The U.S. Food and Drug Administration recently published a proposed rule that, if implemented, would update the labeling standards that food products must meet in order to be labeled as “healthy.” The FDA first established a definition for “healthy” in 1994, and at that time nutrition science and federal dietary guidance focused more on the individual nutrients contained in food. According to the FDA, the proposed rule would “align the definition of ‘healthy’ with current nutrition science, the updated Nutrition Facts label and the current Dietary Guidelines for Americans,” with the goal of assisting consumers to increase their consumption of under-consumed dietary components.
The proposed rule would achieve this goal by requiring “healthy” foods to contain a minimum quantity of at least one of the specified food groups or subgroups recommended by the Dietary Guidelines such as fruits and vegetables, while limiting over-consumed ingredients that may lead to negative health consequences such as sodium or added sugars. The FDA’s proposed framework for the updated definition of “healthy” focuses on ensuring that foods labeled as healthy can qualify to bear the title by helping consumers to build a diet consistent with current dietary recommendations.
The existing definition has limits for total fat, saturated fat, cholesterol and sodium and to qualify, foods must also provide at least 10% of the Daily Value (DV) for one or more of the following nutrients: vitamin A, vitamin C, calcium, iron, protein and fiber. Under the proposed guidelines, different food groups have their own specific nutrient criteria based on the most contemporary nutritional science. For example, a cereal would need to contain ¾ ounces of whole grains and contain no more than 1 gram of saturated fat, 230 milligrams of sodium and 2.5 grams of added sugars to be eligible to be called “healthy.” Additionally, there are proposed limits on three specific nutrients: sodium, saturated fat and added sugar. The threshold for the limits is based on a percentage of the Daily Value for the nutrient and varies depending on the food and food group. The limit for sodium is 10% of the Daily Value per serving (i.e., 230 milligrams per serving).
Under the proposed definition, raw whole fruits and vegetables would automatically qualify for the “healthy” claim because of their nutrient profile and the fact that they contribute to an overall healthy diet. If implemented, certain foods currently labeled as healthy would no longer be eligible, while other currently ineligible foods would become eligible under the new guidelines. Foods currently ineligible to bear the “healthy” label under the existing regulatory definition that would qualify under the proposed definition include water, avocados, nuts and seeds, higher fat fish, such as salmon, and certain oils. Food products that currently may be labeled “healthy” that would not under the proposed definition include white bread, highly sweetened yogurt and highly sweetened cereal.
On a separate but related track, the FDA is also researching a symbol that manufacturers could use on the front of the pack to show that their product meets the definition of the “healthy” claim. Having a standardized graphic to show that a food qualifies for the “healthy” claim would further support the FDA’s goal of helping consumers more easily identify packaged food products that help them build healthy eating patterns.
If the new rule is implemented, food manufacturers who use the term “healthy” in their labeling must review those labels to ensure the term may still be used. Class-action lawsuits litigating whether certain foods are eligible to use the term are likely. However, if recent labeling class actions have revealed anything it is that FDA compliance does not automatically shield a food manufacturer from lawsuits alleging that its advertising or labeling is false or misleading.
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