FDA Releases Interim Guidance on “Healthy” Labeling

New interim guidance from the Food and Drug Administration eased the restrictions on foods that can be labeled as “healthy,” and provides insight as to how the agency approaches fats and certain nutrients in light of recent scientific developments and changing nutritional recommendations.

Previously, FDA regulations established certain conditions for bearing a “healthy” label (or related terms such as “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”), with specific criteria as to which nutrients should be limited in the diet, such as total fat and saturated fat, and which nutrients should be encouraged, including vitamins A and C.

The Dietary Guidelines have changed, however, and specific recommendations have “evolved over time as nutrition science has advanced,” the agency explained. “For example, scientific understanding and nutrition guidance has shifted from recommending diets low in total fat (2005 Dietary Guidelines) to no longer recommending limiting overall fat intake, and instead prioritizing increasing intakes of polysaturated and monounsaturated fats and decreasing intakes of saturated fat and trans fat (2015-2020 Dietary Guidelines).”

In light of the changes—and the argument raised in a petition filed by the manufacturer of KIND snack bars—the FDA tweaked its guidance for the industry.

First, with regard to fat, foods “that use the term ‘healthy’ on their labels that are not low in total fat should have a fat profile makeup of predominantly mono and polyunsaturated fats,” the agency said, a conclusion in line with the most recent dietary fat recommendations that have shifted away from limiting total fat intake. So a food may label itself as “healthy,” provided that “(1) the amounts of mono and polyunsaturated fats are declared on the label and (2) the amounts declared constitute the majority of the fat content,” the FDA said.

The second shift occurred in beneficial nutrients. Historically, the definition of “healthy” focused on the presence of vitamins A and C, as well as iron, calcium and dietary fiber. “Nutrient intakes have shifted over time, however, and vitamins A and C are no longer nutrients of public health concern,” the FDA said. “The nutrients of public health concern now include potassium and vitamin D, in addition to iron and calcium.”

In recognition of this change, a food may be labeled “healthy” if it contains at least ten percent of the daily value of potassium or vitamin D that a consumer customarily consumes, the interim guidance explained.

The agency also requested comment on the updated labeling guidance, including feedback on issues such as “Is the term ‘healthy’ most appropriately categorized as a claim based only on nutrient content?” and “What types of food, if any, should be allowed to bear the term ‘healthy’?” The FDA also asked “Should all food categories be subject to the same criteria?” and whether consumers understand the term “healthy,” as it relates to food and their expectations of foods that carry a “healthy” claim.

To read the FDA’s guidance for industry, click here.

To read the request for comments and information, click here.

Why it matters: Until the FDA finalizes its position on “healthy” labeling, the agency said it would “exercise enforcement discretion” for claims if the alternative nutrient criteria set forth in the interim guidance are met. Comments on the use of the term “healthy” in the labeling of food products will be accepted until January 26, 2017.



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