A 19-year-old Michigan juice company with day care centers carved out as a market niche is failing to pasteurize its products, according to the U.S. Food and Drug Administration (FDA).

In a Sept. 8 warning letter to Penguin Juice Company Inc., FDA told the company its “concentrated ‘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.”

FDA said that during an inspection of Penguin’s juice processing facility in Westland, MI, its “investigator observed that you are not implementing a pasteurization step listed in your HACCP plan for ‘100% Juice Concentrates’ and ‘100% Juice Blend Concentrates’ to control the food safety hazard of pathogens,” FDA wrote.

“Specifically, it was observed that no pasteurization was performed for ‘100% Juice Blend Concentrates,’ Clear Raspberry flavor.”

Juice made without the benefit of pasteurization has been increasingly rare since an E. coli outbreak 14 years ago was linked to unpasteurized Odwalla apple juice.  One child died and 65 people, mostly children, were infected.  


In addition to paying out millions to compensate the victims, Odwalla also pleaded guilty to 16 federal criminal charges and agreed to pay a $1.5 million fine.

During the inspection, Penguin told the FDA investigator that its 100% Juice Blend Concentrates are heated, but this does not meet the goal of Pasteurization 5 Log reduction as a critical control point to control the food safety hazard of pathogens.

A “5-log reduction” means lowering the number of microorganisms by 100,000-fold, that is, if a surface has 100,000 pathogenic microbes on it, a 5-log reduction would reduce the number of microorganisms to one.

FDA said the juice maker is “not performing a 5-log pathogen reduction measure” for its “100% Juice concentrates” and “100% Juice Blend Concentrates.”  

In addition to a long list of corrective actions that Penguin must take to bring its HACCP plan into compliance, FDA said the company’s Natural Apple Juice Blend Concentrate, White Blend Juice Concentrate, and Passion Fruit Juice Blend concentrate are misbranded with label language saying they are “From Pasteurized Quality Product.”

“This may lead a consumer to believe that your product has been pasteurized or otherwise treated to achieve a 5-log pathogen reduction, ” FDA said.  “However, based on our investigation, your product is neither pasteurized nor treated to achieve a 5-log pathogen reduction.”

Penguin has until the end of the month to inform FDA of the corrective actions it is taking to comply with all the laws and regulations cited in the warning letter.