San Diego, CA—As an example of Commissioner Margaret Hamburg’s efforts to make “swift, aggressive and effective enforcement” of its regulations, Lifesoy, Inc., a manufacturer of ready-to-eat soy products was cited by the U.S. Food and Drug Administration (FDA) for preparing, packaging and holding articles of food in unsanitary conditions. FDA issued a decree that requires Lifesoy to stop manufacturing and distributing food products including its sweetened and unsweetened soymil, fried tofu, fresh tofu and soybean pudding. FDA entered a consent decree of permanent injunction against the company and its owner Long H. Lai. The decree prohibits the company from receiving, preparing, processing, distributing or packaging food products until it comes into compliance with the terms of the consent decree. The citation against Lifesoy also holds that the company did not store the foods under proper refrigeration conditions to prevent the growth of microorganisms. Products were prepared under such conditions that they might have been contaminated and become harmful to one’s health.

As part of the decree, Lifesoy must retain a qualified sanitation expert to help implement a proper sanitation program to ensure that Lifesoy follows proper sanitation practices and it complies with Good Manufacturing Practices. Before the company can re-open, FDA must approve of its sanitation program and have the agency re-inspect the facility.
Lifesoy was inspected by FDA in 2007, but failed to comply with food safety laws at that time, resulting in this current action.

Published in WholeFoods Magazine, Aug. 2010 (epub July 21, 2010)