FDA recommends early introduction to peanuts to prevent allergies

The FDA issued an FDA Modernization Act health claim on Dec. 8 acknowledging the safety of the early introduction of peanuts among infants to reduce the risk for developing peanut allergy.

Manufacturers may now use claims that the introduction of age-appropriate, peanut-containing foods to infants aged as young as 4 months with severe eczema, egg allergy or both may reduce risk for developing peanut allergy.

However, the FDA continued, these claims also must tell caregivers that they should check with their baby’s health care provider before feeding their baby these foods.

This claim follows a 2017 statement from the FDA linking early peanut introduction and reduced risk for developing a peanut allergy.

Lisa Gable, MA, CEO of Food Allergy Research & Education (FARE), told Healio that her organization applauds the FDA’s decision.

“What’s great about the new FDAMA health claim is that it demonstrates support of the Dietary Guidelines for Americans 2020-2025 recommendation that people should introduce food allergens early in the diets of infants, beginning around 4 months of age, to reduce the risk [for] developing food allergies,” Gable said.

The LEAP Study

The FDA based its decision on the results of the 2015 Learning About Peanut Allergy (LEAP) study, Gable continued, a randomized trial inspired by the dramatically lower prevalence of peanut allergy among babies and infants in Israel.

Lisa Gable

“Israeli babies routinely consumed peanut in the form of a corn puff called Bamba. But in the United States and United Kingdom, where people were avoiding giving peanut-based foods to babies and children, there was much higher prevalence [of peanut allergy],” Gable said.

The prevalence of food allergies began to increase in the late 1990s, Gable said, as pediatricians and allergists told parents to avoid feeding proteins that could trigger allergic reactions to their young children.

“We now understand that avoidance was actually the wrong thing to tell families, because the early introduction of allergens helps train the child’s immune system,” Gable said, adding that early introduction should begin between 4 to 6 months of age.

FARE helped fund the LEAP study, which followed 640 children for more than 4 years. Babies enrolled in the study were believed to already be at high risk for developing peanut allergy because they already had severe eczema, egg allergy or both.

Beginning between age 4 to 10 months, one group received age-appropriate peanut foods several times a week, and the group other did not.

“The results were dramatic,” Gable said. “By 5 years of age, the children who had eaten peanut foods starting in infancy were 80% less likely to develop a peanut allergy than children who avoided eating peanuts through early childhood.”

The SEED study

FARE is now turning its attention beyond peanuts and toward other allergens by funding the Start Eating Early Diet (SEED) study, which will involve about 2,000 infants and the introduction of milk, egg, peanuts, cashew, walnuts, almonds, soy and sesame.

“If the hypothesis proves to be true, the early introduction of all proteins may result in a drop in food allergies developing,” said Gable. “We’re very excited about any conversation because we all want to see the prevalence of food allergies decrease.”

The multi-year SEED study will be based on work by Ruchi S. Gupta, MD, MPH, director of the Institute for Public Health and Medicine – Center for Food Allergy and Asthma Research at Northwestern University Feinberg School of Medicine.

“Dr. Gupta, who is an epidemiologist and pediatrician at Northwestern University, received a grant from the NIH to do an introduction study with peanuts and 10,000 babies, so that study is well underway,” Gable said.

“What we’re basically doing in this study is leveraging Dr. Gupta’s work, and testing the hypothesis about whether or not the introduction of other allergens has the same result,” Gable added.

Community outreach

Buoyed by these results, FARE offers resources to families and health care providers alike to encourage them to introduce allergens to children early to prevent food allergies.

“Doctors, pediatricians and physicians’ assistants should go to foodallergy.org to see more information,” Gable said. “Babiesfirst.org also features a lot of information focused on the concept of early introduction of foods to babies, including the results of the LEAP study.”

FARE additionally offers audience-friendly videos including the stories of families who have been practicing early introduction, as well as webinars.

Plus, FARE is working with Congress and the Biden administration to incorporate its food allergy findings into the federal Special Supplemental Nutrition Program for Women, Infants and Children (WIC).

“We are really focused on making sure that as we get the conclusions of these studies, the findings are incorporated into the WIC program so all babies will have the opportunity to avoid food allergies through the introduction of proteins,” Gable said.

Gable is optimistic too, noting a recent Australian study showing a 16% decrease in peanut allergy prevalence following the 2016 publication of infant feeding guidelines in Australia recommending introduction to peanuts before age 12 months.

“If we follow the way of the Australians and get the information out to all Americans, we are really hoping to see fewer and fewer American children with peanut allergy,” she said.

“Right now, two children in every classroom and about 6 million children nationwide are developing allergies,” she continued. “If this study can make the difference in the lives of young children and get them healthier as well as keeping them safe, that’s what we’re all about.”

For more information:

Lisa Gable, MA, can be reached at media@foodallergy.org.

References:

• Du Toit G, et al. N Engl J Med. 2015;doi:10.1056/NEJMoa1414850.
• FDA completes review of a notification regarding a health claim related to peanut allergies. https://www.fda.gov/food/cfsan-constituent-updates/fda-completes-review-notification-regarding-health-claim-related-peanut-allergies. Published Dec. 8, 2021. Accessed Dec. 20, 2021.
• Soriano V, et al. Abstract L5. Presented at: American Academy of Allergy, Asthma & Immunology; Feb. 26-March 1, 2021 (virtual meeting).
• Statement by Lisa Gable, CEO of FARE: Regarding FDA’s Dec. 8, 2021 notification letter announcing a FDAMA health claim on early introduction of peanuts to reduce the risk of developing peanut allergy. https://www.foodallergy.org/media-room/statement-lisa-gable-ceo-fare-regarding-fdas-dec-8-2021-notification-letter-announcing. Published Dec. 9, 2021. Accessed Dec. 20, 2021.