For the first time, FDA has approved a food product label that makes a qualified claim about reducing an infant's risk of developing a peanut allergy.
Background on peanut allergies
The decision comes months after an expert panel sponsored by NIH's National Institute of Allergy and Infectious Diseases (NIAID) recommended that infants be exposed to peanut-containing foods before age 1 to help build a tolerance to peanuts. According to the panel, "peanut allergy is the leading cause of death related to food-induced anaphylaxis in the United States."
While other foods—including whole grains, nuts, and supplements—may carry qualified health claims saying they might reduce the risk of diseases such as cancer or heart disease, FDA previously had prohibited products from making such claims regarding allergies. According to the New York Times' "Well," qualified health claims indicate there is evidence in support of the claim but that evidence is not conclusive.
The product—Hello, Peanut—was developed by a physician and consists of organic peanut and blends of sprouted oats ground into a powder that can be mixed into puréed baby food to expose infants to peanuts beginning at about 5 months of age.
The product consists of a seven-pack introduction kit that is designed to gradually increase an infant's peanut exposure over a week-long period. After the first week, infants can be given so-called maintenance packets, which contain 2 grams of peanut powder. The maintenance packets can be used until a toddler is able to chew and swallow peanuts without choking or to eat peanut butter.
However, the label warns parents of high-risk infants, such as those with eczema or an egg allergy, to have their children evaluated by a physician and perform a skin or blood test before starting to use the product. If an infant develops an adverse reaction, such as hives, to the peanut powder when using the introduction kit, individuals should discontinue feeding the powder to the infant and contact a pediatrician.
The peanut powder is free of genetically modified organisms and certified organic, dairy-free, and kosher. The introduction kit costs $25, and the maintenance kit costs $20 for roughly three weeks.
Gottlieb in a statement said the NIH panel's recent recommendation change spurred the decision to allow the product to carry a qualified health claim. Gottlieb said, "The guidelines for how to approach allergens in children are changing, the science is changing, and it's important for parents to know."
FDA officials said other products that can build a person's tolerance for peanuts—such as smooth, creamy peanut butter and cereals—will be able to make same qualified claim as well, as long as the products fit the appropriate criteria.
David Erstein, the allergist who founded the company behind the powdered peanut butter product, Assured Bites, said he hopes the qualified health claim will make parents more comfortable with the revised recommendations and raise awareness around peanut allergies.
James Baker, chief executive of the patient advocacy group Food Allergy Research & Education, said it is important to reduce the development of peanut allergies, saying, "The easiest way to deal with a food allergy is to keep it from happening." However, he cautioned that the product is "not a treatment for peanut allergy and it's important that people understand that." Baker said, "If a child is allergic, they should not eat peanut under any circumstances."
Similarly, Lianne Mandelbaum, who runs a food allergy website, said, "The danger is that someone will misinterpret how to use this product and give it to a child who's already allergic," adding such a case "could be potentially dangerous" (Rabin, "Well," New York Times, 9/14; Gottlieb statement, 9/7).
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