty of $5,044,193 has been issued for violations of Hawai‘i Revised Statutes sections 328-6 and 328D-2 that occurred from July 7, 2006 to May 19, 2011. Koyo’s product is branded as Mahalo Hawai‘i Deep Sea and has been marketed to consumers in Japan, Hawai‘i and elsewhere.
Koyo USA Corp. was permitted to filter ocean water at its Kona facility and produce a bottled drinking water product. Koyo USA Corp. is required to adhere to a specific process in making bottled water from the ocean source.
The DOH Food and Drug Branch began an investigation of Koyo USA Corp. on May 18, 2011 in response to an anonymous complaint. The investigation confirmed Koyo USA Corp. had not adhered to the process for filtering ocean water approved by DOH in 2006. Instead, the company purposefully diverted concentrated ocean water that had been rejected by its reverse osmosis system and, through bypass piping, blended it into their final bottled water product. The department issued an Order to Cease and Desist on May 19, 2011.
No recall or embargo of the Koyo bottled water products is being initiated by DOH. Test results from independent laboratories and the state laboratory have confirmed that consumption of the affected bottled water product does not pose an immediate and/or substantial risk to human health. Koyo performed a disinfection process prior to their water product being sold.
“Made in Hawai‘i means the highest quality” said Gary Gill, Deputy Director for Environmental Health, “People expect Hawai‘i products to be completely safe and manufactured to the highest standards. Any company that cuts corners and violates this trust harms the reputation of our islands and the good name of every product made in Hawai‘i.”
The DOH Food and Drug Branch in cooperation with the Safe Drinking Water Branch conducted an inspection of three other state-permitted deep sea water bottling companies in Kona and found them in compliance with state regulations. Destiny, Hawai‘i Deep Marine and Kona Deep brand bottled waters have not violated their permits and are not part of this notice and penalty.
Since the Department’s discovery of the violation, Koyo USA Corp. has been cooperative in correcting the unpermitted drinking water filtration process. The operation at the Koyo plant is being monitored by the Department. The company has 20 days in which it may contest the Notice of Violation and Order and request a hearing.
The DOH Food and Drug Branch regulates food, drugs, cosmetics, medical devices and related consumer products within the state. It protects public health by ensuring products are safe, effective and properly labeled. The program conducts inspection of establishments where these products are manufactured, distributed, or sold. It also investigates complaints, and collects samples to determine compliance with product standards.