FDA Will Not Object to Qualified Health Claims for Yogurt for Type 2 Diabetes Risk Reduction

Lessons Gleaned from FDA’s Letter of Enforcement Discretion

On March 1, 2024, the U.S. Food and Drug Administration (FDA) issued a letter of enforcement discretion¹ concluding that it will not object to the use of the following qualified health claims regarding yogurt consumption 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.”²
• “Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes according to limited scientific evidence.”³

The qualified health claim statement must identify 2 cups (3 servings) of yogurt per week as the minimum consumption level.

Background

Qualified health claims provide a way for manufacturers to communicate potential health benefits of their products, even when the scientific evidence does not meet the stringent criteria required for authorized health claims. These claims must be accompanied by qualifying language to ensure they do not mislead consumers.

FDA’s Decision on Yogurt and Type 2 Diabetes

The FDA’s letter of enforcement discretion states that it will not object to the qualified health claims on yogurt labels. This decision came in response to a petition from Danone North America, which cited 117 publications in support of the claim. The FDA’s determination was based on a comprehensive review of 28 observational studies, which provided the most relevant scientific evidence for drawing conclusions.

The FDA issued this letter in response to a petition submitted on behalf of Danone North America that asked the FDA to review potential qualified health claims it wished to place on yogurt labels. Danone North America’s brands include Dannon, Activia, Oikos and Silk, among others,⁴ but the petition covered all types of yogurt that meet the FDA’s standard of identity of yogurt as a food, containing various levels of fat and sugar.

Qualified health claims are health claims which do not satisfy the more rigorous “significant scientific agreement” standard necessary for an authorized health claim, and, as such, must be accompanied by qualifying language to prevent misleading consumers and to convey the level of scientific evidence supporting the claim.⁵

The FDA does not “approve” qualified health claim petitions. Instead, the FDA issues a letter of enforcement discretion to food manufacturers who have petitioned the FDA for the use of a qualified health claim. The letter includes language indicating the level of scientific support for the evidence and specifics of all enforcement discretion factors under which the FDA will not object to the use of the qualified health claim.⁶

After reviewing the scientific evidence and other information submitted in the petition, the FDA concluded that “current scientific evidence is appropriate for consideration of qualified health claims for consumption of yogurt and reduced risk of Type 2 diabetes, provided that the qualified health claims are appropriately worded to avoid misleading consumers.”⁷

In the letter, the FDA describes the basis for evaluating the scientific evidence and the factors that the FDA intends to consider in exercising its enforcement discretion for the qualified health claims related to yogurt consumption and reduced risk of Type 2 diabetes. FDA letters of enforcement discretion, such as this one, hold important lessons on how the FDA evaluates scientific evidence and qualified health claims, with applications not only for manufacturers interested in making health claims but also for anyone interested in understanding FDA’s process of weighing scientific evidence.

FDA’s Approach to Evaluating Qualified Health Claims

Health claims describe the relationship between a substance and a disease/condition. After identifying the substance, the disease/condition and the targeted population, the FDA considers the data/information provided in the petition as well as other available information to determine if the relationship has support.

Key evaluation criteria:

• Study Design: Preference for interventional studies with random assignments.
• Quality of Evidence: Consideration of the methodological quality of studies.
• Consistency: Replication of results and consistency across studies.
• Population: Applicability to the entire U.S. population or specific subgroups.

The FDA concluded that while there is some credible evidence supporting the claim, it is limited and should be clearly communicated as such to prevent consumer deception.

The FDA’s focus is on human studies. Although it also considers other types of scientific literature such as meta-analyses, review articles, animal and in vitro studies, the FDA notes that these other types of scientific literature “cannot by themselves support a health claim relationship.”⁸ The FDA explains that meta-analyses and review articles lack sufficient information/detail on the individual studies reviewed in these publications. Instead, the FDA generally uses meta-analyses and review articles as background and to identify individual study publications to evaluate further. Similarly, the FDA uses animal and in vitro studies as background on potential mechanisms of action, but notes these types of studies “can be used to generate hypotheses or to explore a mechanism of action but cannot adequately support a relationship between the substance and the disease.”⁹

The FDA rates the methodological quality of the human studies, based on study design, data collection, quality of the statistical analysis, type of outcome measured and other factors such as selection bias and additional information gathered and reported about participants. The FDA then evaluates the totality of the scientific evidence, rating the strength of the total body of publicly available evidence based on study type (noting that the strongest evidence is interventional studies where participants are randomly assigned to an intervention or no intervention), the previously-assigned methodological quality rating, evidence quantity (including number of studies of each type as well as sample sizes of the studies), whether the health claim is supported for the entire U.S. population or a subgroup, whether the studies have been replicated, and the overall consistency of the total body of evidence. Therefore, “[b]ased on the totality of the scientific evidence,”¹⁰ the FDA determines the credibility of the evidence to support a qualified health claim and the qualifying language needed to express the limits of the scientific evidence or to prevent the claim from being misleading.

FDA’s Conclusions on Qualified Health Claims on Yogurt for Type 2 Diabetes Risk Reduction

In evaluating qualified health claims regarding yogurt consumption and reduced risk of Type 2 diabetes, the FDA concluded that “there is some credible evidence supporting a relationship between yogurt intake and reduced risk of Type 2 diabetes”¹¹ based exclusively on the 28 observational studies. The FDA noted that observational studies, even when well-controlled for covariates, cannot exclude residual confounding due to unknown confounders. As such, “observational studies measure associations instead of a cause-and-effect relationship.”¹² The FDA also explained that most of the statistically significant associations were reported in the high methodological quality studies while the majority of the moderate quality studies did not find a statistically significant association. Therefore, the FDA concluded that the “evidence is limited”¹³ and that qualifying language should be included to convey this.

In order to qualify the level of yogurt needed to achieve the claimed effect, the FDA evaluated six observational studies rated as high methodological quality. The lowest amount necessary to achieve the effect — 2 cups (3 servings) per week — was based on two large U.S. prospective cohort studies.

The FDA also clarified that it would not object to the qualified health claim on yogurts that do not exceed the disqualifying nutrient levels for total fat, saturated fat, cholesterol and sodium set forth in 21 CFR 101.14(a)(4). The FDA has not established a disqualifying level for added sugars and, therefore, added sugars is not an enforcement discretion factor for the qualified health claim on yogurt, meaning added sugars in yogurt would not impact FDA’s exercise of enforcement discretion here. However, the “FDA encourages careful consideration of whether to use the claim on products that could contribute significant amounts of added sugars to the diet.”¹⁴

Lastly, the FDA noted that in the future, if new scientific evidence is submitted, the FDA would evaluate that evidence to determine if a change in its decision is needed.

Regulatory Landscape and Future Outlook

The reasoning the FDA provides in this and other letters of enforcement discretion holds lessons for stakeholders who are considering adding health claims to their products as well as for anyone interested in gaining insight into how the FDA evaluates scientific evidence. Companies that plan to market or add labeling to their yogurt products with the qualified health claims should carefully review the FDA letter of enforcement discretion and confirm that their products meet all requirements (e.g., no exceedance of disqualifying nutrient levels).

The FDA’s decision provides valuable insights into its process for evaluating scientific evidence and issuing qualified health claims. This approach aligns with broader regulatory trends emphasizing transparency and evidence-based evaluations.

Manufacturers should monitor ongoing research and be prepared to update their claims if new evidence emerges. Understanding the FDA’s criteria and maintaining compliance with regulatory standards is crucial for leveraging qualified health claims effectively. Stakeholders should review FDA guidelines to ensure all products meet the required nutrient levels and consumption guidelines, keep abreast of new scientific studies and potential regulatory changes, and clearly convey the qualified health claims on product labels without misleading consumers. Upholding the highest standards in product formulation and marketing practices is essential to earning and sustaining consumer trust.