FDA Asked To Evaluate Quorn's Safety 34566

FDA Asked To Evaluate Quorn's Safety

WASHINGTON--On Aug. 12, the Center for Science in the PublicInterest (CSPI) asked the Food and Drug Administration (FDA) to request thatMarlow, England-based Marlow Foods stop the sale of and recall QuornT productsin the United States. The public interest group reported at its meeting with FDAthat it was concerned not only with Marlow Foods' marketing and labeling of theproduct, but also the safety of Quorn, a mycoprotein derived from Fusariumvenenatum.

CSPI reported to FDA--which granted GRAS (Generally Recognized As Safe)status to Quorn in January 2002--that many consumers have reported becoming illafter eating Quorn; in fact, a 22-year-old student testified before FDA that shevomited five times before passing out after eating a Quorn cutlet, and she waslater treated in the emergency room for dehydration. She is one of more than 30people who have contacted CSPI and reported adverse reactions after eating Quornproducts. The most comment complaint was diarrhea, although one man reportedhives and breathing difficulties.

Earlier this year, CSPI wrote its first complaint letter to FDA and statedQuorn product labels were misleading. One such label read, "`Mycoprotein'comes from a small, unassuming member of the mushroom family, which we fermentlike yogurt." CSPI rebutted this statement in its FDA letter. "Themycoprotein in this product has nothing to do with mushrooms.... The mycoproteinis produced as a continuous fermentation product and is considered a single-cellprotein," the public interest group wrote. "Though it is obvious whythe manufacturer does not wish to define mycoprotein as fungal in origin, itshould be required to do so and not deceive consumers about the nature of itsproduct." CSPI went on to write that Quorn is not fermented like yogurt,which uses bacteria, not the fungi used in the Quorn process.

This Feb. 28 FDA letter was followed up with another one dated April 24, aswell as with letters filed with the United Kingdom's Food Standards Agency andthe European Union. In an Aug. 12 report from the Association Press, an FDAspokesperson speaking on the condition of anonymity stated the agency wouldreview and evaluate all available data on Quorn before proceeding with anyactions.

According to a Quorn spokesperson, Quorn products have been used in Europefor the past 17 years by 20 million consumers who have eaten approximately 1billion servings. "Quorn foods enjoy a 64-percent repeat sales rate, higherthan those of Morningstar Farms, Boca Burger and Gardenburger in the UnitedStates," the company stated.

David Wilson, vice president and general manager of the U.S.-based officeQuorn Foods Inc. in Riverside, Conn., reported the number of adverse eventsreported by CSPI are ridiculously small. "The sensitivity rates for Quornare much lower, actually, than for other protein sources such as soy protein,milk or shellfish," he said, adding that FDA has not specifically asked thecompany for a response to CSPI's allegations. "We're in constant contactwith FDA, especially since they're currently working on our food additivepetition. We share information with them on a weekly basis."

Quorn products--which include non-meat chicken patties, nuggets andcutlets--may soon be some other company's battle. In June, Marlow Foods' parentcompany, London-based AstraZeneca, put Marlow Foods' and the Quorn brand up forsale in AstraZeneca's attempt to focus on its pharmaceutical business. Accordingto the British paper Sunday Business (www.sundaybusiness.co.uk),analysts believe the business could go for 100 million pounds (US$154 million).