FDA Seeks Permanent Injunction against Mystical One LLC, Jamaica, NY

• Date: January 19, 2011
• Source: Admin

At the request of the US Food & Drug Administration (FDA), the US Department of Justice filed a com-plaint on Jan 13, 2011 against Mystical One LLC, Jamaica, NY, a beverage company.  The complaint sought a permanent injunction to prevent the company from processing and distributing juice and other products.  

According to the department, Hank J. Hagen and Milton S. Reid and their company violated the Federal Food, Drug, and Cosmetic Act by not putting in place a Hazard Analysis and Critical Control Point (HACCP) plan for some juice products like carrot juice.  The company also failed to comply with current Good Manufacturing Practice (cGMP).

FDA requires juice processors to implement HACCP plans so they can identify and control food hazards associated with the juices.  Towards this end, all food manufacturers are required to comply with cGMP.  The FDA has not come across any instance of illness arising from the consumption of Mystical One’s juice products though.  Important amongst the violations cited by the FDA are the company’s failure to:
 

• adequately heat low-acid vegetable juices.  As a result, dangerous micro organisms are neither destroyed nor prevented from growing
• properly clean food-contact surfaces
• ensure perfect sanitation conditions at the facility to prevent sources of possible food and water contamination

Such failures could lead to the formation of clostridium botulinum bacteria that can germinate in the carrot juice manufactured. When consumed even in very small quantities, paralysis, difficulty in breathing and death from asphyxiation could result. In 2006, six cases of botulism were linked to refrigerated carrot juice in the US and Canada.

Regulations

cGMP provisions apply to making, packing, or holding human food.  When manufactured in contraven-tion of HACCP or GMP provisions, the law defines these beverage products as adulterated products.  

Sources:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm239965.htm