The Term Has No Legal Definition but Is Often Used on Food Labels to Imply Wholesomeness

The 2020-2025 dietary guidelines explain that a healthy lifestyle – including a healthy diet – can help people achieve and maintain good health and reduce the risk of chronic diseases at all stages of life. The 2020-2025 dietary guidelines identify vegetables, fruits, dairy products, grains, protein foods and oils as essential components of a healthy diet (Ref. 1). However, more than 80% of Americans have eating habits low in vegetables, fruits and dairy products (Ref. 1). In addition, more than half of the population meets or exceeds the recommendations for total cereals and total protein foods, but does not meet the recommendations for subgroups within each of these food groups (Ref. 1). In 2019, 42% of teens and 39% of adults reported eating fruit less than once a day, while 41% of teens and 21% of adults reported eating vegetables less than once a day (Ref. 13). At the same time, most Americans exceed the recommended intake limits for added sugars, saturated fats and sodium, nutrients that should be limited in a healthy diet according to the 2020-2025 dietary guidelines (Ref. 1).

There is some evidence that excessive intake of these nutrients is associated with a risk of chronic disease. For example, diets low in saturated fat may reduce the risk of CVD (Ref. 7), and high sodium intake is directly linked to high blood pressure, a major risk factor for CVD (Ref. 9, 10 and 17). “Fortified” or “Fortified”: Can only be applied to vitamins, minerals, fibre and potassium. Must contain 10 percent or more of the recommended daily value than a comparable food. Unfortunately, these warnings do little to deter consumers. And as long as foods don`t cross the line in a “disease report” (implying that fiber in oatmeal, for example, can treat high cholesterol — rather than “reduce”), manufacturers can use these claims without alerting the FDA or getting approval in advance.

Finally, as already mentioned, the current definition of health includes a nutrient intake criterion that focuses on nutrients that are sufficiently important to public health to warrant inclusion in nutrition labelling and that have been highlighted by key health authorities as being important for public health (59 FR 24232, 24243). When the existing “healthy” regulations were finalized in 1994, the nutrients included in the nutritional contribution requirement were vitamin A, vitamin C, protein, iron, calcium and fibre. Nutrient intake has changed over time, and vitamins A and C are no longer considered important nutrients for public health because nutrient deficiencies are rare in the U.S. population and are not currently a major public health problem. In our last nutrition label updates, we required the declaration of vitamin D and potassium, but no longer the declaration of vitamins A and C (81 FR 33742 to 33744). These updates are consistent with the 2020-2025 dietary guidelines, which, in addition to iron, contain calcium, potassium, fiber, and vitamin D as health-related nutrients for certain population groups (Ref. 1). In addition to moving from individual eating to healthy eating habits as the primary means of getting proper nutrition, there have been some changes in federal dietary guidelines regarding individual nutrients since the original “healthy” rule.

In September 2016, we also approved the installation of a waybill (Docket No. FDA-2016-D-2335) for information and comments (Request for Information or RFI) on the use of the term “healthy” in food labeling (81 FR 66562, September 28, 2016). In the request for information, we invited interested persons to comment on the Kind Citizen petition; the use of the term `healthy` as an indication of nutrient content in the labelling of foodstuffs intended for human use; and whether, if so, the use of the term “healthy” may be incorrect or misleading. We also solicited input on 12 specific questions and asked interested parties to provide supporting data, consumer research and other information to support their comments and responses to our questions. In collaboration with the RFI, we held a public meeting on March 9, 2017 entitled “Use of the term `healthy` in the labelling of food intended for human consumption” (ref. 13). The purpose of the public meeting was to provide an opportunity for interested persons to discuss the use of the term “healthy” in food labelling. Reference values are percentages of DV for each nutrient to ensure flexibility and longevity of “healthy” criteria as DVs change in the future. DVs are reference amounts of nutrients that must be consumed or not exceeded each day. In the past, FDA-regulated DVs were based on the nutritional needs of adults and children 4 years of age and older. However, recent revisions to nutrition label rules have introduced DVs specifically for infants up to 12 months of age and for children aged 1 to 3 years (§ 101.9 (c) (9)). As mentioned earlier, we suggest that the use of “healthy” nutrients be limited to adults and children 2 years of age and older.

Therefore, the claim “healthy” could appear on foods intended for children aged 2 to 3 years and on foods intended for adults and children aged 4 years and older. In determining whether the “healthy” claim is appropriate for use, particularly whether a food meets the “percentage DV” criteria for saturated fat, sodium and added sugars, the “Percentage DV” criteria are based on the set of DVs that are appropriate for that food. For most foods, DVs for adults and children aged 4 years and older form the basis of the nutritional criteria for the claim discussed in the following sections. However, for the subset of foods specifically targeting children aged 2 to 3 years (e.g., fruit bags, toddler snack poufs), the nutritional criterion of “DV percentage” is based on the specific set of DVs established for that age group in section 101.9(c)(9). Some consumer and industry and health agency comments from Start Printed Page 59174 were reluctant to accept the idea of a “health” nutrient content claim. Their main concerns were that the term “healthy” could be too simple, discourage consumers from further examining the nutrient content of a product, lead to excessive consumption of “healthy” products, or mean different things to different consumers (e.g., some consumers may not understand “healthy” in a nutritional context, but refer to other aspects of the product, such as its production method (e.g. organic)).