FDA Asked To Evaluate Quorn's SafetyFDA Asked To Evaluate Quorn's Safety

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

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

Earlier this year, CSPI wrote its first complaint letter to FDA and stated Quorn product labels were misleading. One such label read, "`Mycoprotein' comes from a small, unassuming member of the mushroom family, which we ferment like yogurt." CSPI rebutted this statement in its FDA letter. "The mycoprotein in this product has nothing to do with mushrooms. . The mycoprotein is produced as a continuous fermentation product and is considered a single-cell protein," the public interest group wrote. "Though it is obvious why the manufacturer does not wish to define mycoprotein as fungal in origin, it should be required to do so and not deceive consumers about the nature of its product." 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, as well as with letters filed with the United Kingdom's Food Standards Agency and the European Union. In an Aug. 12 report from the Association Press, an FDA spokesperson speaking on the condition of anonymity stated the agency would review and evaluate all available data on Quorn before proceeding with any actions.

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

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

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