• A health claim characterizes the relationship between a substance and its ability to reduce the risk of a disease or health-related condition (see 21 C.F.R. 101.14). A health claim must contain the elements of a substance and a disease or health-related condition. In addition, health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease. Health claims are required to be reviewed and evaluated by FDA prior to use via a petition process. There are two types of health claims: (1) health claims that meet the standard of significant scientific agreement (SSA) and (2) qualified health claims.
  • A qualified health claim does not meet the “significant scientific agreement” standard. Therefore, the FDA requires qualified health claims to be accompanied by qualifying language or a disclaimer communicating the level of scientific evidence supporting the claim. Qualified health claims are currently evaluated under FDA’s interim guidance for such claims. FDA issues letters of enforcement discretion when there is credible evidence to support a qualified health claim. For a food to bear a qualified health claim, it is required to be low in fat and contain 10% or more of the Reference Daily Intake or the Daily Reference Value of the nutrients specified in 21 C.F.R. 101.14(e)(6) (i.e. vitamin A, vitamin C, iron, calcium, protein, or fiber per RACC).
  • On September 7, 2017, the FDA announced that the Agency intends to exercise enforcement discretion for the use of a qualified health claim for infants with severe eczema and/or egg allergy characterizing the relationship between the consumption of foods containing ground peanuts beginning between 4 and 10 months of age and a reduced risk of developing peanut allergy by 5 years of age. The claim, which manufacturers can use immediately, 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.”
  • FDA Commissioner Scott Gottlieb released a statement highlighting the Agency’s decision and noting that the FDA will continue to monitor the research related to peanut allergy and, if new scientific information emerges, FDA will evaluate whether the claim should be updated.