FDA to allow limited claims that eating yogurt may reduce risk for type 2 diabetes
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The FDA said it will permit the use of two limited health claims that eating yogurt may reduce the risk for type 2 diabetes, according to a press release.
In a letter of enforcement discretion released March 1, the FDA responded to a health claim petition submitted on behalf of Danone North America. The petition asked the FDA to review a qualified health claim between the consumption of yogurt and reduced risk for type 2 diabetes for all types of yogurts that meet the FDA’s standard of identity. The petition also stated that scientific evidence supports the health effects of yogurt as a food rather than anything related to any single nutrient or compound.
After a review of the petition and the data presented within it, the FDA stated it intends to consider exercising enforcement discretion for two qualified health claims between yogurt and a reduced risk for type 2 diabetes. The two qualified health claims are:
- Eating yogurt regularly, at least two cups (three servings) per week, may reduce the risk for type 2 diabetes. FDA has concluded that there is limited information supporting this claim.
- Eating yogurt regularly, at least two cups (three servings) per week, may reduce the risk for type 2 diabetes according to limited scientific evidence.
Some studies find yogurt lowers type 2 diabetes risk
According to the FDA’s response letter, Danone North America’s petition cited 117 publications as evidence to support its proposed claims, including 50 observational studies; 33 human intervention studies; 11 reviews; eight meta-analyses; nine publications related to nutrition, dietary intake and validation of dietary assessment tools; three reports; two position statement; and one methodological study.
The FDA based its response on a review of 28 observational studies that reported on the relationship between yogurt consumption and type 2 diabetes. Most of the studies assessed yogurt intake through a food frequency questionnaire. Endpoints consisted of incidence of type 2 diabetes or validated endpoints for type 2 diabetes such as fasting blood glucose alone or as a component of metabolic syndrome, impaired glucose metabolism, HbA1c and prediabetes alone or in combination with insulin resistance.
Of the studies the agency reviewed, nine were described as being of a high methodological quality. Among those nine studies, six examined associations between yogurt intake and type 2 diabetes risk. A reduced risk for type 2 diabetes with yogurt consumption was found among three prospective cohort studies from Spain as well as from the Nurses’ Health Study and the Women’s Health Study cohorts in the U.S. However, data from the Nurses’ Health Study II and the Health Professionals Follow-up Study cohorts found no link between eating yogurt and type 2 diabetes risk. There were three high-quality studies that assessed the effect of change in yogurt intake on risk for type 2 diabetes. The FDA stated the findings among those studies were inconsistent.
No link observed in most moderate-quality studies
The remaining 19 studies included in the review were deemed to be moderate in quality. The FDA said findings were inconsistent among four cross-sectional studies. Of 10 moderate-quality studies that assessed incidence of type 2 diabetes, four found yogurt reduce the risk for type 2 diabetes. No associations were observed between yogurt and endpoints of type 2 diabetes among six moderate-quality observational studies.
The FDA stated scientific conclusions could not be drawn from the intervention studies included in the petition as they “were not sufficiently controlled to provide useful information for assessment of a health claim.” The FDA also did not include the human intervention studies, reviews, meta-analyses and other background reports in its review.
“Based on the findings of these 28 observational studies, FDA concludes that there is some credible evidence supporting a relationship between yogurt intake and reduced risk of type 2 diabetes,” the FDA’s response letter stated. “As noted in the petition, the credible scientific evidence found a statistically significant association between risk reduction of type 2 diabetes and yogurt as a food, rather than any single nutrient or compound in yogurt, and irrespective of fat or sugar content. However, this evidence is based exclusively on observational studies which, despite controlling for relevant covariates, cannot exclude residual confounding due to unknown or unmeasured confounders. Consequently, observational studies measure associations instead of a cause-and-effect relationship between a substance and disease. Furthermore, the study findings were inconsistent. Most of the statistically significant associations between yogurt intake and reduced risk of type 2 diabetes were observed among the high methodological quality studies; however, most of the moderate-quality studies did not observe a statistically significant association.”
Reference:
FDA. RE: Petition for a qualified health claim for yogurt and reduced risk of type 2 diabetes mellitus (Docket No. FDA-2019-P-1594). Available at: https://www.fda.gov/media/176608/download?attachment. Published March 1, 2024. Accessed March 4, 2024.
Perspective
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Susan Weiner, MS, RDN, CDN, CDCES, FADCES
The FDA has stated there is some evidence, however, not significant scientific agreement, that eating at least two cups of yogurt per week may reduce the development of type 2 diabetes. This announcement followed a petition from Danone North America, whose brands include Dannon and Activia, for a qualified health claim. The approved claim does not qualify or address the specific contents of yogurt, including sugar or carbohydrate content.
Qualified health claims address a food or substance relationship to a disease but do not necessarily meet the higher standard for an authorized health claim. The “yogurt” claim included information from observational studies of participants over time and found a link between eating yogurt and a lower risk of type 2 diabetes. Observational studies do not necessarily prove a causal relationship between eating a particular food and disease risk. This is an important point for consumers who must read beyond the headlines and understand that type 2 diabetes cannot be prevented by simply eating yogurt.
The FDA has allowed qualified health claims for dietary supplements since 2000 and foods since 2002. A qualified health claim lacks full scientific support but is allowed with disclaimers included to help prevent misleading consumers. These types of health claims are rarely announced. Over the past decade, only 10 foods have been allowed to be sold with qualified health claims. Examples include consuming some types of cocoa may reduce heart disease and cranberry juice consumption may reduce the risk of recurrent urinary tract infections for women.
Consumers must be cautioned that the approved label claim is not based on gold-standard randomized controlled trials that could have potentially shown whether yogurt reduces type 2 diabetes risk. There is no one food that can reduce disease risk, including yogurt. Additionally, many yogurts are packaged with toppings such as candy, cookies, honey and sweetened cereal, all containing sugar and large amounts of carbohydrate. There are multiple studies which show that significant consumption of added sugars may increase type 2 diabetes risk. Clarity is key for consumers, especially since there are so many varieties of yogurts available, many of which are packaged with a side offering of low nutrient dense, high sugar added companion toppings.
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