Delores H. Campbell and Winston A. Fearon and their company, Juices Incorporated (also known as Juices International and Juices Enterprises), were 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 and beet juice products. The FDA requires all juice processors to have and implement HACCP plans that identify and control food hazards associated with their juices.
Among the violations observed by FDA investigators were failures to:
• adequately heat and refrigerate low-acid vegetable juices to destroy or prevent growth of dangerous microorganisms
• properly clean food-contact surfaces
• maintain plumbing in a manner that avoids a source of possible food and water contamination.
Failure to identify and control food hazards could lead to the formation of Clostridium botulinum (C. bot.) bacteria that can germinate in the carrot and beet juices made by the company. The neurotoxin formed by C. bot., when ingested in even very small amounts, could cause paralysis, difficulty breathing and potentially death from asphyxiation. In 2006, six cases of botulism in the United States and Canada were linked to refrigerated carrot juice. However, the FDA is not aware of illnesses associated with Juices Incorporated’s juice products.
The complaint also charges Juices Incorporated, Campbell and Fearon with failing to conform to current good manufacturing practice (GMP) requirements for making, packing, or holding human food. Juice products that are produced under conditions that do not comply with HACCP or GMP requirements are considered adulterated under the Act.
The FDA’s most recent inspection of the Juices facility in March 2010 found the same or similar violations observed during previous inspections of the company. The agency issued warning letters to the company in April 2008 and October 2009, and the company promised to bring its operations into compliance but did not make the necessary changes.
“Today’s action shows that FDA will seek enforcement action to make sure that those companies that must have preventative controls in place to ensure the safety of their products adhere to all applicable requirements,” said Associate Commissioner for Regulatory Affairs Dara A. Corrigan.
“Consumers must have a comfort level that the products they buy in their markets are safe to eat and to drink,” said Loretta E. Lynch, the United States Attorney for the Eastern District of New York. “We will continue to act with the FDA to ensure that companies that produce food and juice under dangerous conditions take corrective action.”