In general, health claims in food labeling are intended to show that a food or food component may reduce the risk of a disease or health-related condition. Health claims must be approved by the FDA and must be supported by significant scientific agreement (“SSA”) among qualified experts that the claim is supported by the “totality of publicly available evidence” for a relationship between the food and disease. Unlike an authorized health claim, qualified health claims do not need to meet the SSA standard of evidence but must be accompanied by a disclaimer that accurately communicates to consumers the level of scientific evidence that supports the claim.   

The recent letter of enforcement discretion was issued in response to a petition requesting that FDA review evidence supporting the use of a qualified health claim regarding the relationship between the consumption of yogurt and a reduced risk of type two diabetes for all types of yogurt meeting FDA’s standards of identity. You can find our prior discussion of FDA’s different standards of identity for yogurt here. Significantly, the petition argues that the evidence supporting these health effects are based on yogurt’s food profile as a whole and are not based on an ingredient or component of yogurt. Thus, these claims should be used for any type of yogurt product regardless of the sugar or fat content.

FDA ultimately agreed with this argument as well as the evidence provided but noted that the available evidence is “limited” and issued additional restrictions to be used when asserting this qualified health claim. First, FDA considers 2 cups or 3 servings of yogurt per week to be the minimum consumption level required for the use of this claim.  Second, the yogurt product may not exceed any of the disqualifying nutrient levels for total fat, saturated fat, cholesterol, or sodium established under 21 C.F.R. § 101.14(a)(4). Notably, FDA has not set a disqualifying nutrient level for added sugars by regulation and therefore the level of added sugars in a yogurt product will not trigger FDA’s enforcement discretion related to this health claim. Finally, any yogurt product bearing the qualified health claim on its product labeling must still meet at least 10 percent of the Daily Value of certain nutrients (such as vitamin A, vitamin C, calcium, and iron) under 21 C.F.R. § 101.14(e)(6).

FDA’s decision authorizes marketers of yogurt products that meet FDA’s standards of identity at 21 C.F.R. § 131.200 to include the following qualified health claims on their product labeling:

• “Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes. FDA has concluded that there is limited information supporting this claim.”
• “Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes according to limited scientific evidence.”

Companies intending to market their products with the qualified health claim should carefully review their product labeling in order to ensure compliance with FDA’s letter of enforcement discretion. Companies should also be mindful of the US Federal Trade Commission’s (“FTC”) Health Products Compliance Guidance when marketing products with health claims as this guidance outlines the requirements for properly disclosing limitations related to health claims.

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