FDA Seeks to Redefine "Healthy" for Food Labeling

By: Anna M. Wiand, Associate in GrayRobinson's Regulated ProductsFood Law and Alcohol Law practice groups

TAMPA, FL -- October 21, 2016 --Recently, the U.S. Food and Drug Administration (FDA) initiated the process to redefine the "healthy" nutrient content claim for food labeling.  The Agency took two actions in what is sure to be a long process.  First, the Agency issued a Request for Information soliciting comments on establishing the criteria to determine when a food may claim to be "healthy."Second, the FDA issued a guidance document titled Guidance for Industry: Use of the Term "Healthy" in the Labeling of Human Food Products to advise food manufacturers of the Agency’s intent to exercise enforcement discretion for healthy claims related to certain fats and nutrients.However, the Agency stresses food manufacturers can continue to use the term "healthy" on foods that meet the current regulatory definition.

The current regulatory requirements for using "healthy" related claims are found in 21 C.F.R. 101.65(d)(2).  This regulation provides: "You may use the term "healthy" or related terms (e.g., "health," "healthful," "healthfully," "healthfulness," "healthier," "healthiest," "healthily," and "healthiness") as an implied nutrient content claim on the label or in labeling of a food that is useful in creating a diet that is consistent with dietary recommendations."  The food must also meet specific nutrition content levels prescribe by the rule, including specified conditions for fat, saturated fat, cholesterol, and other nutrients.

Although alcohol beverages are articles of food or drink which could be regulated by the FDA pursuant to the Food Drug and Cosmetic Act (FD&C Act), in accordance with a 1987 Memorandum of Understanding between the FDA and the Alcohol and Tobacco Tax and Trade Bureau (TTB), TTB is responsible for the promulgation and enforcement of regulations with respect to the labeling of distilled spirits, certain wines, and malt beverages pursuant to the Federal Alcohol Administration Act (FAA Act).However, TTB has determined certain beers, which are not made from both malted barley and hops but are instead made from substitutes for malted barley (such as sorghum, rice, or wheat) or are made without hops, do not meet the definition of a "malt beverage" under the FAA Act.These products are subject to the FDA’s labeling requirements. 5 Thus, beer manufacturers should monitor the FDA’s actions to update its existing regulations governing the use of the term "healthy."  

The Request for Information and the guidance document are just the initial steps in the FDA’s effort to redefine the term "healthy" for food labeling.  This initiative is long overdue as the FDA’s existing standards for using the term "healthy" date to 1994.  Furthermore, clarifying the term "healthy" is part of the Agency’s broad plan to provide consumers with information and tools to enable them to easily and quickly make food choices consistent with public health recommendations and to encourage industry’s development of healthier foods.  

In addition to the Agency’s stated goal of redefining healthy to bring its regulations in line with current nutritional science and the 2015-2020 Dietary Guidelines for Americans,6 this latest action may be a response to pressure from industry for clarity on the permissible use of the term "healthy."  The current definition has sparked litigation over Nature’s Way’s claims that coconut oil products are healthy and Campbell’s soup products that contain partially hydrogenated oils but are labeled as healthy.7

Additionally, in March 2015, FDA issued a warning letter to snack bar manufacturer KIND LLC because of its use of the term "healthy" on snack bars.8 However, a year later the Agency reversed its position permitting KIND to use the term "healthy" so long as it is part of the company philosophy and not a nutritional statement.9

Prior to the FDA’s reversal KIND filed a citizen petition with Agency "requesting the Commissioner of Food and Drugs to update the Food and Drug Administration’s (FDA’s) existing requirements related to food labeling to become consistent with current federal dietary guidance as set forth in the 2010 Dietary Guidelines for Americans and with the latest scientific evidence discussed in the Scientific Report of the 2015 Dietary Guidelines Advisory Committee (2015 DGAC Report)."10 Among other things, the Petition highlighted the fact that many foods currently recommended for consumption under these guidelines may not be labeled "healthy" under the FDA’s current standards.  This includes foods like nuts, avocados, olives and salmon. 

Request for Information and Comments

The recently issued Request for Information seeks stakeholder input on many of the issues raised in the KIND Citizen Petition.  In particular, to aid the Agency’s revision of the standards for healthy claims, the FDA seeks guidance on: 

  • 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 we 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’’)? 
  • 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 (see 81 FR 33742; May 27, 2016) or those provided by the Institute of Medicine (IOM) in the form of Dietary Reference Intakes (DRI) (http://www.nationalacademies.org/hmd/Activities/Nutrition/SummaryDRIs/DRI-Tables.aspx), 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? 
  • 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?

 

The Agency has indicated, in addition to the Request for Information, it will provide other forums for consumers to provide comments.11 However, the comment period for the Request for Information on the Use of the Term "Healthy" in the Labeling of Food Products started September 28, 2016, and closes January 26, 2017.   Comments may be submitted on http://www.regulations.gov to docket folder FDA-2016-D-2335.

Enforcement Discretion in Guidance for Industry

While input is collected and the Agency tackles the time-consuming task of updating its "healthy" regulations, the nonbinding guidance issued in conjunction with the Request for Information advises food manufacturers that the FDA intends to exercise enforcement discretion for foods with the "healthy" claim on their labels that: 

  1. Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or 
  2. Contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.    

The discretion related to fat content acknowledges current regulatory standards do not a line with the most recent dietary guidelines for the intake of dietary fats.  In particular, the Agency recognizes and facilitates the shift away from encouraging simply limiting overall fat intake to promoting the consumption of mono and polyunsaturated fats.  In accordance with this guidance document, food manufacturers will not face FDA enforcement action when they put "healthy" claims on foods that are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats.  However, to bear the "healthy" claim, the product’s nutrition labels must break down the types of fats inside food packages and demonstrate that unsaturated fats "constitute the majority" of the fat inside.

Similarly, the enforcement discretion afforded products labeled healthy with beneficial nutrients, recognizes that "[n]utrient intakes have shifted over time … and vitamins A and C are no longer nutrients of public health concern. The nutrients of public health concern now include potassium and vitamin D, in addition to iron and calcium."  Therefore, in accordance with the guidance document a food may be labeled "healthy" if it contains at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D even if it does not have the at least ten percent of the DV per RACC of vitamin A, vitamin C, calcium, iron, protein, or fiber.

As food manufacturers are well aware, the FDA’s actions related to "healthy" claims comes on the heels of the Agency’s changes to the Nutrition Facts Label and while the industry waits further clarification on "natural" claims.12 The next couple of years promise to provide changes for the way manufacturers label and mark products as well as the claims and information consumers see on their local grocery stores.

For more information regarding the FDA’s guidance on "healthy" product labeling, or for assistance in responding to the Agency’s Request for Information, please contact GrayRobinson’s  Food Law Group at foodlaw@gray-robinson.com or (866) 382-5132.

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1 Use of the Term "Healthy" in the Labeling of Human Food Products; Request for Information and Comments,  81 Fed. Reg. 66,562, available at: https://www.gpo.gov/fdsys/pkg/FR-2016-09-28/pdf/2016-23365.pdf (last visited Oct. 13, 2016).

2 Use of the Term "Healthy" in the Labeling of Human Food Products: Guidance for Industry, http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM521692.pdf (last visited Oct. 13, 2016).

3 Memorandum of Understanding 225-88-2000 between FDA and Bureau of Alcohol, Tobacco and Firearms. http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm116370.htm (last visited Oct. 13, 2016).

4 TTB Ruling 2008-3, July 7, 2008. http://www.ttb.gov/rulings/2008-3.pdf

5 Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm166239.htm (last visited Oct. 13, 2016).

6 Dietary Guidelines for Americans, 2015 – 2020, https://health.gov/dietaryguidelines/2015/guidelines/ (last visited Oct. 13, 2016).

Sherry Hunter et al. v. Nature’s Way Products LLC et al., 3:16-cv-00532 (S.D. Cal.) and Brower et al. v. Campbell Soup Co., 3:16-cv-01005 (S.D. Cal.) 

8 KIND, LLC, FDA Warning Letter, Mar. 17, 2016 available at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm440942.htm (last visited Oct. 13, 2016).

9 U.S. Food and Drug Administration, Statement on FDA’s Actions on Labeling of KIND Products, http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm500184.htm (last visited Oct. 13, 2016).

10 KIND LLC, Citizen’s Petition, Dec. 1, 2015, https://s3.amazonaws.com/kind-docs/citizen-petition.pdf (last visited Oct. 13, 2016).

11 U.S. Food and Drug Administration, Making sure ‘healthy’ means what it says on food packages, Food Safety News, Sept. 28, 2016, http://www.foodsafetynews.com/2016/09/making-sure-healthy-means-what-it-says-on-food-packages/ (last visited Oct. 13, 2016).

12 See generally, U.S. Food and Drug Administration, Changes to the Nutrition Facts Label, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm (last visited Oct. 13, 2016) and R. Blau and A. Wiand, FDAs Next Action On Defining "Natural" for Food Labeling Purposes Remains Unclear, https://www.gray-robinson.com/1004/article/post/1247/fda-next-action-on-defining-natural-for-food-labeling-purposes-remains-unclear (last visited Oct. 13, 2016).