Earlier this month, the U.S. Food and Drug Administration announced that it would allow infant food manufacturers to use a qualified health claim on their labeling to characterize the relationship between consumption of ground peanuts by infants beginning between 4 and 10 months of age and a reduced risk of developing peanut allergy by age five. The precise language FDA will allow reads:
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. FDA 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 healthcare provider before feeding foods containing ground peanuts.
Qualified health claims must be supported by credible scientific evidence, a less rigorous standard than the “significant scientific agreement” requirement for authorized health claims. Here, FDA found support for the qualified claim in the same studies that moved the National Institute of Health to issue updated guidelines for the early introduction of peanut-containing foods in infants.
FDA’s decision is notable for several reasons. First, it was the first time the agency approved a health claim aimed at preventing a food allergy. FDA acknowledges that food allergies are an increasing and serious public health issue that requires the agency’s attention. This is one of many tools it has available to address the problem.
Second, it showed the FDA’s willingness to loosen restrictions on allowable disease prevention claims within its existing regulatory framework when presented with sound, scientific evidence demonstrates. In this case, the agency was responding to a manufacturer’s petition.
Third, it showed FDA Commissioner Scott Gottlieb’s willingness to step into the role of the nation’s doctor. FDA’s announcement was accompanied by a statement from Dr. Gottlieb, in which he addressed concerns about food allergies and possible prevention as both a parent and physician. He has spoken similarly on other public health issues, most recently on the opioid addiction crisis, and thus has demonstrated a willingness to encroach on questions traditionally in the realm of the practice of medicine, an area the agency typically avoids.
Achieving regulatory changes in the current political environment is challenging, but this decision demonstrates that FDA will respond to requests based on sound scientific evidence to relax rules that otherwise limit what manufacturers can say about their products. Manufacturers whose products show demonstrable health benefits may thus want to consider similar requests to secure greater marketing flexibility.