Ask consumers what makes a food product “healthy” and you will receive a variety of responses. According to IFIC’s 2016 Food and Health Survey, one-third of Americans believe healthy is defined by the absence (or low levels) of particular nutrients, two in 10 believe healthy choices contain certain foods/components, while 17 percent believe these foods are minimally processed and contain simple ingredients. The FDA, however, has the final say about what this term means when used on food labels. Since the introduction of the “healthy” claim roughly 20 years ago, FDA regulations have stated food labels using this term must meet standards for nutrients to limit, including total fat, saturated fat, cholesterol and sodium, and nutrients to encourage, such as vitamins A and C, calcium, iron and fiber (the specific criteria for these nutrients vary based on the food category).
On September 28, 2016, FDA announced it is taking steps to redefine the “healthy” claim in food labeling. Several factors lead FDA to this decision. According to the agency, recent updates to the Nutrition Fats label, new scientific information, along with recommendations presented in the 2015-2020 Dietary Guidelines prompted FDA to reevaluate the meaning of the term healthy.
FDA is seeking public comments until April 26, 2017 about several issues and questions related to the “healthy” claim. You can find the full list here, but a few examples include:
- What types of food should be allowed to bear the term? Should different food categories be subject to the same requirements?
- What nutrient criteria should be considered (i.e., nutrients to limit, nutrients to encourage)?
- What are consumers’ expectations of foods that carry a “healthy” claim?
- What would be the costs to the industry of the change?
It could take approximately two years for FDA to redefine the “healthy” claim. Because it is a lengthy process, the organization has provided guidance to the industry for use of the term on food labels in the interim. The existing regulatory definition for the term “healthy” remains in effect, however FDA’s guidance states they intend to exercise enforcement discretion in two different situations:
- Fat content. Because dietary fat recommendations have shifted to focus on the type of fat rather than the amount, foods exceeding the existing total fat threshold can bear the “healthy” claim if the amount of monounsaturated and polyunsaturated fat is listed on the nutrition label and the amount of these fats makes up more than half of the total fat content.
- Beneficial Nutrients. Current criteria for the “healthy” claim targets foods providing a good (10 percent of the daily value) or excellent (20 percent of the daily value) source of nutrients that historically have been nutrients of concern: vitamin A, vitamin C, calcium, iron and fiber. However, according to the 2015-2020 Dietary Guidelines nutrients of public concern now include calcium, vitamin D, iron and potassium. To reflect this change, FDA will exercise discretion for any food bearing the “healthy” claim that supplies at least 10 percent of the daily value of either potassium or vitamin D (rather than vitamin A, vitamin C, calcium, iron and fiber), as long as the nutrient(s) is displayed on the Nutrition Facts panel.
Since the guidance was released, several brands have debuted the “healthy” claim on their food packages. But will they be able to continue once the new regulations are announced? Douglas Balentine, Director of FDA’s CFSAN Office of Nutrition & Food Labeling, hinted about what the food industry may be able to expect:
- Place an emphasis on the type of fat rather than the amount, with a focus on using monounsaturated and polyunsaturated fat in place of saturated and trans fat.
- Address added sugar, as mounting evidence links the ingredient to weight gain and heart disease.
- Concentrate on current nutrients of concern, such as potassium and vitamin D.
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