FDA Allows a Qualified Yogurt and Type 2 Diabetes Claim (2024)

Table of Contents

1. What the FDA Did
2. What a Qualified Health Claim Is
3. The Petition and the Public Comments
4. Which Yogurts the Claim Covers
5. How the FDA Screened the Evidence
6. What the Remaining Studies Found
7. Where “2 Cups (3 Servings) per Week” Comes From
8. The Wording the FDA Will Not Object To
9. Label Conditions: Fat, Sodium, Added Sugars and Nutrient Minimums
10. What the Decision Does Not Do
11. Dates and Legal Status as of October 11, 2026
12. How the Decision Fits Other FDA Labeling Actions
13. Primary Documents
14. Key Research Papers
15. Connections

1. What the FDA Did

The FDA Human Foods Program published a constituent update dated 1 March 2024, “FDA Announces Qualified Health Claim for Yogurt and Reduced Risk of Type 2 Diabetes.” It states that the agency “announced today in a letter of enforcement discretion that it does not intend to 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.”

The letter itself, also dated 1 March 2024, answers a petition filed in public docket FDA-2019-P-1594. It was issued by the Center for Food Safety and Applied Nutrition and signed by Claudine Kavanaugh, PhD, MPH, RD, Director of the Office of Nutrition and Food Labeling. It sets out the agency’s scientific review, its conclusion that the evidence is limited, the minimum amount of yogurt a claim must state, and the label conditions under which the agency intends to consider using its enforcement discretion.

A docket is the public file the government opens for a petition or rule; anyone can read the petition and the comments in it on regulations.gov under the docket number.

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2. What a Qualified Health Claim Is

The constituent update explains the terms. “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.” Because the evidence falls short of that standard, a qualified claim carries wording that tells the reader how strong (or weak) the evidence is.

Enforcement discretion means the agency is saying it does not intend to take action against labels that use the claim in the stated way, rather than writing the claim into a regulation. The letter puts it this way: a yogurt label bearing the claim must meet all applicable legal requirements “with the exception of the requirement that a health claim meet the significant scientific agreement standard and the requirement that the claim be made in accordance with an authorizing regulation.”

The letter also defines the two halves of the claim. It concludes that yogurt is a food and meets the definition of a “substance” under the health-claim regulation (21 CFR 101.14(a)(2)), and that type 2 diabetes meets the regulation’s definition of a disease because, in people with it, “the glucose metabolism systems of the body have been damaged such that the body is not functioning properly.” Under its safety review, the agency agreed that the petition showed “to FDA’s satisfaction that yogurt is safe and lawful” at the levels needed to justify the claim.

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3. The Petition and the Public Comments

The petition was submitted on behalf of a yogurt manufacturer. It proposed two versions of the claim:

• “Eating yogurt regularly may reduce the risk of type 2 diabetes. FDA has concluded there is limited information supporting this claim.”
• “Eating yogurt regularly may reduce the risk of type 2 diabetes according to limited scientific evidence.”

It also proposed the phrases “about three to four servings per week” and “at least three servings per week” as optional insertions after the word “regularly,” and noted that the “evidence supports the health effects of yogurt as a food rather than related to any single nutrient or compound and thus independent of fat or sugar content.”

According to the letter, the FDA filed the petition for comprehensive review on 12 April 2019 and posted it on regulations.gov with a 60-day comment period. The agency received seven comments:

• Four generally supported the claim, pointing to prospective cohort studies that reported protective associations, and to yogurt as a source of protein, calcium, potassium, riboflavin, vitamin B12 and phosphorus.
• One opposing comment noted that the petition cited only prospective cohort studies and no randomized controlled trials, although trials using surrogate markers such as fasting blood glucose, glucose tolerance and insulin resistance would be feasible.
• A second opposing comment argued that total dietary pattern, not a single food or nutrient, drives risk reduction.
• A third opposing comment argued that the claim could increase type 2 diabetes by encouraging people to eat more yogurts, including those high in added sugars; it noted that one in three U.S. adults has prediabetes.

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4. Which Yogurts the Claim Covers

A standard of identity is a federal definition of what a food must contain to be sold under a given name. The petition asked that the claim apply to all types of yogurt meeting the FDA’s standards of identity, then listed in three sections of the Code of Federal Regulations: yogurt (21 CFR 131.200), low-fat yogurt (131.203) and nonfat yogurt (131.206).

The letter notes that FDA issued a final rule modernizing the yogurt standard of identity, with which manufacturers must comply for products labeled on or after 1 January 2024, and that this rule revoked the separate low-fat and nonfat standards. Low-fat and nonfat yogurts are now covered by 21 CFR 130.10, which governs foods that deviate from a standard of identity because they carry a nutrient content claim. The FDA therefore read the petition as covering all products meeting the yogurt standard at 21 CFR 131.200 plus products deviating from it under 21 CFR 130.10, and said this “has no other bearing on the contents of your petition.”

The constituent update records the petition’s point that the association was with yogurt “as a food, rather than any single nutrient or compound in yogurt, regardless of fat or sugar content,” and the letter reaches the same conclusion from the studies it reviewed. That is the FDA’s description of the evidence; it is not a statement that sweetened and unsweetened yogurts are the same in other respects (see section 9 for what the letter says about added sugars).

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5. How the FDA Screened the Evidence

The letter states that the petition cited 117 publications, including 50 observational studies, 33 human intervention studies, 11 reviews and eight meta-analyses. The FDA’s own literature search added 14 observational studies, five meta-analyses, two reviews and one intervention study, most of them published after the petition was filed.

The agency explains that it does not draw conclusions from reviews, meta-analyses or government reports on their own, because they do not give enough detail about each underlying study (who was enrolled, what kind of yogurt was eaten, how intake was measured, whether confounders were adjusted for). It used them as background and to find more individual studies. Animal and laboratory studies were used only as background on possible mechanisms.

Intervention studies: the petition identified 20 controlled intervention studies on surrogate markers of type 2 diabetes. In these, conventional yogurt was compared with a modified yogurt (for example one supplemented with brewer’s yeast, vitamin D or probiotic bacteria) but not with a non-yogurt placebo, so “the petition concludes, and FDA agrees,” that the effect of conventional yogurt could not be assessed from them. No conclusions were drawn from any of the 20.

Observational studies: of 46 reviewed, the FDA could draw no conclusions from 18. The letter gives these reasons:

• eight did not exclude people who already had type 2 diabetes at the start. Because “there is no clear mechanism(s) by which yogurt may affect glucose and/or insulin metabolism,” the agency said it could not tell whether results in people with diabetes apply to risk reduction in people without it;
• four did not adjust for relevant confounders such as physical activity;
• one did not capture soft-drink intake in its food questionnaire, leaving sugar-sweetened beverages unaccounted for;
• two combined yogurt with other foods, and three studied swapping one dairy product for another, so neither group measured yogurt’s own effect.

That left 28 observational studies from which conclusions could be drawn. Nearly all estimated yogurt intake with food-frequency questionnaires, which ask how often people ate listed foods; the letter notes these questionnaires did not separate yogurts by added-sugar content.

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6. What the Remaining Studies Found

The FDA rated nine of the 28 publications as high methodological quality. Three of them reported on four large U.S. prospective cohorts (the Health Professionals Follow-up Study, the Nurses’ Health Study, the Nurses’ Health Study II and the Women’s Health Study), with 40,000 to 85,000 participants each and 10 to 30 years of follow-up. Three more analyzed one Spanish cohort (PREDIMED) of 1,800 to 3,500 people followed for 3.2 to 4.3 years.

• Two of the large U.S. cohorts (HPFS and NHS II) did not show a statistically significant association between yogurt intake and lower type 2 diabetes risk; among women in NHS and WHS, and in the Spanish cohort, the association was statistically significant.
• The intakes that reached significance were 2 or more servings per week in the U.S. cohorts, and 120 g per day of low-fat, 45 g per day of high-fat and 128 g per day of total yogurt in the Spanish cohort, where all fat levels showed the association.
• Findings on changes in yogurt intake were inconsistent: in the three U.S. health-professional cohorts, only NHS showed a significant association; a U.K. cohort found none with HbA1c; a small Iranian cohort found one for low-fat but not high-fat yogurt.

The other 19 publications were rated moderate quality. The letter describes the four cross-sectional studies among them as “highly inconsistent.” Of ten studies on diabetes incidence, only four showed a significant association, with no consistency by sex, sample size or amount eaten. Six studies of surrogate markers (prediabetes, HbA1c, high fasting blood glucose) found no significant association.

The agency’s summary: the evidence “is based exclusively on observational studies which, despite controlling for relevant covariates, cannot exclude residual confounding due to unknown or unmeasured confounders,” such studies “measure associations instead of a cause-and-effect relationship,” and “the study findings were inconsistent.” Most significant associations came from the high-quality studies, while most moderate-quality studies found none. Hence its conclusion: “some credible evidence for a relationship between yogurt intake and reduced risk of type 2 diabetes, but this evidence is limited.”

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7. Where “2 Cups (3 Servings) per Week” Comes From

Health-claim rules require a claim to state the daily dietary intake needed for the claimed effect when no “high” level has been defined (21 CFR 101.14(d)(2)(vii)). The FDA based the minimum on the high-quality studies that showed an association. In two U.S. cohorts (NHS and WHS), 2 servings of yogurt per week had a statistically significant association with reduced risk, and in the questionnaires those studies used, one serving equalled one cup. The agency translated this into 2 cups per week “for a practical measure and consumer understanding.”

On food labels, however, the reference amount customarily consumed (RACC) for yogurt is 2/3 cup, so 2 cups equals 3 label servings. The petition had proposed “about three to four servings per week” and “at least three servings per week” as optional wording; the FDA instead made the phrase “at least 2 cups (3 servings) per week” a required part of the claim. The letter explains that limiting the claim to amounts observed in some well-conducted studies is meant to ensure people “do not consume so little of the substance that it would be very unlikely to provide any health benefit.”

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8. The Wording the FDA Will Not Object To

The FDA intends to consider exercising enforcement discretion for these two claims, and both appear in the constituent update and the letter:

• “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.”

The letter says the qualifying language “will inform consumers about the level of science supporting the claim and prevent them from being misled about the strength of the supporting evidence,” and that describing the evidence as “limited” is truthful and not misleading because “while there is some credible evidence for the claimed relationship, this evidence is limited.”

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9. Label Conditions: Fat, Sodium, Added Sugars and Nutrient Minimums

Disqualifying nutrient levels. General health-claim rules bar a claim on a food that exceeds set levels of total fat (13 g), saturated fat (4 g), cholesterol (60 mg) or sodium (480 mg) per reference amount and per labeled serving, unless the FDA finds otherwise. The letter states the agency intends to consider enforcement discretion only for yogurts that do not exceed those levels, concluding that a claim on yogurts above them “would not assist consumers in maintaining healthy dietary practices.” It expects most yogurts to fall below them; in the FoodData Central data it looked at, the highest-fat yogurt had 8 g of fat per serving. It notes that a yogurt could feasibly be made to exceed the sodium level, giving salted caramel yogurt as an example, and that the Dietary Guidelines for Americans, 2020–2025, recommend that most dairy choices be fat-free or low-fat.

Added sugars. The FDA has not set a disqualifying level for added sugars, and because the evidence linked yogurt to lower risk irrespective of fat or sugar content, the letter says added-sugar level “is not an enforcement discretion factor” for this claim “at this time.” It adds that the agency is “concerned that the use of a qualified health claim on yogurts that contain a significant amount of added sugars could contribute empty calories to the diet.” It cites the Dietary Guidelines’ recommendation to keep added sugars below 10 percent of calories and their note that added sugars average almost 270 calories, or more than 13 percent of calories, per day in the U.S. population. Addressed to manufacturers, the letter states that the FDA “encourages careful consideration of whether to use the claim on products that could contribute significant amounts of added sugars to the diet.”

Minimum nutrient content. A conventional food may carry a health claim only if it naturally provides at least 10 percent of the Daily Value of certain nutrients per reference amount. The letter expects all yogurts to contain more than 5 g of protein per reference amount (10 percent of the 50 g reference), and says the agency will also consider enforcement discretion where a yogurt provides 10 percent or more of the Daily Value for vitamin D or potassium, nutrients added to the mandatory Nutrition Facts declaration by a 2016 rule.

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10. What the Decision Does Not Do

• It is not an authorized health claim. The evidence did not meet the “significant scientific agreement” standard, and the claim is allowed only through enforcement discretion, not by regulation.
• It is not an FDA finding that yogurt prevents type 2 diabetes. The agency’s own words are that the evidence is “limited,” drawn only from observational studies that measure associations rather than cause and effect, and every permitted claim must say the evidence is limited.
• It does not require any yogurt label to carry the claim; it describes when the FDA does not intend to object if a label does.
• It does not cover yogurts above the disqualifying fat, saturated fat, cholesterol or sodium levels, or wording that drops the “at least 2 cups (3 servings) per week” phrase or the statement about limited evidence.
• It is not fixed for good. The letter says that if new information is submitted, the FDA intends to evaluate whether it “necessitates a change in this decision,” whether toward significant scientific agreement, toward no longer supporting the claim, or because of safety concerns.

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11. Dates and Legal Status as of October 11, 2026

• 12 April 2019: petition filed for comprehensive review in docket FDA-2019-P-1594, with a 60-day comment period.
• 1 January 2024: compliance date of the modernized yogurt standard of identity referred to in the letter.
• 1 March 2024: letter of enforcement discretion signed and constituent update published.

Status: in effect as an enforcement-discretion decision. A query of Federal Register documents from 2024 through 11 October 2026 found no document on this claim, and enforcement-discretion letters are not written into the Code of Federal Regulations. Nothing found in that period withdraws or changes the decision.

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12. How the Decision Fits Other FDA Labeling Actions

The letter places the decision within the FDA’s existing health-claim process. It says the petition was submitted under the agency’s 2003 guidance “Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements” and reviewed under its 2009 guidance “Evidence-Based Review System for the Scientific Evaluation of Health Claims.” The FDA lists the qualified health claims it has responded to on its Qualified Health Claims page (see Primary Documents).

The letter also ties the decision to two other labeling rules: the yogurt standard-of-identity rule whose compliance date was 1 January 2024 for products labeled on or after it, and the May 2016 rule revising the Nutrition Facts label (81 Fed. Reg. 33742), which, the letter notes, requires added sugars to be declared in grams and as a percent Daily Value so that consumers can see the amount of added sugars in a food.

Later in 2024 the FDA issued its final rule on when foods may use the nutrient content claim “healthy”; that separate, voluntary labeling action is reported on the “Healthy” claim final rule page.

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13. Primary Documents

1. U.S. Food and Drug Administration, Human Foods Program (2024). FDA Announces Qualified Health Claim for Yogurt and Reduced Risk of Type 2 Diabetes. Constituent Update, 1 March 2024 — fda.gov constituent update
2. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Nutrition and Food Labeling (2024). Petition for a Qualified Health Claim for Yogurt and Reduced Risk of Type 2 Diabetes Mellitus (Docket No. FDA-2019-P-1594). Letter of enforcement discretion, 1 March 2024, 36 pages — FDA response letter (PDF)
3. Public docket FDA-2019-P-1594, the qualified health claim petition — regulations.gov FDA-2019-P-1594-0001
4. U.S. Food and Drug Administration. Qualified Health Claims (program page listing the agency’s qualified health claim decisions) — fda.gov Qualified Health Claims

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Key Research Papers

1. Choi HK, Willett WC, Stampfer MJ, Rimm E, Hu FB (2005). Dairy consumption and risk of type 2 diabetes mellitus in men: a prospective study. Archives of Internal Medicine 165(9):997-1003 — PubMed PMID: 15883237
2. Liu S, Choi HK, Ford E, Song Y, Klevak A, Buring JE, Manson JE (2006). A prospective study of dairy intake and the risk of type 2 diabetes in women. Diabetes Care 29(7):1579-1584 — PubMed PMID: 16801582
3. Chen M, Sun Q, Giovannucci E, Mozaffarian D, Manson JE, Willett WC, Hu FB (2014). Dairy consumption and risk of type 2 diabetes: 3 cohorts of US adults and an updated meta-analysis. BMC Medicine 12:215 — PubMed PMID: 25420418
4. Babio N, Becerra-Tomás N, Martínez-González MÁ, et al. (2015). Consumption of yogurt, low-fat milk, and other low-fat dairy products is associated with lower risk of metabolic syndrome incidence in an elderly Mediterranean population. Journal of Nutrition 145(10):2308-2316 — PubMed PMID: 26290009
5. Díaz-López A, Bulló M, Martínez-González MA, et al. (2016). Dairy product consumption and risk of type 2 diabetes in an elderly Spanish Mediterranean population at high cardiovascular risk. European Journal of Nutrition 55(1):349-360 — PubMed PMID: 25663611
6. Drouin-Chartier JP, Li Y, Ardisson Korat AV, Ding M, Lamarche B, Manson JE, Rimm EB, Willett WC, Hu FB (2019). Changes in dairy product consumption and risk of type 2 diabetes: results from 3 large prospective cohorts of US men and women. American Journal of Clinical Nutrition 110(5):1201-1212 — PubMed PMID: 31504094
7. Trichia E, Luben R, Khaw KT, Wareham NJ, Imamura F, Forouhi NG (2020). The associations of longitudinal changes in consumption of total and types of dairy products and markers of metabolic risk and adiposity: findings from the European Investigation into Cancer and Nutrition (EPIC)-Norfolk study, United Kingdom. American Journal of Clinical Nutrition 111(5):1018-1026 — PubMed PMID: 31915813

All seven papers are among the studies the FDA’s letter names in its review of the evidence.

PubMed Topic Searches

1. PubMed: yogurt and type 2 diabetes, prospective cohorts
2. PubMed: yogurt, insulin resistance and randomized trials
3. PubMed: fermented dairy and type 2 diabetes meta-analyses

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Connections

• FDA Actions of 2024
• FDA and Regulation
• Yogurt
• Yogurt Benefits
• Type 2 Diabetes
• Prediabetes
• Hemoglobin A1C
• Fermented Foods
• FDA Final Rule on the “Healthy” Claim (2024)
• Over-the-Counter Glucose Monitor (2024)

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