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Food Allergies - Rare But Risky

Food Allergies And Biotechnology

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People with food allergies have expressed the concern that new varieties of food, developed through the new techniques of biotechnology (such as gene splicing), may introduce allergens not found in the food before it was altered.

FDA addressed this concern in its 1992 biotechnology policy statement and said it will regulate whole foods developed through biotechnology by applying the same rigorous safety standards as for all other foods. The agency is taking steps to ensure that foods developed though biotechnology do not pose any new risks for consumers.

Under the new policy guidelines, a protein copied by genetic engineering from a food commonly known to cause an allergic reaction is presumed to be allergenic unless clearly proven otherwise. Any food product of biotechnology that contains such proteins must list the allergen on the label. Labeling would not be required if the manufacturer could demonstrate that the allergen was not transferred. For example, if a food company were to breed potatoes containing a genetically engineered soy protein (to which some people might be allergic), the labeling on the potatoes would have to disclose the presence of the soy protein. But labeling would not be required if scientific data clearly showed that the protein had been changed and no longer contained the soy allergen.

To ensure that FDA has state-to-the-art information for its food biotechnology policy, the agency will sponsor a scientific conference in the spring of 1994 to discuss what makes a substance a food allergen.

Last modified: December 2004
U. S. Food and Drug Administration
FDA Consumer
May 1994