This week, the U.S. Food and Drug Administration (FDA) issued guidance addressing Use of the Term “Healthy” in the Labeling of Human Food Products. The guidance represents a significant, though not complete, victory for those who have been working with FDA to bring its current regulations in line with the most up-to-date dietary guidelines concerning fat content in food. According to the guidance, effective immediately, FDA will exercise enforcement discretion so that:
- A food may be labeled “healthy” even if it does not meet the current low fat requirements for a “healthy” nutrient content claim in 21 C.F.R. § 101.65(d)(2), provided that (1) the amounts of mono and polyunsaturated fat are declared on the label AND (2) the amounts declared constitute the majority of the fat content; and
- A food may bear a “healthy” claim even if it does not contain 10% of the Daily Value (DV) per the reference amount customarily consumed (RACC) of vitamin, A, Vitamin C, calcium, iron, protein, or fiber as currently required by 21 C.F.R. § 101.65(d)(2) if it contains at least 10% of the DV per RACC of potassium or vitamin D.
The guidance does not change the other requirements for making a “healthy” claim.
The Debate: Are Nuts (and Other Sources of ‘Good’ Fat such as Avocados) Healthy?
Early last year, FDA started a very public debate with KIND LLC regarding whether four of its popular snack bars were properly described as “healthy” in product labeling and on the company website. Founded in 2004, KIND LLC markets snack products containing whole nuts, fruits, and whole grains. The company’s core philosophy is that snacks should be both “healthy and tasty.” However, as noted in the March 17, 2015, FDA Warning Letter issued to KIND, many of KIND’s snack products do not meet the current regulatory requirements for a “healthy” nutrient content claim under 21 C.F.R. § 101.65(d)(2) because they are not low in fat.
As KIND quickly pointed out, the reason its snacks are not low in fat is because they contain nuts, a food that provides significant nutritional benefits according to the latest scientific research. See April 14, 2015 Blog, A Note to Our KIND Community. After evaluating the company’s response, FDA issued a closeout letter permitting KIND to continue making “healthy and tasty” statements in text that is “clearly presented as part of its corporate philosophy where it isn’t represented as a nutrient content claim, and does not appear on the same display panel as nutrient content claims or nutrition information.” See FDA Statement on FDA’s Actions on Labeling of KIND Products.
The KIND Petition
The KIND warning letter ignited a public debate about exactly what “healthy” means. In December 2015, KIND filed a citizen petition asserting that FDA should update its food labeling regulations to make them consistent with the 2010 Dietary Guidelines for Americans and the evidence in the Scientific Report of the 2015 Dietary Guidelines Advisory Committee. KIND requested that FDA take five concrete steps:
- Amend 21 C.F.R. § 101.65(d)(2) to exclude fat contributed by healthy whole and minimally processed foods such as fruits, vegetables, nuts seeds, legumes, whole grains, and seafood. KIND Petition at 3.
- Define a “dietary guidance statement” as a statement in food labeling about the usefulness of a food, or a category of foods, in maintaining healthy dietary practices.”
- Amend regulations for “general nutritional claims” at 21 C.F.R. § 101.65(d)(1) so that a labeling claim would be considered an implied nutrient content claim only if the claim is “immediately adjacent to an implicit claim or statement about a nutrient.”
- Amend 21 C.F.R. § 101.65(b) to clarify that a dietary guidance statement about the usefulness of a food or a category of foods in maintaining healthy dietary practices is not a nutrient content claim unless the claim is an implied nutrient content claim because it is “immediately adjacent to an explicit or implicit claim or statement about a nutrient.” KIND Petition at 4-5.
- Issue guidance addressing these issues. KIND Petition at 5.
Although FDA has not yet responded to the KIND Petition, the petition prompted FDA to open a docket requesting public comments on use of the term “healthy.” See 81 Fed. Reg. 66562 (Sept. 28, 2016). Comments to the docket are due by January 26, 2017. FDA also issued the guidance described generally above and in more detail below that addresses KIND’s immediate concerns about using the “healthy” claims for products that are not low in fat.
The Guidance
Although the guidance document released this week does not address all of the issues raised in the KIND Petition, and does not exclude fat from whole sources such as nuts as KIND requested, it does respond to the shift in the 2015-2020 Dietary Guidelines for Americans, which no longer recommend limiting overall fat intake, and instead focus on increasing intake of polyunsaturated fat and monounsaturated fats and decreasing intake of saturated fat and trans fat. Guidance at 5.
As announced in the guidance, effective immediately, until FDA has the opportunity to amend 21 C.F.R. 101.65(d)(2), it intends to exercise enforcement discretion with regard to the nutrient content claim “healthy” as follows:
- Foods that use the term “healthy” that are not low in fat should consist predominantly of mono and polyunsaturated fats, that is, the sum of monounsaturated fats and polyunsaturated fats must be greater than the total saturated fat content. The amounts of mono and polyunsaturated fats must be declared on the label AND the amounts of mono and polyunsaturated fat declared must constitute the majority of the fat content.
- Prior to issuance of the guidance, foods that made “healthy” claims had to contain at least 10% of the DV per RACC of vitamin A, vitamin C, calcium, iron, protein, or fiber. 21 C.F.R. § 101.65(d)(2)(i). Since vitamins A and C are no longer nutrients of public health concern, and potassium and vitamin D are now among the nutrients of public health concern, a food can now bear a “healthy” claim even if it does not contain 10% of the DV per RACC of vitamin, A, Vitamin C, calcium, iron, protein, or fiber as required by 21 C.F.R. § 101.65(d)(2) if it contains at least 10% of the DV per RACC for potassium or vitamin D.
- Manufacturers who have not yet updated Nutrition Facts labels may use the old DVs for potassium and vitamin D. However, if a manufacturer has already implemented the updated label, the new updated DVs for potassium and vitamin D should be used. If a food is basing its eligibility for a “healthy” claim on its potassium or vitamin D content, the nutrient supporting the claim should be declared on the Nutrition Facts label.
- The guidance does not modify the other requirements for making “healthy” claims.
This represents a significant victory for KIND and for other industry stakeholders advocating for making FDA nutrition regulations consistent with the most up-to-date scientific research, and is potentially an important step in the evolution of the regulatory definition of “healthy.”
By Celeste Wheeler