FDA approves first-of-kind qualified health claim for peanut allergy prevention

11-Sep-2017 - Last updated on 24-Jan-2024 at 14:40 GMT

Recognizing that introducing peanuts to potentially allergic infants is a “significant concern among new parents,” FDA approved a new qualified health claim that reiterates and reassures parents of new advice to give 4- to 10-month-olds products containing peanut to reduce their risk of developing an allergy to the ingredient, according to the agency.

The qualified health claim also adds “legitimacy” to a new segment of peanut-containing infant products, said David Erstein, founder of Assured Bites, which makes the step-based introductory peanut product Hello, Peanut!

Assured Bites also is the company that sought the QHC from FDA, a decision Erstein told FoodNavigator-USA was made “to strengthen our legitimacy with parents and the general public that there is something available that is scientifically proven to help protect their infants” from developing a potentially life-threatening peanut allergy.

“We felt as if without an FDA approval to our health claim, the benefits of early introduction would not be clear to parents. We also knew there would continue to be an uphill challenge informing and convincing the public and health professionals that early introduction of peanuts was absolutely the right thing to do,” he said.

Parents’ resistance to the advice is understandable given it directly contradicts what previous generations were told, FDA Commissioner Scott Gottlieb said in a statement announcing the QHC.

“Perhaps one of the most challenging decisions for parents of my generation is when and how to introduce foods that pose a potential for a significant allergic reaction. Those decisions are made more difficult as the prevalence of certain food allergies appear to be on the rise,” such as peanut allergies which have more than doubled in children from 1997 to 2008 alone, he said.

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

Citing a clinical trial that Assured Bites included in its petition for the QHC, Gottlieb noted that introducing smooth peanut butter to babies as early as four months of age who are at high risk of developing a peanut allergy reduces their risk of actually developing the allergy later in childhood by 80%.

“As the science of governing allergies and diets continues to evolve, so do expert recommendations around how best to safely introduce babies and children to various foods,” Gottlieb said. As such, he noted the National Institutes of Health issued new guidelines in January recommending parents and infants with severe eczema, egg allergy or both introduce peanut-containing products to children as early as 4 to 6 months of age.

With this in mind, FDA acquiesced to Assured Bites’ petition for a qualified health claim stating “for most infants with severe eczema and/or egg allergy who are already eating solid foods, introducing foods containing ground peanuts between four and 10 months of age and continuing consumption may reduce the risk of developing peanut allergy by 5 years of age.”

The new claim will appear next to allergen-warnings and recommend that parents check with their child’s healthcare provider before introducing foods containing ground peanuts. It will also note that the claim is based on one study, according to FDA.

That study is the Learning Early about Peanut Allergy (LEAP) study, which was inspirational in the creation of Hello, Peanut! Introduction System, which allows parents to gradually and methodically increase the amount of peanut their child consumes over a seven-day period.

While there are other peanut products, such as puffs, available for infants, Hello, Peanut! offers a methodical approach that can calm parents’ fears, Erstein told FNU when the product first launched in March 2016.

Since then, Erstein says the company has received an “overwhelmingly positive response” to Hello, Peanut!

“We have received countless letters from parents thanking us for making peanut introduction easy, healthy and safe. Even the parents of infants that had concern for peanut introduction for their high-risk infants, after clearance from their pediatrician to start peanut introduction, they felt our introductory approach made the whole process easier and less anxiety provoking,” he said, adding, “I think the AHC will only help improve our overall message and goal to help prevent peanut allergy.”