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. The process of inserting genes into an organism, Regal adds, can cause mutations to existing genes of the organism, creating toxins. According to an FDA official who spoke on the record but asked not to be named, 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.
However, in his 1992 memo, Pribyl of the FDA criticized this voluntary testing. 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 . In response, the FDA recently concluded a series of three public meetings to inform the public about its policy for ensuring the safety of bioengineered foods and to ask for input about whether that policy should be changed. 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.