The product, Quorn, which is comprised of a fungus called mycoprotein, egg whites and other ingredients, comes in a variety of forms, including chicken-style nuggets and fillets. Although Quorn products were only introduced to the U.S. market in January, the manufacturer, Marlow Foods, has sold them in the United Kingdom since 1985.
Michael Jacobson, executive director of Center for Science in the Public Interest, said at a news briefing that his organization has heard from more than 90 people, including 16 Americans, who developed vomiting, diarrhea or other problems after eating Quorn products.
"Quorn products have been on the market for only a few months, but they clearly fail the test of safety," Jacobson said.
Marlow Foods' U.S. Director Dave Wilson called the allegations "quite ridiculous." The reports of people becoming ill "are unscientific and unsubstantiated," Wilson told United Press International. He noted that both the Food and Drug Administration and European health authorities have determined Quorn products to be safe.
Marlow Foods acknowledges that a small number of people may have a reaction to Quorn but this is far fewer than the number of people who are allergic to common foods such as fish, soy and milk.
Marlow claims that based on an analysis of the number of people in the United Kingdom who consume their products only one in 146,000 people experience a reaction to Quorn whereas they may be hundreds or thousands of times more likely to have a reaction to shellfish, soy or milk products.
CSPI denied this number, saying it is based on faulty data and does not account for the people who get ill but never report it or the people who have multiple servings of the product. "The true incidence" of people who get ill after consuming Quorn is much higher, ranging from 1 in 500 to 1 in 80, the group said.
Jacobson cited one study conducted by the company and submitted to the FDA that found that 10 percent of people who consumed Quorn's fungal ingredient experienced vomiting, stomachaches or nausea. This is about double the percentage of people who did not eat the fungus and who developed those symptoms.
Victor Stanwick, who got ill on two occasions after eating Quorn products, said he was "projectile vomiting for hours." Laura Hubbard, who also got violently ill from the meat substitute, said she had to be taken to the hospital and treated for dehydration after vomiting five times.
A spokeswoman for the Food and Drug Administration who requested anonymity said the agency has not received any complaints or reports of illness related to the products.
Marlow Foods did their own analysis in 2001 and determined mycoprotein to be safe. The FDA has reviewed this analysis and "based on our evaluation, we have no questions at this time regarding their conclusions," the agency spokeswoman told UPI.
She noted, however, "We have not seen these reports" of illness CSPI refers to, but "we are interested in seeing them."
CSPI submitted some of those reports to FDA Monday along with a request that the agency take the Quorn products off the market.
Jacobson conceded that the causes of the illnesses are unknown. It could be due to a toxin produced by the fungus -- which Marlow Foods is aware of and thus grows the fungus under conditions that prevent the formation of toxins -- or simply due to allergic reactions to the ingredient, he said.
Jacobson says the people who they have heard from "are undoubtedly the tip of the iceberg" because most people who have experienced illness due to the Quorn products are unlikely to report it. In addition, Marlow Foods plans to increase sales of the product and this will lead to more cases of illness, he warned.