• 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 CFR 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 July 24, 2017, the FDA announced that the Agency would permit the use of a qualified health claim regarding the relationship between consumption of macadamia nuts and a reduced risk of coronary heart disease (CHD) despite the nuts being above the typically permitted level of fat and below the typically required levels of nutrients. FDA has typically required foods bearing CHD-related health claims to be low in saturated fat and low in cholesterol, and to meet the definition of a “low fat” food as defined under FDA’s labeling requirements. In this case, however, citing to macadamia nuts’ favorable (5:1) unsaturated to saturated fat ratio, and the fact that these nuts contain potentially beneficial substances such as dietary fiber and phytosterols, FDA found that a qualified health claim about macadamia nuts and reduced risk of CHD might assist consumers in maintaining a healthy diet. The claim permitted for use by the FDA is:
    • “Supportive but not conclusive research shows that eating 1.5 ounces per day of macadamia nuts, as part of a diet low in saturated fat and cholesterol and not resulting in increased intake of saturated fat or calories may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content.”
  • FDA’s decision to permit a qualified health claim for macadamia nuts follows on the Agency’s interim final rule (81 FR 91716) published in December 2016 (previously discussed on this blog) to amend 21 C.F.R. 101.75 to expand the use of heath claims concerning the relationship between dietary saturated fat and cholesterol and risk of CHD to certain raw fruits and vegetables that were previously ineligible to make the claim. The December 2016 interim final rule together with FDA’s response to the macadamia nut petition could signal the Agency’s willingness, going forward, to exercise its enforcement decision to permit qualified health claims for foods with similar nutrition profiles.