What is healthy? Comments flood in as FDA docket closes

Oldways: ‘It’s time we stopped tying ‘healthy’ to a formula of nutrients divorced from actual foods’

By Elaine Watson

- Last updated on GMT

What types of food, if any, should be allowed to bear the term ‘healthy?’
What types of food, if any, should be allowed to bear the term ‘healthy?’

Related tags Food Nutrition Fda

“If we were looking for an easy answer and widespread agreement on the definition of ‘healthy,’ we didn’t find it [at a public meeting last month],”observed the FDA in a blog post this week. So could it seriously consider banning the word from food labels altogether, as several commentators have advised?

One vocal proponent of this strategy is nonprofit food and nutrition education organization Oldways – best known for creating the Whole Grain stamp – which urged the FDA​ “not to endorse the use of the word ‘healthy’ at all, since overall diet determines health – not individual foods - and certainly not individual nutrients.”

In comments submitted to the FDA docket ahead of the April 26 deadline, it added: “As the FDA updates ‘healthy,’ Oldways recommends moving away from the outdated practice of tying ‘healthy’ to a formula of nutrients divorced from actual foods. The 2015-2020 Dietary Guidelines for Americans specifically advise a turn away from nutrient-ism and reduction-ism.”

Even the FDA’s new guidance “wouldstill result in a food like brown rice not qualifying to be labeled healthy,”​ noted Oldways: “No matter what combination of nutrient criteria FDA might mandate as healthy, it’s inevitable that a reductionist approach will result in efforts to game the system with fortified manufactured foods, while some whole, natural foods may fail to qualify.”

If you must define healthy, focus on whole or minimally processed plant foods

If the FDA has to come up a definition, it added, “Oldways recommends using it to highlight whole or minimally processed plant foods, which are especially encouraged in the 2015-2020 Dietary Guidelines for Americans ​[including fruits, vegetables, legumes/pulses, whole grains, vegetable oils if mostly unsaturated, herbs and spices, nuts, and seeds] instead of tying use of the word ‘healthy’ to a formula of nutrients.”  

These foods could be labeled ‘healthy’ only if they are sold as single-ingredient foods or with only water added; sold as combinations of qualifying single-ingredient foods such as a soup mix of dried beans, whole grains and spices; or sold with small amounts of salt, and no added sugar.

Food labeling regulations​ currently mandate that ‘healthy’ can only be used as a nutrient content claim to describe foods that contain 3g or less total fat and 1g or less of saturated fat per serving, with the exception of fish and meat. There are also limits on cholesterol and sodium content and threshold requirements for nutrients to encourage (vitamin A, C, calcium, iron, protein, fiber).

However, FDA now says that​ it will not enforce current regulatory requirements for products that use the term ‘healthy’ if they:

(1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or

(2) Contain at least 10% of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

Read the new guidance on ‘healthy’ claims HERE​.

Any attempt at a definition will fall short

Tim Redmond, a “natural and organic food industry veteran of 47 years​,” told the FDA​:  “Defining what is ‘healthy’ shouldn't be attempted because any attempt at definition will fall short and the potential for abuse in food marketing is simply far too great.”

Kind bars new

The FDA’s ‘healthy’ probe follows a row​ with snack bar maker KIND, which says rules requiring ‘healthy’ foods to meet the criteria for ‘low fat’ claims are outdated​ as they exclude high-fat foods we know to be nutritious such as nuts and avocados, but include low-fat sugary foods.

The FDA agreed​ to re-evaluate its conditions of use for 'healthy' nutrient content claims, and invited public comment ​on questions including:

  • What types of food, if any​, should be allowed to bear the term ‘healthy?’
  • What other words or terms might be more appropriate (eg. ‘nutritious’)?  
  • What do consumers understand as ‘healthy’ in relation to food?

Dr Marion Nestle: Honestly, why bother?

Dr Marion Nestle, Paulette Goddard Professor of Nutrition, Food Studies, and Public Health at New York University, meanwhile, said she was “opposed to all health claims on principle; foods are not drugs.”

She added: “The problem with all of this is that the criteria are inevitably arbitrary and easy to get around. We will end up with lots of products that meet the definition but are still junk foods or ‘better-for-you’ choices.  A better-for-you junk food may still not be a good choice.”


In an April 20 blogpost,​ Susan Mayne, PhD, Director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and Douglas Balentine, PhD, director of the Office of Nutrition and Food Labeling at CFSAN, wrote: “The range of opinions we heard​ [at a public meeting on healthy claims in March] underscores just how complex the process of revising the definition will be...

"Kind Snacks ​proposed, in part, that foods be defined as healthy if they contain a ‘meaningful amount’ of foods that comprise a healthy diet and that don’t contain low- or no-calorie sweeteners or synthetic colors.

"ConAgra​ presented a framework for defining ‘healthy’ by ranking foods based on their nutritional makeup, an approach that permits greater flexibility…

"The Center for Science in the Public Interest​ said that a healthy label shouldn’t be a marketing tool that helps marginally better processed foods compete with fruits, vegetables and other truly healthy foods.

"And The Academy of Nutrition and Dietetics​, after talking to its members, said it could not come up with a good definition for ‘healthy’ that FDA should adopt.”

Moms across America: ‘We determine healthy to mean 100% natural, from nature, not a lab’

 As with the public comments on ‘natural’ claims​, what is immediately striking about a large percentage of the comments submitted to the FDA docket is how heavily they rely on words such as ‘chemicals,’ 'natural,' ‘artificial’ and ‘processed,’ which themselves are not clearly defined in law.

They also reflect a shift in thinking about ‘healthy,’ from being narrowly focused on fat, sugar, calories or other nutrients, to reflect a more wide-ranging discussion about ‘artificial ingredients’ or GMOs, or how sustainable a product is, for example.

Moms across America: "We determine healthy to mean 100% natural, from nature, not a lab."

For example, advocacy group Moms across America, which is best known for its anti-GMO stance, argues​ that healthy food “must not only be determined by nutritional content,”​ adding: “That is an incomplete, inaccurate and irresponsible way to determine ‘healthy.’

“We determine healthy to mean 100% natural, from nature, not a lab- NO GMOs, NO man made synthetic, harmful chemicals, and NO artificial dyes, preservatives or additives which have ever shown to cause short or long term harm.”

It added:  “We ask the FDA to have integrity and responsibility and to classify ‘healthy’ as grown or raised naturally (in nature) not in a lab, fed or being Non GMO, pesticide-free, low in sugar, sodium, no transfats, no MSG, no carrageenan, and free of other harmful additives/preservatives/dyes.”

Here’s a taste of some of the submissions as the April 26 deadline approaches:

Kind LLC: First, food products making a ‘healthy’ nutrient content claim should contain a meaningful amount of foods that are part of a healthy dietary pattern and identify the source and quantity of the ingredient(s) supporting the meaningful amount requirement.

Second, the ‘healthy’ definition should not include thresholds for ‘good’ nutrients.

Third, the ‘healthy’ definition should include limits on nutrients to avoid (added sugar, saturated fat, trans fat, and sodium) if those nutrients are not intrinsic to the foods that are part of a healthy eating pattern.

Fourth, the ‘healthy’ definition should exclude food products that contain low- or no-calorie sweeteners, sugar alcohols, or synthetic color additives.

Justin Mervis, general counsel and head of regulatory affairs at Kind, tells FoodNavigator-USA: "When developing our comments, we intentionally set the bar high for manufacturers to be able to use the word 'healthy' on food products to ensure it’s a term used sparingly and one that consumers can trust. We’ve asked the FDA to establish appropriate requirements, including numerical limits, for a few of our guiding principles. Our hope is that once thresholds are solidified for these, it will be fairly straightforward for manufacturers to determine whether their food product meets the standard or not. Specifically for our first principle, it may require manufacturers to consider the weight of health-promoting foods in the context of other ingredients."

Asked about sweeteners, he said: "We believe that the use of low- or no-calorie sweeteners does not increase the nutrient density of a food products. While these ingredients can be consumed as part of a diet that is generally healthful, we don’t believe food products with these ingredients should bear a healthy nutrient content claim given the lack of clarity around their short- and long- term health effects."

Pete & Gerry’s Organic eggs: It’s terrible that one of nature’s most incredible, nutrient dense, whole foods [eggs] cannot be labeled as ‘healthy’ at a point in our country’s history when unhealthy eating has reached epidemic proportions.

Blue Diamond Growers​: Almonds have a lot of good fats and protein… The total fat is primarily comprised of mono- and poly-unsaturated fats. They have a good amount of dietary fiber. They have no cholesterol. They keep well and they are easy to transport for eating and snacking. The use of “healthy” should align with the use of FDA’s qualified nut health claims.

 The International Tree Nut Council Nutrition Research & Education Foundation: Current FDA regulations governing ‘healthy’ claims are outdated and do not align with the current US Dietary Guidelines or the latest scientific research supporting the contributions made by nuts in achieving an overall healthy dietary pattern.

The Mexican Hass Avocado Importers Association (MHAIA​): The existing definition limits the use of ‘healthy’ to foods that are low in total fat, among other restrictions, yet, at the same time, is inconsistent with federal dietary guidance and the evolving body ofscientific evidence supporting the health benefits of unsaturated fats like the type found in avocados.

James Partner​: As a professor of food marketing at St. Joseph's University in Philadelphia, I find this worthless effort to be a waste of time and taxpayer money. ‘Healthy’ refers to a consumer's diet... not the food. Food can be ‘nutritious,’ ‘wholesome,’ and even ‘natural.’ But food isn't healthy or unhealthy. Why is that so difficult to understand? ‘Part of a healthy diet...’ yes. ‘Healthy’ as a stand-alone descriptor of a specific food, no way.

Becca Zoeller – ‘Healthy’ means: food grown without toxic chemicals and not genetically modified; no hydrogenated oils or trans fats; minimally processed; no artificial ingredients; no refined sugars; no refined grains; no high fructose; made without table salt, but rather a salt taken from nature such as sea salt or Himalayan pink crystal salt. In other words, healthy food includes: organic ingredients; whole foods; healthy fats; whole grains and seeds; grass fed animals and animal byproducts; free range animals and animal byproducts; products made with only one or two processes from the whole food form; and, chemical-free.

Jonathan Hardy​: ‘Healthy’ food is food that is environmentally sustainable and beneficial plus biologically unharmful to the body's natural digestion…

Kelie Cichoski: Healthy should mean no chemicals, no preservatives that are not naturally occurring, no hormones, and no antibiotics.  

Peter Hoffman​: 'Healthy' should not be used as a marketing label at all. Such claims are always dubious and never allow for the fact that moderation in anything is important.​  

George Inashvili​: By far and away the most important definition of healthy is that it's true organic. Healthy is non-GMO… Healthy is elimination of sugar… Healthy is a mostly vegan, organic diet full of dark leafy greens, green teas, and plant protein.

Tami Hanke​: I​ don't think anything with any kind of added sugar can be regarded as ‘healthy.’

Barry Popkin, University of North Carolina, Chapel Hill: ​ We need to fit with both our US dietary guidelines and the WHO, which have set clear goals and guidelines… Food claims that focus on single nutrients mislead the public repeatedly… We must use a food group-based all-encompassing definition.

Read all the comments​ in the docket (deadline April 26, 2017).

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