FDA to Set Thresholds for Food Allergen Levels

The Food and Drug Administration has announced plans to set regulatory thresholds for major food allergens.

The move follows the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004. The Act was enacted to make it easier for consumers to identify ingredients in foods that might cause an allergic reaction. The major food allergens, as defined by FALCPA, include milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans, as well as proteins derived from such foods.

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Noting the problem of cross-contamination – the inadvertent introduction of an allergen into a product that does not intentionally contain it – the FDA plans to set regulatory thresholds for food allergens. According to the FDA, "The establishment of regulatory thresholds or action levels for major food allergens would help us determine whether, or what type of, enforcement action is appropriate when specific problems are identified... Regulatory thresholds also would help industry to conduct allergen hazard analyses and develop standards for evaluating the effectiveness of allergen preventive controls."

FDA Invites Public to Comment

In setting the threshold, the FDA is examining a number of questions. In particular, they are inviting public comment on questions such as "How should the FDA define “an allergic response that poses risk to human health?"" and "What data or other information exist on current levels of exposure associated with the consumption of undeclared major food allergens in packaged foods?"

David Acheson, former FDA associate commissioner for foods, explained "FDA is seeking input prior to setting a regulation that would have significant impact on anyone who uses any of the major food allergens in any of their products — or if there is any possibility that an allergen was introduced at any point in your chain of supply.” He continued, "The Food Safety Modernization Act does recognize allergens as a hazard and requires preventive controls, but defining and setting a hard-and-fast threshold certainly needs to take a great deal more information into consideration. I would highly encourage you to respond during the comment period, which ends Feb. 13, 2013, and provide any comment, and especially any data, that would have an impact on the decision."

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