FDA unconcerned about vomiting caused by fungus-based faux meat

The Food and Drug Administration has allowed a fake meat made from fungus onto the marketplace, even though the agency knows it makes some people seriously ill, according to the nonprofit Center for Science in the Public Interest (CSPI).

Quorn is the brand name for a line of foods made from “mycoprotein.” Quorn products take the form of faux chicken patties, nuggets, and cutlets, as well as imitation ground beef. It springs from a single-celled fungus grown in large fermentation vats by Marlow Foods, a division of the multinational pharmaceutical company AstraZeneca.

Today, CSPI asked the FDA to halt the marketing of Quorn products and to direct Marlow Foods to recall its product from grocers’ shelves. Also today, consumers who became ill after eating Quorn spoke out at a Washington, D.C., news conference.

“I trusted that the FDA would not allow unsafe or mislabeled foods on the market,” said 22-year-old student Laura Hubbard, who vomited five times and then passed out after eating a Quorn cutlet. “Now I feel like that trust has been broken.” Hubbard required emergency-room treatment for dehydration.

Hubbard is one of more than 30 American and European consumers who contacted CSPI with reports of adverse reactions after eating Quorn. Most of those consumers vomited several hours after eating the product. Some experienced diarrhea, and one North Carolina man reported hives and difficulty breathing after eating Quorn. CSPI received those reports via a web site, www.QuornComplaints.com.

Earlier this year, CSPI filed complaints with the FDA and European food authorities about the safety and labeling of Quorn products. Quorn’s packaging describes mycoprotein as “mushroom in origin” and a “small, unassuming member of the mushroom family,” when according to fungus experts, Quorn’s vat-grown fungus is only distantly related to mushrooms.

In March, Professor David M. Geiser of the Fusarium Research Center at Pennsylvania State University told the FDA that calling Fusarium venenatum, the fungus that is the basis of Quorn foods, a mushroom is like “calling a rat a chicken because both are animals.” Quorn’s fungus is actually a mold, according to Geiser.

Since then, the American Mushroom Institute, the British Mushroom Bureau, and the Gardenburger corporation, which uses real mushrooms in some of its products, have also criticized Marlow Foods’ linking of Quorn to mushrooms. Government officials in the United Kingdom have since directed Marlow Foods to suspend its use of the term “mushroom protein” in Quorn advertisements there.

CSPI’s concerns about Quorn’s labeling and advertising, though, have taken a back seat to concerns about the product’s safety, especially after documents obtained by CSPI under the Freedom of Information Act indicate that more people have adverse reactions to Quorn than previously claimed. One study, filed by Marlow Foods as part of its notification to the FDA asserting that mycoprotein is generally regarded as safe (GRAS), found that as many as 10 percent of people reported vomiting, nausea, or stomach aches after eating Quorn up to eight different times, compared with 5 percent in a control group. Marlow Foods claims publicly that one in 130,000 consumers has an adverse reaction.

“The data argue compellingly that the mycoprotein derived from Fusarium venenatum is almost certainly gastrotoxic,” said Dr. David A. Morowitz, a Clinical Professor of Medicine (gastroenterology) at Georgetown University. “The risk of its toxicity does not justify its continued use here in the United States, absent additional safety studies.”

“The FDA’s stance with regard to Quorn has been ‘get sick first, ask questions later,’” said CSPI executive director Michael F. Jacobson. “This product was cavalierly waved through by the FDA with an alarming lack of curiosity, considering that this particular mold is a new entrant into the human food supply, and considering that the FDA knew that a study showed that this product would make some people violently sick.”

“On theoretical grounds alone, the use of this mold in food is highly dubious,” said Dr. John Santilli, a Bridgeport, Connecticut allergist. “Intentionally increasing consumer exposure to mold through the food supply will only increase the risk of discomfort and adverse reactions in mold-sensitive consumers.”

“Naturally, I just assumed that this product would be safe to eat,” said Victor Stanwick, a computer programmer from Staten Island, who twice fell ill after eating Quorn imitation chicken patties. “I hope the government takes action to protect people from this product. Until then, I’d encourage people to avoid Quorn altogether.”

The FDA first accepted Marlow Foods’ GRAS designation of Quorn last January. A petition to have mycoprotein approved as a food additive is pending at the agency, as is a separate complaint from CSPI urging FDA to forbid deceptive terms like “mushroom in origin” on Quorn labels.

“Why ‘natural-food’ stores, in particular, would sully their reputations by selling these vomitburgers is beyond me,” Jacobson said.

Dr. W. Ted Kniker, an allergist, urged caution about Quorn. “I am very troubled by Quorn’s side effects,” Kniker said. “Unnecessary and inadequately tested new ingredients that may cause widespread problems have no place in the food supply.” Dr. Kniker, formerly a professor of pediatrics and internal medicine at the University of Texas Health Science Center at San Antonio, serves on the adverse reactions to foods committees of the American Academy of Allergy, Asthma and Immunology.