An Australian company has been fined after a case of botulism was linked to mislabeling of its bottles.
Inside Out Nutritious Goods pleaded guilty at the earliest opportunity to 10 offenses brought by its regulator, the NSW Food Authority.
Judge Anthony Payne in the Supreme Court of New South Wales (NSW) ordered the defendant to pay US$120,000 ($78,000) and US$75,000 ($48,000) to cover prosecutor's costs.
The crimes occurred between October 2022 and January 2023. Incorrect storage instructions were printed on the labels of almond milk and oat milk products sold by Woolworths' Inside Out.
One man became seriously ill after consuming a dairy alternative and was hospitalized for almost six months.
Marking error
According to the decision, the process of heat pasteurization of the products was insufficient to inactivate Clostridium botulinum, the bacteria that can cause botulism poisoning. The offenses involved the mislabeling of 10 batches of almond and oat milk products totaling 46,494 bottles.
The following storage instructions should have been included on the drink label: “Product should be kept refrigerated (below 5 degrees Celsius) at all times.” Instead, they were incorrectly labeled: “Once opened, refrigerate and consume within 5 days.”
The labeling error was the result of human error. The incorrect label was prepared for another ultra-high temperature (UHT) product, but was accidentally copied onto the new product's packaging. The error was not detected during the Inside Out proofreading stage.
In January 2023, internal company emails stated that mislabeling had been discovered and a risk assessment had been carried out. A fact sheet on food recalls was produced in February. Of the 198,550 mislabeled bottles sold, 177,881 could not be traced. As part of sentencing, the judge took into account the delay in the product recall.
Consumer disease
Inside Out's corrective actions included personnel and process changes, as well as changes to the quality manual and production flow chart for critical hazard analysis control points.
In November 2022, Caryn McGrigor purchased unsweetened almond milk from Woolworths online. McGrigor kept the bottles in the kitchen cabinet. Her partner, Mr Mace, later drank almond milk and became seriously ill. In January 2023, one of these bottles tested positive for Clostridium botulinum.
Mace was hospitalized for 188 days from January to July 2023. The 61-year-old spent 147 days in the intensive care unit and was officially diagnosed with botulism in February 2023.
The judge was satisfied beyond a reasonable doubt that Mace became ill after consuming the Inside Out product. However, it was not proven that Mace or his partner acted in accordance with the label directions before storing the product in the cabinet. The judge was not satisfied that incorrect storage instructions played any role in causing the disease.
“The most important findings are that this offense was, in essence, a closely related series of unintentional errors resulting in offending conduct that had a low risk of causing harm but had the potential for catastrophic consequences if that harm occurred,” the ruling said.
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