Company’s failure to correct violations prompts court action
At the request of the U.S. Food and Drug Administration, the U.S. Department of Justice today filed a complaint for permanent injunction against a Jamaica, N.Y.-based beverage company to prevent it from processing and distributing juice and other products.
Hank J. Hagen and Milton S. Reid and their company, Mystical One LLC (also known as Mystical One Juice LLC), are charged with violating the Federal Food, Drug, and Cosmetic Act by failing to have a Hazard Analysis and Critical Control Point (HACCP) plan for certain juice products, such as the company’s carrot juice products, and by failing to comply with current Good Manufacturing Practice (cGMP).
The FDA 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 cGMP. The FDA is not aware of illnesses associated with Mystical One’s juice products.
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 manufacturing facility to prevent sources of possible food and water contamination.
Failure to identify and control food hazards could lead to the formation of Clostridium botulinum bacteria that can germinate in the carrot juice made by the company. The neurotoxin formed by these bacteria, when ingested in even very small amounts, could cause paralysis, difficulty breathing and death from asphyxiation. In 2006, six cases of botulism in the United States and Canada were linked to refrigerated carrot juice.
The complaint also charges Mystical One, Hagen and Reid with failing to conform to cGMP requirements for making, packing, or holding human food. Beverage products produced under conditions that do not comply with HACCP or GMP requirements are considered adulterated under the Act.
Violations cited by the FDA involved the following brands:
• Fresh Carrot Juice,
• Magnum Food Drink,
• Pineapple Ginger Drink,
• Sorrel & Ginger,
• Sea Moss, and
• Peanut Punch.
The company 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.
The FDA’s most recent inspection at the Mystical One facility in August 2010 found the same or similar violations observed during previous inspections of the company. The agency issued a warning letter to the company in October 2009 and the company agreed to bring its operations into compliance. However, Mystical One did not make the necessary changes.
"This action shows that FDA will take strong enforcement action against companies that fail to put the required preventive controls in place to protect their customers from foodborne illness," said Associate Commissioner for Regulatory Affairs Dara A. Corrigan. "Mystical One failed to adhere to food safety guidelines and we have asked the court to stop their operation."
The injunction was filed by the Office of Loretta E. Lynch, United States Attorney for the Eastern District of New York, together with the Department of Justice’s Office of Consumer Litigation.
For more information:
2009 Warning Letter to Mystical One LLC
FoodSafety.gov – Botulism
At the request of the U.S. Food and Drug Administration, the U.S. Department of Justice today filed a complaint for permanent injunction against a Jamaica, N.Y.-based beverage company to prevent it from processing and distributing juice and other products.
Hank J. Hagen and Milton S. Reid and their company, Mystical One LLC (also known as Mystical One Juice LLC), are charged with violating the Federal Food, Drug, and Cosmetic Act by failing to have a Hazard Analysis and Critical Control Point (HACCP) plan for certain juice products, such as the company’s carrot juice products, and by failing to comply with current Good Manufacturing Practice (cGMP).
The FDA 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 cGMP. The FDA is not aware of illnesses associated with Mystical One’s juice products.
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 manufacturing facility to prevent sources of possible food and water contamination.
Failure to identify and control food hazards could lead to the formation of Clostridium botulinum bacteria that can germinate in the carrot juice made by the company. The neurotoxin formed by these bacteria, when ingested in even very small amounts, could cause paralysis, difficulty breathing and death from asphyxiation. In 2006, six cases of botulism in the United States and Canada were linked to refrigerated carrot juice.
The complaint also charges Mystical One, Hagen and Reid with failing to conform to cGMP requirements for making, packing, or holding human food. Beverage products produced under conditions that do not comply with HACCP or GMP requirements are considered adulterated under the Act.
Violations cited by the FDA involved the following brands:
• Fresh Carrot Juice,
• Magnum Food Drink,
• Pineapple Ginger Drink,
• Sorrel & Ginger,
• Sea Moss, and
• Peanut Punch.
The company 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.
The FDA’s most recent inspection at the Mystical One facility in August 2010 found the same or similar violations observed during previous inspections of the company. The agency issued a warning letter to the company in October 2009 and the company agreed to bring its operations into compliance. However, Mystical One did not make the necessary changes.
"This action shows that FDA will take strong enforcement action against companies that fail to put the required preventive controls in place to protect their customers from foodborne illness," said Associate Commissioner for Regulatory Affairs Dara A. Corrigan. "Mystical One failed to adhere to food safety guidelines and we have asked the court to stop their operation."
The injunction was filed by the Office of Loretta E. Lynch, United States Attorney for the Eastern District of New York, together with the Department of Justice’s Office of Consumer Litigation.
For more information:
2009 Warning Letter to Mystical One LLC
FoodSafety.gov – Botulism
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