FDA Qualified Health Claims for Yogurt and Type 2 Diabetes

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FDA Announces Qualified Health Claim for Yogurt and Reduced Risk of Type 2 Diabetes

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Friday, March 1, 2024

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On March 1, 2024, the U.S. Food and Drug Administration (FDA) announced in a letter of enforcement discretion that it does not object to the use of certain qualified health claims regarding the consumption of yogurt and reduced risk of type 2 diabetes, provided that the qualified health claims are worded so as not to mislead consumers, and that other factors for the use of the claim are met.
A health claim characterizes the relationship between a substance and a disease or health-related condition. A qualified health claim is supported by scientific evidence, but does not meet the more rigorous “significant scientific agreement” standard required for an authorized health claim.
The letter is in response to a petition submitted on behalf of Danone North America that requested the Agency to review this qualified health claim. The petition also noted that the evidence supports the health effects of yogurt as food rather than related to any single nutrient or compound and thus is independent of fat and sugar content. FDA determined that there is some credible evidence supporting a relationship between yogurt intake and reduced risk of type 2 diabetes, but this evidence is limited.
FDA considers 2 cups (3 servings) per week of yogurt to be the minimum amount for this qualified health claim. FDA intends to consider exercising its enforcement discretion for the following qualified health claims regarding the relationship between yogurt and reduced risk of type 2 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.”