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Consider allergy or mast-cell evaluation when Hives, swelling or wheezing are prominent Symptoms occur without a clear food-histamine relationship Multiple environmental or medication triggers are present Episodes are systemic or severe Consider broader functional evaluation when Chronic diarrhea or malabsorption is present Food restriction keeps expanding Symptoms began after infection or major gastrointestinal disruption Diet and DAO provide only partial benefit A Practical Step-by-Step Plan Identify the dominant pattern Determine whether symptoms are mainly meal-related, allergy-related, mast-cell-like or associated with a persistent mood and behavioral pattern

FDA therefore says it lacks enough information to know whether such products would harm humans

Store lyophilized vials at 28C