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

By Megan Maisano,  Amanda Blechman & Dana Engel

On March 1, 2024, the U.S. Food and Drug Administration (FDA) announced the first-ever qualified health claim for yogurt. The claim identifies a potential link between regular yogurt consumption and a reduced risk of type 2 diabetes.

Background

Health Claims:^[1] In the United States, there are three label claims that are defined by statute and/or FDA regulations: health claims, nutrient content claims, and structure/function claims. Health claims specifically describe the relationship between a food, food component, or dietary ingredient and a reduced risk of a disease or health-related condition.

• Authorized Health Claims: Authorized health claims—that is, health claims defined and permitted by the Federal Food, Drug, and Cosmetic Act (FDCA)—must meet “significant scientific agreement” (SSA) standards or be based on authoritative statements from federal scientific bodies (21 U.S.C. § 343(r)(3)). Since 1990, FDA has authorized 12 health claims. One example of such a claim is the relationship between calcium, vitamin D, and osteoporosis (21 C.F.R § 101.72).
• Qualified Health Claims: Qualified health claims stem from emerging evidence that does not meet SSA standards. Unlike authorized health claims, qualified claims are not specifically provided for in the FDCA. In response to litigation that raised First Amendment challenges to the SSA standard, FDA announced its intention to exercise enforcement discretion for health claims that did not meet SSA but which are appropriately qualified to accurately reflect the science supporting the claim. Qualified health claims are not “approved” by FDA or published in the Code of Federal Regulations. Rather, in response to a petition submitted by a food manufacturer or other entity, FDA issues a letter of enforcement discretion describing FDA’s assessment of the science relevant to the claim and, if sufficient science exists, setting out specific qualified claim language for which FDA will exercise enforcement discretion. While the qualifying language reflects the limitations of the claim’s scientific evidence, it does not mean supporting scientific evidence does not exist or is not credible. To the contrary, FDA still requires that the totality of the body of evidence of good methodological quality must support the claim; the qualifications instead reflect that SSA is not yet achieved and that more research is warranted to further strengthen the claim.

Diabetes:^[2] Diabetes is one of the most significant and rapidly rising health conditions in the United States, affecting over 38 million Americans. It is characterized by the body’s inability to manage blood sugar. Type 1 diabetes is an autoimmune condition which stops the body from making insulin. Type 2 diabetes develops over time and results in the body’s inability to adequately produce and/or use insulin. Most Americans who live with diabetes, approximately 90–95%, have type 2 diabetes. Unlike type 1 diabetes, type 2 can be prevented or delayed with healthy lifestyle behaviors such as diet and exercise.

Yogurt’s Qualified Health Claim:^[3] The qualified health claim for yogurt is in response to a petition submitted by Danone North America in December 2018 and officially acknowledged by FDA in March of 2019 (Docket FDA-2019-P-1594). The petition cited a wide range of scientific publications identified by a comprehensive literature search which investigated the relationship between yogurt and reduced risk of type 2 diabetes. These publications included observational studies, human trials, meta-analyses, reviews, reports, and position statements. After reviewing the totality of the evidence, FDA identified 28 observational studies as sufficient to draw scientific conclusions about the proposed substance-disease relationship. For each of these studies, FDA rated the strength of the evidence based on study type, methodological quality, quantity, relevance, and replicability. On March 1, 2024, FDA announced in its letter of enforcement discretion that it intends to exercise enforcement discretion for use of specific qualified health claim language regarding the consumption of yogurt and reduced risk for type 2 diabetes.

FDA’s Letter of Enforcement Discretion

Qualifying Language:^[4] In its letter of enforcement discretion, FDA concluded there was some credible evidence for the relationship between yogurt and reduced risk of type 2 diabetes; as such, the agency described the evidence as “limited.” Therefore, the specific qualified health claim language for which FDA will exercise enforcement discretion is as seen below:

(1) “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.”

Qualifying Levels:^[5] Based on the scientific evidence, FDA considers “2 cups (3 servings) per week” to be the minimum amount to support the beneficial relationship between yogurt and reduced risk of type 2 diabetes. Therefore, this consumption criteria should be included in the claim as well.

Qualifying Nutritional Profile:^[6] FDA concluded that “the credible scientific evidence found a statistically significant association between risk reduction for type 2 diabetes and yogurt as a food, rather than any single nutrient or compound in yogurt, and irrespective of fat or sugar content.” Yogurt is a food defined by a standard of identity regulation (21 C.F.R. 131.200). Because the credible evidence is not associated with any particular fat or sugar content, the qualified health claim can be made for all dairy yogurts that FDA permits to be sold under the FDA’s standard of identity for yogurt.

Note that under FDA regulations 21 C.F.R. 101.14, health claims are not permitted for foods that exceed disqualifying levels of certain nutrients per the Reference Amount Customarily Consumed (RACC); specifically total fat (13 g), saturated fat (4 g), cholesterol (60 mg), and sodium (480 mg).¹² FDA determined that no exception from the disqualifying levels was needed for this qualified health claim. Therefore, a yogurt that exceeds any of these disqualifying thresholds is not eligible for this qualified health claim.

With respect to added sugar, there is currently no disqualifying level, with FDA noting that “the level of added sugar is not an enforcement discretion factor” for the claim. However, the agency “encourages careful consideration” for the use of this qualified health claim on products that could contribute significant amounts of added sugars to the diet given that Americans currently exceed recommended limits on added sugars.

Understanding the Evidence

The research analyzed in FDA’s review of this claim includes a variety of prospective observational cohort studies, the majority of which provide direct or suggestive evidence that yogurt consumption is associated with a lower risk of developing type 2 diabetes when measured over time.

Prospective observational studies are a critical tool in nutrition research because they allow scientists to study large groups of people in the real world and identify potential correlations between habits and health outcomes over a long period of time, often decades or more, without requiring people to alter their lives. Randomized controlled trials, which assign subjects to either a placebo or intervention group and attempt to control for all or most outside variables, are often considered the gold standard for determining causation over correlation. However, they can be difficult to design and carry out in a way that would allow comparison of a suitable control for a significant length of time. Many diseases, like type 2 diabetes, develop over time, making it difficult to observe this endpoint in a controlled intervention study.

Public Health Relevance

According to the Centers for Disease Control and prevention, there were 1.2 million new diagnoses of diabetes in 2021, and more than one in three Americans are currently at risk for type 2 diabetes.^[7] Furthermore, among children and adolescents, the overall incidence of type 2 diabetes significantly increased from 2002 to 2018.^[8] Diabetes increases the risk for health-related complications, lower quality of life, and early death. When it comes to prevention and management of type 2 diabetes, diet and lifestyle factors play a critical role.^[9]

Dairy foods, like yogurt, can provide important essential nutrients that contribute to multiple healthy dietary patterns, including those recommended by the Dietary Guidelines for Americans.^[10] Many yogurts offer a variety of essential nutrients including high-quality protein, calcium, phosphorus, riboflavin, pantothenic acid, vitamin B12, zinc, selenium, and iodine, as well as live and active cultures.^[11]

As previously discussed, FDA did not limit use of the claim based on levels of added sugar, though the agency did encourage careful consideration of whether to use the claim on products that could contribute significant amounts of added sugars to the diet.^[12] Although some yogurts are higher in added sugar than others, yogurt is not a primary contributor of added sugar in the American diet. According to the 2020–2025 Dietary Guidelines for Americans, the entire category of “higher fat milk and yogurt” is estimated to provide only 4% of the added sugar intake in Americans ages one and older, while other categories can contribute up to 24%.^[13]

Yogurt is nutritious on its own, and it’s also a useful vehicle for other nutrient-dense foods like fruit, seeds, nuts, and whole grains, which can help Americans consume nutrients of public health concern like calcium, vitamin D, potassium, and fiber. Furthermore, research shows that 90% of Americans don’t eat the recommended servings of dairy foods.^[14] Specifically, adults only consume about 0.07 servings of yogurt per day.^[15]

Conclusion

Health claims, like qualified health claims, offer an opportunity to provide consumers with information regarding the relationship between a food or food component and a health-related condition. Millions of Americans are either at risk or directly affected by type 2 diabetes. The new qualified health claim for yogurt can arm consumers with knowledge of its potential role in reducing the risk of type 2 diabetes.

 

[1] U.S. Food & Drug Admin., Label Claims for Conventional Foods and Dietary Supplements, https://www.fda.gov/food/food-labeling-nutrition/label-claims-conventional-foods-and-dietary-supplements  (content current as of June 19, 2018); U.S. Food & Drug Admin., Authorized Health Claims That Meet the Significant Scientific Agreement (SSA) Standard, https://www.fda.gov/food/food-labeling-nutrition/authorized-health-claims-meet-significant-scientific-agreement-ssa-standard (content current as of Jan. 12, 2018); U.S. Food & Drug Admin., Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (June 1998), https://www.fda.gov/food/guidance-documents-regulatory-information-topic/guidance-industry-notification-health-claim-or-nutrient-content-claim-based-authoritative-statement (content current as of Sept. 20, 2018); U.S. Food & Drug Admin., Guidance for Industry: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (July 2003), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-interim-procedures-qualified-health-claims-labeling-conventional-human-food-and (content current as of Sept. 20, 2018); U.S. Food & Drug Admin., Qualified Health Claims: Letters of Enforcement Discretion (Jan. 10, 2022), https://www.fda.gov/food/food-labeling-nutrition/qualified-health-claims-letters-enforcement-discretion.

[2] Centers for Disease Control, What is Diabetes?, https://www.cdc.gov/diabetes/basics/diabetes.html (Sept. 5, 2023); Centers for Disease Control and Prevention, National Diabetes Statistics Report, https://www.cdc.gov/diabetes/data/statistics-report/index.html (Nov. 29, 2023); Centers for Disease Control and Prevention, Diabetes, https://www.cdc.gov/globalhealth/healthprotection/ncd/diabetes.html (Dec. 5, 2021).

[3] U.S. Food & Drug Admin., RE: Petition for a Qualified Health Claim for Yogurt and Reduced Risk of Type 2 Diabetes Mellitus (Docket No. FDA-2019-P-1594), https://www.fda.gov/media/176608/download?attachment (Mar. 1, 2024); U.S. Food & Drug Admin., Docket ID: FDA-2019-P-1594-0003, https://www.regulations.gov/document/FDA-2019-P-1594-0003 (Apr. 11, 2019).

[4] FDA, RE: Petition for a Qualified Health Claim, supra note 3.

[5] Id.

[6] Id.; U.S. Food & Drug Admin., 21CFR131.200.B: Yogurt, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=131.200&SearchTerm=yogurt (Dec. 22, 2023); U.S. Food & Drug Admin., 21CFR101.14.A: Health claims: general requirements, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=101.14 (Dec. 22, 2023).

[7] CDC, National Diabetes Statistics Report, supra note 2; Centers for Disease Control and Prevention, Prediabetes – Your Chance to Prevent Type 2 Diabetes, https://www.cdc.gov/diabetes/prevention-type-2/prediabetes-prevent-type-2.html?CDC_AAref_Val=https://www.cdc.gov/diabetes/basics/prediabetes.html (Dec. 30, 2022).

[8] CDC, National Diabetes Statistics Report, supra note 2.

[9] Id.; CDC, Diabetes, supra note 2; CDC, Prediabetes, supra note 7.

[10] U.S. Dep’t of Agric. & U.S. Dep’t of Health & Hum. Servs., Dietary Guidelines for Americans, 2020–2025, 9th Edition, https://www.dietaryguidelines.gov/sites/default/files/2020-12/Dietary_Guidelines_for_Americans_2020-2025.pdf (Dec. 2020).

[11] National Dairy Council, Nine Ways Yogurt Can Help Your Body, https://www.usdairy.com/getmedia/3267370a-8b00-4bc9-b873-7feeba8cefa3/dairyinfographic_yogurt_v2%20pdf.pdf.pdf.aspx (2023); Dennis A. Savaiano & Robert W. Hutkins, Yogurt, Cultured Fermented Milk, and Health: A Systematic Review, 79 Nutrition Revs. 599 (Apr. 2020).

[12] FDA, RE: Petition for a Qualified Health Claim, supra note 3.

[13] USDA & HHS, Dietary Guidelines for Americans, supra note 10.

[14] Id.

[15] Christopher J. Cifelli, Kristin Fulgoni, Victor L. Fulgoni III & Julie M. Hess, Disparity in Dairy Servings Intake by Ethnicity and Age in NHANES 2015–2018, 7 Current Devs. Nutrition 100010 (Feb. 2023).