Tag Archives: anaphylaxis

Allergens

FDA Issues Draft Guidance Emphasizing Increased Importance on Food Allergens

By Food Safety Tech Staff
No Comments
Allergens

Today the FDA issued a draft guidance that shines a spotlight on the importance of assessing food allergens that are not one of the nine major food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, sesame and soybeans). “The nine major food allergens don’t currently represent all foods nationwide that people are allergic to or that cause food hypersensitivities,” said CFSAN Director Susan Mayne, Ph.D., in an agency release. “This draft guidance is part of the FDA’s efforts to evaluate emerging evidence about other non-listed food allergens that can cause serious reactions in a consistent and transparent manner, which can inform potential future actions to better help protect the health of consumers.”

The draft, “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act”, targets immunoglobulin E antibody (IgE)-mediated food allergies, which can cause severe and life-threatening reactions such as anaphylaxis. The document reviews the evidence that establishes a food as a cause of IgE-mediated food allergy and scientific factors, such as prevalence, severity and allergenic potency, that the FDA would consider in evaluations. It also reviews the agency’s recommendations for identifying and evidence to determine the public health importance of a non-listed food allergen.

Comments on the draft guidance can be submitted by August 17, 2022.

FDA

Drug to Mitigate Peanut Allergies in Kids Gets FDA OK

By Food Safety Tech Staff
No Comments
FDA

On Friday FDA announced the approval of a drug to mitigate allergic reactions to accidental peanut exposure in children. Manufactured by Aimmune Therapeutics, Palforzia is intended for use in children who are four years through 17 years old. FDA points out that there is no cure for a peanut allergy and so peanuts must continue to be avoided.

Palforzia is a powder made from peanuts and administered in capsule and sachet form via three phases, the first of which occurs under the supervision of a healthcare professional. This first phase, called “initial dose escalation”, involves administration of a single capsule. The second phase, “up-dosing”, is a phase of 11 increasing dose levels over a period of several months (the first dose of this phase is also administered under watch by a healthcare professional, while the remaining doses can be taken daily at home). Following completion of the second phase, a patient begins the “maintenance” treatment, which is delivered via a sachet (the powder can be mixed with foods such as applesauce and yogurt).

“Peanut allergy affects approximately 1 million children in the U.S. and only 1 out of 5 of these children will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research in an agency press release.

Palforzia is available through healthcare providers, healthcare settings and pharmacies that receive special certification and are educated on the risk of anaphylaxis in using the drug. Patients interested in receiving the drug must be part of FDA’s risk evaluation and mitigation strategy program.