WASHINGTON, May 3, 2017 - The Food and Drug Administration will have to sift through hundreds of comments containing often-conflicting advice as it tries to redefine the term “healthy” for use on food products.

FDA accepted comments until April 26 and now has the unenviable task of trying to figure out how to balance the recommendations of the 2015-2020 Dietary Guidelines for Americans (DGA), which emphasizes the importance of dietary patterns as a whole, with Americans’ need for specific nutrients.

At least one group said FDA needs to go back to the drawing board. The Academy of Nutrition and Dietetics, the largest association of food and nutrition professionals in the U.S, said the science behind the DGA needs to be improved.

“The academy remains concerned about the present state of scientific analysis…, specifically the inability of (USDA’s) Nutrition Evidence Library (NEL) to support inferences about the contributions that individual food groups make to the overall effect observed for a dietary pattern,” the academy said in its comments. The NEL supported development of the DGA by conducting systematic reviews on diet and health.

But NEL’s reviews for specific food groups relied on insufficient evidence and produced inconsistent results, the academy said. For example, in the cardiovascular disease review, dairy “was reported both negatively and positively in different studies,” the academy said, quoting the NEL review. “One study reported an unfavorable association between total dairy and (coronary heart disease) risk; however, two studies reported a favorable association between total dairy and (hypertension).”

“We strongly encourage the FDA to review the present status of the research to ascertain whether the gaps in the NEL’s scientific process have been remedied,” the academy said, recommending that FDA postpone the “healthy” rulemaking “unless and until the inferences underlying many of the proposed regulatory schemes suggested by various commenters are supported by rigorous scientific substantiation.”

The academy also said FDA needs to conduct more consumer research. “Although ‘healthy’ is seemingly well-understood, it has an amorphous ‘we know it when we see it’ essence to it,” the group said in its comments. “Not only does ‘healthy’ lack a specific, common definition, but the definitions are not universal or objective.”

The academy said its members are concerned that labeling individual food products as “healthy” may, in fact, “make it less likely that consumers understand that the DGA recommends that a healthy eating pattern includes vegetables, fruits, whole grains (while limiting, not eliminating, refined grains), fat-free and low-fat dairy products and nutrient-dense protein sources, because it is unlikely that a packaged meal would include all of these groups in portion-sizes recognized as servings.”

The issue of “added sugars” received a lot of attention in the comments. The Center for Science in the Public Interest, for example, said “healthy” foods should not be allowed to contain more than 3 grams of added sugars, or about 5 percent of the Daily Value. CSPI cited a wide range of bad health outcomes associated with overconsumption of added sugars, including “excess body weight in children and adults and an increased risk of type 2 diabetes in adults that is not fully explained by body weight.”

Ocean Spray, however, said that if FDA addresses added sugars, it should “create an exemption where nutrient-dense naturally tart fruits are concerned.”

“An accommodation allowing cranberry products with appropriate levels of added sugars to fit within the ‘healthy’ definition is essential to letting consumers understand that these products fit within the positive eating patterns endorsed under the Dietary Guidelines,” the grower-owned cooperative said in its comments. It cited the DGA’s statement that “there is room for Americans to include limited amounts of added sugars in their eating patterns to improve the palatability of some nutrient-dense foods, such as fruits and vegetables that are naturally tart (e.g. cranberries).”

CSPI also said that the “healthy” definition “should encourage the healthiest form of fruit – whole fruit – and exclude fruit juice.”

“A ‘healthy’ claim on juice, even 100 percent fruit juice, would likely promote excess consumption of calories from fruit juice, which may lead to weight gain among both children and adults,” the group said.

The Juice Products Association disagreed, saying that 100 percent fruit and vegetable juices and 100 percent juice blends “be subject to the same criteria for ‘healthy’ that apply to raw fruits and vegetables and single-ingredient or mixtures of frozen or canned fruits and vegetables.” The 100 percent juices and blends “contribute a variety of required nutrients to the diet and support healthy dietary practices.”

Among other comments:

The North American Meat Institute said processed foods should eligible for a “healthy” label. “Processing allows perishable products to last longer through freezing, canning, and other preservation methods. Such production practices allow for maximum utilization of crop yields and minimize the potential for food waste. Processing also allows fortification of nutrients that may not be consumed naturally.”

The International Dairy Foods Association urged FDA to establish criteria for a “healthy” claim “specifically for the dairy food category, taking into consideration the full nutrient profile and dietary contributions of dairy.” IDFA also called for no limit on total fat and no limit on saturated fat when the source of saturated fat is milkfat. “If milkfat is not exempted from saturated fat limits, all lowfat and fat free dairy products should be included in ‘healthy’ claim,” IDFA said.

KIND LLC, which jump-started the process of redefining “healthy” when it petitioned FDA in December 2015, said that food products with a “healthy” nutrient content claim “should contain a meaningful amount of foods that are part of a healthy dietary pattern and identify the source and quantity of the ingredient(s) supporting the meaningful amount requirement” and that there should be no threshold for “good” nutrients. Second, the “healthy” definition should not include thresholds for “good” nutrients such as vitamins A, C and D, calcium, iron, potassium, protein, and fiber.

The Grocery Manufacturers Association proposed that “the current list of nutrients included in the interim definition of ‘healthy’ — protein, fiber, calcium, iron and vitamins A & C – be expanded to include choline, magnesium and vitamin E, (which) were all identified as underconsumed nutrients in the 2015-2020 DGA.” GMA also supported retaining current provisions that allow fortification to meet the 10 percent requirement for nutrients.

The American Beverage Association said that “unsweetened, zero-calorie beverages should automatically qualify to bear a ‘healthy’ label. Such beverages could include unflavored and flavored non-carbonated (still) and carbonated (sparkling) waters; unsweetened, zero-calorie teas; or unsweetened, zero-calorie coffees.”