F.D.A. approves peanut allergy claim

by Jeff Gelski
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Baby eating cookie made with peanuts
Giving infants peanut-containing foods may reduce their risk of developing allergies.
 

WASHINGTON — The Food and Drug Administration on Sept. 7 for the first time recognized a qualified health claim to prevent a food allergy.

The claim states, “For most infants with severe eczema and/or egg allergy who are already eating solid foods, introducing foods containing ground peanuts between 4 and 10 months of age and continuing consumption may reduce the risk of developing peanut allergy by 5 years of age. F.D.A. has determined, however, that the evidence supporting this claim is limited to one study.

“If your infant has severe eczema and/or egg allergy, check with your infant’s health care provider before feeding foods containing ground peanuts.”

Food manufacturers may use the claim immediately. The new claim does not cover whole peanuts, which are a choking hazard for young children and should not be consumed, said Scott Gottlieb, M.D., commissioner of the F.D.A., in a Sept. 7 statement.

Assured Bites, Hello, Peanut! kits for infants
Assured Bites offers Hello, Peanut! kits for infants.
 

The qualified health claim came in response to a petition filed by Assured Bites, Inc., Roslyn Heights, N.Y. The company offers Hello, Peanut! kits for infants.

Epidemiological evidence suggests the prevalence of peanut allergy in U.S. children at least doubled from 1997 to 2008, and peanut allergy is the leading cause of death related to food-induced anaphylaxis in the United States, according to the F.D.A. No F.D.A.-approved treatments for preventing or curing peanut allergy exist.

Scott Gottlieb, F.D.A.
Scott Gottlieb, M.D., commissioner of the F.D.A.

“As the incidence of peanut allergy grew, along with an awareness of the consequences, doctors began advising patients not to introduce peanut-containing foods to children under the age of 3 who were at high risk for peanut allergy,” Dr. Gottlieb said. “While this advice was well-intended, new evidence-based guidelines recommend that the medical community consider a different approach.”

The qualified health claim is based on one study involving more than 600 children between 4 months and 11 months of age who were enrolled in a Learning Early About Peanut Allergy (LEAP) study. All the infants were considered a high risk for developing peanut allergy because they had severe eczema and/or egg allergy. The study found regular peanut consumption achieved an 86% reduction in peanut allergy at age 5 among those who had negative skin prick tests to peanut at the study’s entry and a 70% reduction in peanut allergy among those who had positive tests.

The study, published Feb. 25, 2015, in The New England Journal of Medicine, may be found here.

Following the study, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, unveiled new peanut allergy guidelines in January of this year, saying the early introduction of peanut-containing foods to infants may prevent the development of peanut allergy.

Assured Bites in its petition included the LEAP study. Assured Bites sought a health claim for a substance containing peanut flour (ground whole peanuts) and oats. The substance is part of a seven-day introduction kit and maintenance kit where small amounts of peanut are introduced to infants and children. The quantity corresponds to the amount used in the LEAP study. The sachet of peanut flour is added to food, such as cereal, yogurt or applesauce.
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