The US Food and Drug Administration (FDA) has opened a public process to redefine the “healthy” nutrient content claim for food labeling. The regulatory criteria for use the claim “healthy” is being re-evaluated in light of the latest nutrition science and the current dietary recommendations.The comment period for the Request for Information and the Guidance for Industry started on September 28, 2016 (more information).As the rulemaking process can be lengthy, food manufacturers can continue to use the term “healthy” on foods that meet the current regulatory definition. In addition, the FDA has published the guidance for industry: Use of the Term “Healthy” in the Labeling of Human Food Products.The purpose of this guidance is to advise manufacturers who wish to use the implied nutrient content claim “healthy” to label their food products. The FDA does not intend to enforce the regulatory requirements for products that use the term if certain criteria described in the guidance document are met.The requirements for foods that use the implied nutrient content claim “healthy” on their labels are as follow:
- Foods that are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats. The focus of the most recent dietary fat recommendations has shifted away from limiting total fat intake to encouraging intakes of mono and polyunsaturated fats.
- Foods that contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D. The nutrients for which there had been public health concern are changing. Vitamins A and C are no longer nutrients of public health concern and potassium and vitamin D, in addition to iron and calcium are now included in this category.
This guidance is immediately effective because the FDA has determined that prior public participation is not feasible or appropriate.More information