According to Druker, who studied government reports of the incident, the supplement was genetically engineered by Showa Denko K.K., a manufacturer based in Japan. Shortly after the supplement was put on the market, many people who took it became ill with eosinophilia myalgia syndrome, a potentially fatal and debilitating disease. He said the process of insert-ing genes into an organism can cause mutations to existing genes of the organism, creating toxins. The agency gives guidance to manufacturers about safety testing, using a flowchart. When they find a problem, they stop production.
Companies have an interest in producing a safe product.
THE FDA faces increasing pressure from consumer groups and, more recently, congressional leaders to change its biotech food policy. Last June, a group called Mothers for Natural Law delivered petitions with 500,000 signatures to the FDA demanding safety testing and labeling. Consumers Union, the oldest and largest association of American consumers with 4.7 million member households, called for the same in its September issue of Consumer Reports . We want to get information from the American public and want to know if what we're doing is good enough to make people feel comfortable. We will consider everything we hear.