What is a “healthy” food? Should a “healthy” food contain specific levels of vitamins and minerals? Conversely, should a “healthy” food limit potentially harmful components such as saturated fat, cholesterol, sugar or sodium? Questions surrounding the definition of a “healthy” labeling claim have surged in recent years due to the rising consumer demand for nutritious foods.

To address this labeling issue, the Food and Drug Administration (FDA) convened a meeting this month with industry stakeholders and consumer advocates. The meeting featured panel sessions, oral presentations and breakout sessions to facilitate a discussion regarding scientific data, consumer perceptions, and the current federal nutrition guidelines. Ultimately, the goal of the meeting was to reach a consensus supporting a revised definition and regulatory criteria for a “healthy” food labeling claim.

Since the early 1990s, the FDA has permitted the use of “healthy” and related terms as an implied nutrient content claim on food labeling. Under the current regulations, the agency permits the use of the claim “healthy” if a product satisfies “specific criteria for nutrients to limit in the diet, such as fat, saturated fat, cholesterol, sodium, as well as requirements for nutrients to encourage in the diet, including vitamin A, vitamin C, calcium, iron, protein, and fiber”(21 CFR 101.65(d)).

In September 2016, the agency requested public comments and scientific data related to the nutrient content claim. Industry input was needed to support the FDA’s efforts to redefine the term “healthy” to align with the new final rules for updating the Nutrition Facts Panel and serving size information for packaged foods.

Concurrently, the agency issued a guidance document in September entitled, Use of the Term ‘Healthy’ in the Labeling of Human Food Products (81 FR 66527). The final guidance advised food manufacturers of the agency’s intent to exercise enforcement discretion regarding the use of the implied nutrient content claim “healthy” relative to the latest recommendations. Within the guidance, the agency highlighted acceptable uses for the labeling term relative to low fat (dependent on the type of fat), and beneficial nutrients such as potassium and vitamin D.

The labeling guidance addressed certain changes mandated by the final rules for revising the Nutrition Facts Panel related to the use of nutrient content claims. Under the new rules, certain nutrients are no longer recognized to be significant issues for public health, including vitamins A and C.

The FDA suggested that discretionary enforcement would permit manufacturers to continue to market products with “healthy” claims meeting the existing regulatory definition. During the rulemaking process, the FDA will exercise enforcement discretion for a food bearing the “healthy” claim but not containing at least 10% of Daily Value (DV) per Reference Amounts Customarily Consumed (RACC) of the approved nutrients (21 CFR 101.65(d)) provided the food contains at least 10% of the DV per RACC of potassium or vitamin D, or for foods not low in fat, the fat must be predominately mono- and polyunsaturated fats.

The decision to update the criteria for a “healthy” nutrient content claim was prompted in part by a public petition from a company named in an FDA warning letter. In 2015, the FDA issued a warning letter regarding the use of the claim “healthy” on Kind nutrition bars. The warning letter indicated the saturated fat content of the bars exceeded the criteria for the nutrient content claim (21 CFR 101.65(d)(2)). Nuts are the main ingredient of the products and a leading contributor to the products’ fat content. The agency revoked its decision in May 2016.

Some industry stakeholders have suggested the FDA regulations for health claims and nutrient content claims should be updated to align with the latest nutritional science, including the recommendations published within the 2015-2020 Dietary Guidelines for Americans. The guidelines suggest a healthy diet for the average adult should be higher in vegetables, fruits, whole grains, low- or non-fat dairy, seafood, legumes, and nuts.

According to the guidelines, Americans should reduce their consumption of red and processed meat, added sugars, sodium, saturated fat, and refined grains. Polyunsaturated fat alternatives should replace saturated fats and solid animal fats should be replaced with non-tropical vegetable oils and nuts, according to the experts.

Since the publication of the guidance and notice, the agency received nearly 900 public comments related to the use of the labeling term. To support the revision of the regulatory definition, the September notice urged industry stakeholders to submit public comments and scientific data regarding the use of the term “healthy,” which will support the revised regulatory definition. In particular, the agency requested input regarding the following questions:

  • What types of food, if any, should be allowed to bear the term “healthy”?
  • What nutrient criteria should be considered for defining “healthy”?
  • How should the definition address nutrients that should be limited or encouraged in the diet?
  • Should the nutrients be intrinsic to the foods, or could they be provided in part – or in total – via fortification?
  • What costs would the industry incur as a result of the change?

The revised definition is a critical issue for the food industry since surveys have suggested the purchasing decisions of the majority of consumers are influenced by nutrient content claims on food labels. In fact, the FDA’s 2014 Health and Diet Survey (May 2016) indicated nearly 80% of consumers will review a product’s label prior to purchasing a food for the first time.

The FDA will accept written comments through April 26, 2017. To resolve this labeling conundrum, the agency will consider the results of the public meeting in conjunction with the hundreds of written comments submitted in response to the labeling guidance.

Food companies must balance consumer and government requirements in food labeling. This translates into increased pressures to ensure accurate and compliant nutrition labels. Mérieux NutriSciences offers complete nutrition labeling options for industry to ensure compliant labels with all federal regulations in the United States and Canada. We also offer food label review services for packaging artwork. Contact us to get started on your nutrition labeling!

Meet the Author

Patrick Kennedy
Information Services Manager, Mérieux NutriSciences

Patrick Kennedy is the Information Services Manager for Mérieux NutriSciences. He has over 15 years of food industry experience and has written extensively covering a wide range of food safety and regulatory subjects. He holds a MS degree in information science from the University of Illinois, and is a member of several industry organizations including AOAC, IFT and IAFP.

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