The FDA outlines a new framework for evaluating potential food allergens


Signage is seen outside the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, the United States, August 29, 2020. REUTERS/Andrew Kelly

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(Reuters) – The US Food and Drug Administration on Monday issued new draft guidance on how the agency plans to assess the public health importance of food allergens, going beyond those currently recognized as the main threat.

While many foods can cause allergies, the FDA currently recognizes eight — milk, egg, fish, shellfish, tree nuts, peanuts, wheat, and soybeans — as major allergens. A ninth, Sesame, is set to be added to the list next year. According to federal regulations, packaged foods containing these ingredients must be labeled.

These nine food allergens involve a type of antibody known as immunoglobulin E, which can trigger a life-threatening reaction. The FDA said Monday’s draft guidelines are part of the agency’s effort to evaluate new evidence about other unlisted food allergens that can cause serious reactions.

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It is subject to a 120-day public notice and comment period before becoming final.

The guidance sets out what evidence the Agency will consider when evaluating such allergens, including human exposure data. It establishes a grading system for allergic reactions, ranging from mild to moderate to severe, which is used together with the prevalence of an allergy in the population to assess the threat it poses.

The guidance does not detail what specific steps the agency might take after assessing the threat of a potential allergen.

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Brendan Pierson

Brendan Pierson covers product liability litigation and all aspects of healthcare law. He can be reached at [email protected]


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