Since the 1970s when Americans went through a few life-threatening botulism outbreaks because of low-acid foods improperly packaged in hermetically sealed containers, there have been rules in place to prevent that from happening.
Now the U.S. Food and Drug Administration (FDA) finds itself having to explain those rules to companies that export to the U.S.
Dong-A Otsukas Co. Ltd, a food and beverage manufacturer in Seoul, South Korea is one such company. FDA last Aug. 19-20 inspected Dong-A’s acidified food facility known as the Chilseo Factory.
Formed in 1979, Dong A makes an acidified beverage product call “Pocari Sweat.” The FDA inspection found there are “serious deviations between how ‘Pocari Sweat’ is made and U.S. acidified food regulations.”
In a Dec. 2nd warning letter to Dong A, FDA reminded the company that it is responsible for compliance with low-acid food regulation.
FDA said Dong A’s beverage product is adulterated in that it has been “prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.”
The U.S acidified food regulations include three major areas: emergency permit controls thermally processed low-acid foods, and those covering acidified foods. Together they cover equipment, controls, manufacturing, processing and packing to ensure a safe product.
FDA said Dong A did not properly register the acidified product it was making at the Chilseo factory. It did provide a copy of a filed scheduled process for an acidified non-carbonated beverage it makes at another factory for export to the U.S.
FDA also said the Korean company did not have a trained supervisor overseeing personnel involved in acidification, pH control, heat treatment, and other critical factors of its operation.
The Seoul-based company has 30 business days to respond to FDA. The agency said unless these issues are resolved, it may take further action including blocking its exports to the U.S.
Pocari Sweat, according to Wikipedia, is a non-carbonated, grapefruit-flavor sports drink that originated in Japan in 1980. The name “Pocari” has no meaning — it reportedly was coined for its light, bright sound — and while “Sweat” may seem a strange brand name to English speakers, it apparently was chosen by the manufacturers because the beverage is supposed to replenish nutrients and electrolytes lost through perspiration.