Tuesday, October 04, 2016

FDA to Revise the Nutrient Content Claim “Healthy”

The Food and Drug Administration (FDA) announced the start of a public process to redefine the “healthy” nutrient content claim for food labeling.

Under the food labeling rules, “healthy” and similar terms are generally an implied nutrient content claim. 21 C.F.R. § 101.65(d). A food must meet certain requirements to be eligible for the “healthy” claim.

FDA acknowledges that the 1993 regulation for “healthy” as a nutrient content claim is in need of an update. The latest nutrition science and the current dietary recommendations, among other things, has shifted from recommending diets low in total fat to now draw distinctions among the types of fat (unsaturated fats vs. saturated fats and trans fat) in the diet.

While FDA is receiving comments and reconsidering the regulation defining “healthy,” FDA states, “Because the rulemaking process can sometimes be lengthy, we intend to exercise enforcement discretion in the interim with respect to some of the existing criteria for the nutrient content claim “healthy” if the alternative nutrient criteria described below are met.”

FDA Guidance: Use of the Term “Healthy” on Food Labels and FDA’s Enforcement Discretion

Specifically, FDA’s Guidance announces that it intends to exercise enforcement discretion for products labeled as “healthy” that are not low in total fat, 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 definition for “healthy” also includes a nutrient contribution criterion. Healthy dietary patterns not only restrict nutrients that increase risk of chronic disease, but also help assure nutrient adequacy to ensure sufficient intake of nutrients that are important in sustaining body function and reducing the risk of disease. The current definition of “healthy” focuses on foods providing a good or excellent source of nutrients for which there had been public health concern in 1993: vitamin A, vitamin C, 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. FDA now recognizes vitamin D and potassium as nutrients that should be encouraged in the diet, in addition to iron, calcium, and fiber.

Therefore, FDA intends to exercise enforcement discretion when the food contains less than ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of vitamin A, vitamin C, calcium, iron, protein, and fiber, but the food contains at least 10% of the DV per RACC of vitamin D or potassium.

FDA has requested information and comments docket number FDA–2016-D–2335  FDA also asks for input on issues related to the “healthy” claim, including:
  • Is the term “healthy” most appropriately categorized as a claim based only on nutrient content?
  • What types of food, if any, should be allowed to bear the term ‘‘healthy?”
  • What nutrient criteria should be considered for the definition of the term “healthy?”
  • What are the public health benefits, if any, of defining the term “healthy” or other similar terms in food labeling?
  • What is consumers’ understanding of the meaning of the term “healthy” as it relates to food?
Information and comments must be submitted to FDA by Jan. 26, 2017.

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