FDA hinted in May that it was planning to reconsider its longstanding and controversial criteria for using the term “healthy.”  Today, it announced the beginning of the formal process to make changes to the definition of the term.  The agency opened a new docket and is publishing a Request for Information and Comments relating to use of the term “healthy” in the labeling of human food products.  It also issued a guidance document stating that 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.

Under current regulations, “healthy” can only be used as an implied a nutrient content claim when a food product meets certain nutritional criteria. For instance, most individual food products marketed as “healthy” must be low in fat and saturated fat, must have no more than 480 mg of sodium or the disclosure level for cholesterol, and must contain at least 10 percent Daily Value of one of the following nutrients:  vitamin A, vitamin C, calcium, iron, protein, or fiber.

Companies and experts have noted that this conception of “healthy” is inconsistent with current nutritional guidance, including the 2015-2020 Dietary Guidelines for Americans.  Stakeholders have also asked for clarification on claims that a product can be a part of a healthy diet or is useful in maintaining healthy dietary practices.  In particular, a citizen petition from KIND LLC argues that the current FDA policy “limits the ability of food producers to tell consumers that products containing certain foods – such as nuts, whole grains, seafood, fruits, and vegetables – are healthy, even though they are currently recommended as key components of a healthful diet.”

The Request for Information and Comments also highlights the following questions:

• Is the term “healthy” most appropriately categorized as a claim based only on nutrient content? If not, what other criteria (e.g., inclusion of foods from specific food categories) would be appropriate to consider in defining the term “healthy” for use in food labeling?
• If criteria other than nutrient content (e. g., amount of whole grain) are to be included in the definition of the term “healthy,” how might FDA determine whether foods labeled “healthy” comply with such other criteria for bearing the claim?
• What types of food, if any, should be allowed to bear the term ‘‘healthy?” Should all food categories be subject to the same criteria?
• Is “healthy” the best term to characterize foods that should be encouraged to build healthy dietary practices or patterns? What other words or terms might be more appropriate (e.g., “nutritious”)? FDA encourages submission of any studies or data related to descriptors used to communicate the overall healthfulness of a food product.
• What nutrient criteria should be considered for the definition of the term “healthy?”
• Should nutrients for which intake is recommended to be limited be included? Should nutrients for which intake is encouraged continue to be included?
• If nutrients for which intake is encouraged are included in the definition, should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population, or should they include those nutrients that contribute to general overall health? Should the nutrients be intrinsic to the foods, or could they be provided in part – or in total – via fortification?
• Are there current dietary recommendations (e.g., the Dietary Guidelines for Americans) or nutrient intake requirements, such as those described in the final rule updating the Nutrition Facts label or those provided by the Institute of Medicine (IOM) in the form of Dietary Reference Intakes (DRI) that should be reflected in criteria for use 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? What are consumers’ expectations of foods that carry a “healthy” claim? FDA is especially interested in any data or other information that evaluates whether or not consumers associate, confuse, or compare the term “healthy” with other descriptive terms and claims.
• Would this change in the term “healthy” cause a shift in consumer behavior in terms of dietary choices? For example, would it cause a shift away from purchasing or consuming fruits and vegetables that do not contain a “healthy” claim and towards purchasing or consuming processed foods that bear this new “healthy” claim?
• How will the food industry and consumers regard a change in the definition of “healthy?”
• What would be the costs to industry of the change?

Comments will be due within 120 days of publication of the Request in the Federal Register.

In the meantime, FDA released a guidance document explaining a new policy of enforcement discretion for certain products labeled as “healthy.” In particular, the guidance advises food manufacturers of FDA’s intent to exercise enforcement discretion (i.e., not enforce all elements of the current “healthy” definition) for two new categories of foods:

• Foods that have a fat profile of predominantly mono- and polyunsaturated fats, but do not meet the regulatory definition of “low fat;” and
• Foods that contain at least 10 percent of the Daily Value of potassium or vitamin D, rather than vitamin A, vitamin C, calcium, iron, protein, or fiber.

Either type of food should meet the other conditions of a “healthy” claim as set forth in the regulatory definition. FDA will accept public comments on this guidance at any time.

We will be closely monitoring the comments on the use of the term “healthy” and any related FDA action on this significant regulatory change.

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