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Marketers of yogurt products may celebrate the latest approval by the Food and Drug Administration (“FDA”) of a new qualified health claim related to the consumption of yogurt and type 2 diabetes. However, producers of such products should also be cautious in presenting these claims on product labeling so as not to run afoul of limitations imposed by FDA related to this new qualified health claim.

FDA’s recent announcement through a letter of enforcement discretion stated that FDA will not object to the use of certain qualified health claims involving the consumption of yogurt and reduced risk of type 2 diabetes, provided that the claims are not misleading to consumers and other regulatory requirements are met.

In general, health claims in food labeling are intended to show that a food or food component may reduce the risk of a disease or health-related condition. Health claims must be approved by the FDA and must be supported by significant scientific agreement (“SSA”) among qualified experts that the claim is supported by the “totality of publicly available evidence” for a relationship between the food and disease. Unlike an authorized health claim, qualified health claims do not need to meet the SSA standard of evidence but must be accompanied by a disclaimer that accurately communicates to consumers the level of scientific evidence that supports the claim.   

The recent letter of enforcement discretion was issued in response to a petition requesting that FDA review evidence supporting the use of a qualified health claim regarding the relationship between the consumption of yogurt and a reduced risk of type two diabetes for all types of yogurt meeting FDA’s standards of identity. You can find our prior discussion of FDA’s different standards of identity for yogurt here. Significantly, the petition argues that the evidence supporting these health effects are based on yogurt’s food profile as a whole and are not based on an ingredient or component of yogurt. Thus, these claims should be used for any type of yogurt product regardless of the sugar or fat content.

FDA ultimately agreed with this argument as well as the evidence provided but noted that the available evidence is “limited” and issued additional restrictions to be used when asserting this qualified health claim. First, FDA considers 2 cups or 3 servings of yogurt per week to be the minimum consumption level required for the use of this claim.  Second, the yogurt product may not exceed any of the disqualifying nutrient levels for total fat, saturated fat, cholesterol, or sodium established under 21 C.F.R. § 101.14(a)(4). Notably, FDA has not set a disqualifying nutrient level for added sugars by regulation and therefore the level of added sugars in a yogurt product will not trigger FDA’s enforcement discretion related to this health claim. Finally, any yogurt product bearing the qualified health claim on its product labeling must still meet at least 10 percent of the Daily Value of certain nutrients (such as vitamin A, vitamin C, calcium, and iron) under 21 C.F.R. § 101.14(e)(6).

FDA’s decision authorizes marketers of yogurt products that meet FDA’s standards of identity at 21 C.F.R. § 131.200 to include the following qualified health claims on their product labeling:

  • “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.”

Companies intending to market their products with the qualified health claim should carefully review their product labeling in order to ensure compliance with FDA’s letter of enforcement discretion. Companies should also be mindful of the US Federal Trade Commission’s (“FTC”) Health Products Compliance Guidance when marketing products with health claims as this guidance outlines the requirements for properly disclosing limitations related to health claims.

Contact Us

Husch Blackwell has significant experience advising yogurt and other dairy manufacturers on FDA regulations, including those involving standards of identity and product labeling. Our FDA lawyers have the required scientific and technical backgrounds to assist companies with understanding requirements for product labeling and proposing changes that will be advantageous for their business. Contact Emily Lyons, or your Husch Blackwell attorney for more details.

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Photo of Lauren Petrin Lauren Petrin

Lauren assists food systems and life sciences clients with FDA regulatory compliance.

Lauren entered law school with the intention of working in healthcare; however, her Health Law Certificate courses introduced her to Food & Drug Administration (FDA) regulatory work. Fascinated by the intersection

Lauren assists food systems and life sciences clients with FDA regulatory compliance.

Lauren entered law school with the intention of working in healthcare; however, her Health Law Certificate courses introduced her to Food & Drug Administration (FDA) regulatory work. Fascinated by the intersection of health and consumer protection, she accepted an internship with the FDA’s Office of Legislation, an experience that gave her an inside perspective on the agency’s inner workings and interactions. As an associate at her first law firm, Lauren worked with medical device companies and drug developers, reviewing their claims in light of FDA regulations, negotiating clinical trial agreements, and responding to FDA warning letters and FDA inspections.

In early 2024, Lauren joined Husch Blackwell as a member of the firm’s Food Systems industry group. While she continues to work with clients in the life sciences space, her primary focus is food and agricultural organizations and trade groups, food producers, importers, and other private food companies, whom she advises on compliance with the Federal Food, Drug, and Cosmetic Act (FDCA); Federal Food Safety Modernization Act (FSMA); and other FDA regulations. She assists in the development of corporate compliance strategies, as well as with responses to enforcement actions received from the FDA or U.S. Department of Agriculture (USDA). Lauren enjoys working with such a core component of everyday life and helping companies ensure that their customers are safe.

Known as a detail-oriented, highly responsive professional, Lauren has a reputation for always having solutions ready for clients and attending every meeting with new ideas in hand.

Photo of Emily Lyons Emily Lyons

Emily grew up on a northern Illinois dairy farm, and now helps clients bridge the gap from farm to fork. She guides clients on complex regulatory issues as they bring dairy products, beverages, fruits and vegetables, processed foods and other agricultural goods to…

Emily grew up on a northern Illinois dairy farm, and now helps clients bridge the gap from farm to fork. She guides clients on complex regulatory issues as they bring dairy products, beverages, fruits and vegetables, processed foods and other agricultural goods to market. At the intersection of agriculture, food and environment, Emily handles compliance matters such as labeling, marketing, permitting and agency inquiries including the Food Safety Modernization Act, Pasteurized Milk Ordinance, USDA National Organic Program and bioengineered food disclosure standard, Generally Recognized as Safe status for food additives and food contact substances, and the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).