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FDA Approves First Qualified Health Claim about Allergy Prevention on Baby Food Labels

Last month, the FDA announced that companies will be able to label baby food products with advice about how the early introduction of peanuts in an infant’s diet may reduce the risk of developing a peanut allergy. This marks the first time the FDA has permitted a qualified health claim of food allergy prevention. These labels will be allowed on foods containing ground peanuts suitable for infant consumption, but not whole peanuts, which may be a choking hazard for young children.

The permitted qualified health claim states that “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.” In addition, the claim includes language that recommends that parents check with their child’s health care provider before introducing food that contains ground peanuts and discloses that the claim is based on one study.

The study, a clinical trial funded by the National Institutes of Health, found that introducing foods containing smooth peanut butter to babies as early as 4 months of age who are at high risk of developing a peanut allergy due to severe eczema, egg allergy, or both, may reduce their risk of developing peanut allergies later in childhood by about 80 percent.  As a result, the NIH issued new guidelines in early 2017 recommending that parents of infants with such risk factors introduce peanut-containing foods to their child’s diet as early as 4 to 6 months of age. The guidelines also advise parents to check with the child’s health care provider before introducing peanut-containing foods to determine if an allergy test should be administered and whether feeding should be done under a doctor’s supervision. The NIH’s recommendations have been supported by groups such as the American Academy of Pediatrics and the National Institute of Allergy and Infectious Diseases.

In permitting this new qualified claim, the FDA stated that its goal was to make sure parents are aware of the latest science so they can make informed decisions about these important issues in their children’s lives. According to the FDA’s announcement, around 2% of American children are allergic to peanuts, a figure that has more than doubled from 1997 to 2008. According to the announcement, peanut allergies are the leading cause of deadly food-induced anaphylaxis in the United States, and the majority of people who develop this allergy as children never outgrow it. The FDA noted that doctors had previously advised parents not to feed peanuts to children who were at high risk of developing a peanut allergy before age three, but that the NIH now recommends a “different approach.”  Companies have already begun making baby food specifically for the purpose of introducing infants to peanuts.

Now that the FDA has allowed one qualified allergy prevention claim on food labels, future evidence-based dietary recommendations may expand beyond peanuts and baby food. The prevalence and danger of food allergies in children, combined with the rapidly developing research on these subjects, make food labeling a particularly interesting space to watch.

© 2018 Proskauer Rose LLP.


About this Author

Lawrence I Weinstein, False Advertising and Trademark Copywright Law, Proskauer

Larry Weinstein is a Partner in Proskauer's Litigation Department. He is co-head of the firm’s Intellectual Property Litigation Group, and also co-head of the firm’s False Advertising & Trademark Practice. Larry is both a distinguished trial lawyer and counselor, whose practice covers a broad spectrum of intellectual property law, including Lanham Act false advertising and trademark cases, consumer class action cases, NAD and FTC proceedings, and trade secret and copyright litigations, as well as sports, art and other complex commercial cases.

Law Clerk

Evelyn Pang is a law clerk in the Litigation Department.

  • Columbia Law School, J.D., 2015

    Columbia Journal of Law & the Arts, Managing Editor

  • Brown University, B.A., 2011
    magna cum laude