The US Food and Drug Administration (FDA) recently announced in a letter of enforcement discretion its decision not to challenge certain qualified health claims regarding the consumption of yogurt and reduced risk of type two diabetes if the claims are not misleading and comply with other regulatory requirements.
In general, a health claim describes the link between a substance and its impact on health or disease (e.g., sodium and hypertension). To be approved by the FDA as an authorized health claim, there must be significant scientific agreement (SSA) among qualified experts that the claim is supported by the totality of publicly available scientific evidence for a substance/disease relationship. By contrast, a qualified health claim, while backed by scientific evidence, does not meet the stringent SSA standard for an authorized health claim and must include specific qualifying language.
New Qualified Health Claim
The FDA’s letter of enforcement discretion addresses a petition that sought the agency’s evaluation of a health claim linking yogurt consumption with a lower risk of type two diabetes. The petition, which pertained to all yogurt varieties meeting the FDA’s standard of identity, emphasized that the health benefits of yogurt products are attributable to their overall food profile, rather than any specific nutrient or compound, and are therefore not dependent on the products’ fat or sugar content.
The FDA’s decision means that yogurt products that meet the agency’s standards of identity for yogurt at 21 C.F.R. § 131.200 may include on their labeling either version of the following qualified health claim related to a reduced risk of type two diabetes:
- “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.”
To use the qualified health claim, yogurt products must not exceed the general disqualifying nutrient levels for total fat, saturated fat, cholesterol, or sodium set in regulation at 21 C.F.R. § 101.14(e)(3). Notably, the qualified health claim statement must identify two cups (three servings) of yogurt per week as the minimum consumption level.
Key Takeaways
The FDA concluded that the credible scientific evidence showed a statistically significant association between reduced risk of type two diabetes and yogurt as a food, irrespective of fat or sugar content. In addition, the FDA has not set a disqualifying nutrient level for added sugars in its regulations. As such, the agency stated that the level of added sugars is not an enforcement discretion factor for a qualified health claim regarding the relationship between yogurt and type two diabetes.
Companies that intend to market or label their yogurt products with the qualified health claim should consider carefully reviewing the FDA’s letter of enforcement discretion to ensure their products meet all requirements.
Further, companies should consider carefully tailoring their marketing claims to ensure they do not exceed the scope of the sanctioned qualified health claim. Although the US Federal Trade Commission gives deference to a determination by the FDA on whether there is adequate support for a particular health claim, the Commission stated in its Health Products Compliance Guidance that it intends to focus on the clear and conspicuous disclosure of limitations for claims based on emerging science.