At the request of Food and Drug Administration (FDA), the US Department of Justice has filed a complaint for permanent injunction against the New York-based company to stop it producing and distributing its juice and other products.
Mystical One’s owners are being charged under the Federal Food, Drug, and Cosmetic Act for failing to have a Hazard Analysis and Critical Control Point (HACCP) plan for certain juice products, such as Fresh Carrot Juice.
Among the violations observed by FDA investigators were failures to adequately heat low-acid vegetable juices to destroy or prevent growth of dangerous microorganisms, properly clean food-contact surfaces, and maintain and monitor sanitation conditions at the New York manufacturing facility.
Major enforcement action
Marc Ullman, partner at US food and drug law firm Ullman, Shapiro & Ullman, told BeverageDaily.com that this is a major enforcement action in which the FDA is basically seeking to put the company out of business.
“It should send an important message that FDA takes food safety issues very seriously and that companies that are either unwilling or unable to implement even the most basic food safety programs (in this case a legally mandated HACCP plan) should not be selling anything that people ingest,” he added.
According to Ullman, it is unusual but “certainly not unheard of” for FDA to take this kind of action where a company has indicated it has no intention of complying.
Failure to respond
The FDA’s most recent inspection at the Mystical One facility in August 2010 found the same or similar violations observed during previous inspections.
Ullman said the agency issued a warning letter to the company in October 2009 noticing serious violations of the FD&C Act that could have warranted an injunction action in the first instance.
“The company promised to undertake corrective action and then apparently figured FDA would never follow up,” said Ullman.
According to Ullman, it would have been surprising if the FDA did not seek an injunction under these circumstances.
“Companies that conduct themselves in this manner should expect to be brought into court by FDA every time they are caught behaving this way,” he added.
Bacteria risk
The agency said it requires all juice processors to prepare and implement HACCP plans that identify and control food hazards associated with their juices, and it requires all food manufacturers to follow Good Manufacturing Practice (cGMP).
Although the FDA is not aware of illnesses associated with Mystical One’s juice products, the agency is concerned that failure to identify and control food hazards could lead to the formation of Clostridium botulinum bacteria that can germinate in carrot juice.
“The neurotoxin formed by these bacteria, when ingested in even very small amounts, could cause paralysis, difficulty breathing and death from asphyxiation,” said the FDA.
In 2006, six cases of botulism in the US and Canada were linked to refrigerated carrot juice, according to the agency.
“Beverage products produced under conditions that do not comply with HACCP or GMP requirements are considered adulterated under the Act,” the FDA said.
Mystical One purchases ingredients such as carrots that originate outside of New York and sells products to food service establishments primarily in New York, Connecticut, and Pennsylvania.