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    U.S. FDA proposes 'healthy' rule

    IDFA states FDA must clearly establish criteria for dairy products.

    IDFA logo.jpg
    September 28, 2022

    The U.S. Food and Drug Administration (FDA) is proposing to update the definition for the implied nutrient content claim “healthy” to be consistent with current nutrition science and Federal dietary guidance, especially the Dietary Guidelines for Americans (Dietary Guidelines), regarding how consumers can maintain healthy dietary practices.

    This action, if finalized, will revise the requirements for when the term “healthy” can be used as an implied claim in the labeling of human food products to indicate that a food’s level of nutrients may help consumers maintain healthy dietary practices by helping them achieve a total diet that conforms to dietary recommendations.

    Joseph Scimeca, PhD, senior vice president of regulatory and scientific affairs for the International Dairy Foods Association (IDFA), released the following statement today on this proposed rule.

    “Today, according to the federal 2020-2025 Dietary Guidelines for Americans (DGAs), more than 90% of Americans do not consume enough dairy to meet daily nutritional requirements. Therefore, IDFA believes it is essential that the voluntary, proposed rule released today by the FDA must clearly establish criteria for dairy products that encourage the consumption of dairy foods while also helping consumers select the options that meet their health, taste, and lifestyle needs. While the proposed rule takes some positive steps toward encouraging consumption of dairy products to help Americans meet the recommendations of the 2020-2025 DGAs, it falls short in many other important areas by limiting how dairy labels communicate the full nutritional benefits of dairy to consumers. 

     “More than five years ago, IDFA encouraged FDA to set criteria for a ‘healthy’ claim specifically for the dairy food category that took into consideration the full nutrient profile and dietary contributions of dairy. At the time, and still valid today, our argument was simple: The current regulatory definition for a ‘healthy’ claim does not consider the unique nutrient contributions of dairy products but does set different nutrient levels for fruits and vegetables, meat products, seafood, and cereal grain products.

    The proposed rule released \does include dairy as a recommended food group consistent with the DGAs and sets criteria that a ‘healthy’ claim on dairy must also meet limits for saturated fats, sodium, and added sugars. In fact, the proposed rule sets criteria to require a product to contain the equivalent of at least a ¾ cup serving of dairy product to bear a ‘healthy’ claim, a positive step toward encouraging consumption of dairy. However, the rule ignores overwhelming nutrition and dietary science demonstrating that dairy is a crucial part of a healthy diet beginning at a very young age. In fact, no other type of food or beverage provides the unique combination of 13 essential nutrients that milk and dairy contribute to the American diet, including high quality protein, calcium, vitamin D, and potassium, along with the health benefits including better bone health and lower risk for type 2 diabetes and cardiovascular disease. Furthermore, the proposed rule ignores a fundamental tenant of nutrition guidance:  A food must be consumed in order for it to have any nutritional and health benefit. Restricting or limiting dairy foods—which are severely under consumed according to the federal government’s own DGAs and widely known to be nutritionally dense—flies in the face of science."

     Specifically, the proposed rule includes the following criteria for dairy products making ‘healthy’ claims:

     

    • Total Fat: IDFA encouraged no limit on total fat. The proposed rule sets no limit on total fats, aligning with IDFA’s view.
    • Milk Fat: IDFA encouraged no limit on saturated fat when the source of saturated fat is milk fat. As the proposed rule notes, ‘Current nutrition science supports a view that the type of fat is more relevant than overall total fat intake in risk of chronic diseases.’ The proposed rule sets a requirement for dairy products to contain no more than 10% Daily Value (DV) of saturated fat per Reference Amount Customarily Consumed (RACC). This level should permit all low-fat and fat-free dairy products to qualify for the claim, as recommended by IDFA; however, the proposed rule would prohibit many nutritious dairy products from carrying a ‘healthy’ claim, which runs counter to a significant body of nutrition science. IDFA encourages the FDA to revisit this portion of the rule to recognize the benefits of dairy at each fat level. Ignoring the benefits of milk fat will be a lost opportunity to embrace newer science and will contribute to ongoing confusion about the healthfulness of all dairy products.
    • Added Sugars: IDFA believes that flavored milk should be less than 13 grams of added sugar per 8 fluid ounce serving, and flavored yogurt should be less than 23 grams of total sugar per 6 ounce serving. The proposed rule sets a limit of 5% DV of added sugar per RACC, which would be the equivalent of 2.5 grams of added sugar per serving. Here, the proposed rule would prohibit a number of nutrient dense dairy products. Moderate levels of added sugars in dairy products increase palatability, thereby encouraging Americans to consume these nutrient-dense foods. IDFA encourages the FDA to revisit this portion of the rule to recognize the benefits of moderate levels of added sugar to increase consumption of nutrient dense, healthy foods, including dairy. 
    • Sodium: The proposed rule did acknowledge the important functional and food safety uses of salt in cheese but kept the sodium limit for dairy at 10% DV, similar to other food categories. In keeping with IDFA’s past comments on sodium in foods, IDFA believes a ‘healthy’ claim should reflect an understanding that salt plays a crucial role in the manufacture and ripening of natural and processed cheeses and impacts overall product functionality, integrity, safety, and quality. IDFA encourages the FDA to revisit this portion of the rule to recognize that cheese is the second highest source of calcium yet contributes less than four percent of the sodium to the diet. 
    • Calcium, Protein, Vitamin A: The proposed rule did not include any nutrients that must be present in a food to qualify for a ‘healthy’ claim. FDA explained that positive nutrient contributions of foods and beverages would be included by requiring a product to meet certain amounts of food groups recommended under the DGAs. IDFA believes a dairy food offering a good source of calcium, protein, and/or vitamin A, could bear the ‘healthy’ claim.
    • Truthful and Not Misleading: IDFA believes that use of the term healthy should be permitted, independent of the defined claim, as long as its use is truthful and not misleading and is in line with current dietary guidance, such as that found in the DGAs. The proposed rule agrees and clarifies that the criteria for the healthy claim would only apply when the word healthy is used as part of a nutritional context.”

    KEYWORDS: FDA Healthy IDFA

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