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From Soup to Nuts: Science-based Recommendations for FDA’s “Healthy” Label

, Senior Analyst, Food Systems and Health | May 1, 2017, 2:49 pm EDT
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If you wanted to offer your two cents on how the US Food and Drug Administration (FDA) defines “healthy” food, you’ll have to keep those pennies in your pocket for now. The public comment period closed on April 26, and the people—more than a thousand in total—have spoken.

The comments represent a diverse range of perspectives. Some are purist, suggesting that all artificial colors or flavors, preservatives, and genetically engineered ingredients be excluded from foods bearing the “healthy” label. Others raise concerns about consumer (mis)interpretations of “healthy” and related terms, and recommend that its use on product labels be disallowed. Still others—primarily those representing various sectors of the food industry—advocate for flexibility in the regulations to accommodate existing products or provide adequate time for product reformulation.

As for UCS?

We pursued a science-based path to food-based criteria, emphasizing the importance of food groups in healthy dietary patterns, while also supporting limits for sugar, sodium, and fat. Some of these were no-brainers, and some were, quite frankly, tough nuts to crack. Here’s where the science steered us.

Food-based criteria are a must

Any food item labeled “healthy” should contain a substantial proportion of one or more health-promoting foods. We chose to define “health-promoting foods” generally as vegetables, fruits, whole grains, dairy (including nutritionally equivalent dairy substitutes), and protein foods. These categories largely reflect the Dietary Guidelines for Americans Key Recommendations for Healthy Eating Patterns. We also identified some specific foods that should be excluded from the healthy label: fruit juice, processed meat, and red meat. Fruit juice has a higher glycemic index than whole fruit and lacks equivalent fiber content, and is associated with a greater risk of developing type 2 diabetes. The World Health Organization’s classification of processed meat as carcinogenic to humans, and red meat as probably carcinogenic, provides the basis of their exclusion.

Photo: Lea Aharonovitch/CC BY SA (Flickr)

Establishing what constitutes a “substantial amount or proportion” of a health-promoting food is considerably more difficult. While there is some precedent for evaluating the healthfulness of foods (the Environmental Working Group Food Scores and the United Kingdom Department of Health’s Nutrient Profiling Model are good places to start), we lack substantive research to help us identify an amount that strikes the ideal balance between potential health benefits and practicality. Of course, the more health-promoting foods like fruits, vegetables, and whole grains we eat, the better; but a useful recommendation must also consider the full range of products that line our grocery store shelves and the habits and preferences of the people who buy them. Ultimately, should the FDA decide to adopt this method of classifying foods, it will need research that addresses this question.

A “healthy” food should be low in ingredients and nutrients associated with clear health risks

The inclusion of added-sugar limits in the FDA definition of “healthy” is long overdue. The 2015 Dietary Guidelines for Americans recommend that calories from added sugars contribute no more than 10 percent of total calories, while the American Heart Association limits calories from added sugar to less than seven percent of total calories for moderately active adults, and recommends that children under two avoid added sugar altogether. In keeping with the dietary guidelines, we propose that added sugar contributes no more than 10 percent of calories to a food labeled “healthy,” with greater potential health benefits offered by further reductions.

While the current definition of “healthy” identifies sodium limits for foods, research suggests that many Americans need more help staying below recommended daily levels. The current mean sodium intake in the US is 3,440 milligrams per day—that’s almost 150 percent higher than recommended intake of 2,300 mg per day. Research consistently demonstrates a strong relationship between sodium intake and risk of heart disease, which is the leading cause of death in the United States.

Given that processed and commercially prepared foods provide about 75 percent of our total sodium intake, it’s important that the FDA take this opportunity to set adequate sodium goals for packaged foods. While the available science does not point to one optimal sodium threshold for food items or prepared meals, we can confidently say this: sodium limits on food items should be reduced to help Americans meet daily sodium goals. And the forthcoming —currently being drafted by the FDA to help Americans meet sodium targets within 10 years—should inform these reductions with evidence-based recommendations.

Current science suggests the FDA reconsider limits on total fat

As a nation, we are slowly coming to our senses after a decades-long low-fat frenzy, as science has given us a much greater understanding of the role fat actually plays in chronic disease. We now know that the type of fat we eat may influence our health more than the amount. Research consistently shows that replacing saturated fats with unsaturated fats in the diet leads to lower total cholesterol (particularly the LDL, or “bad” variety) in the blood. The existing FDA definition of “healthy” limits total fat content but doesn’t distinguish between types—meaning heart-healthy foods like almonds don’t make the cut. To address this, we propose that foods with fat content higher than current allowable levels may still bear a “healthy” label if the majority of the fat is poly- or monounsaturated. (The catch? The fats need to come from one of the health-promoting food groups named above. Adding canola oil to cookies doesn’t count.)

Food labels are important, but they aren’t enough

With this rulemaking, the FDA has an opportunity to bring its “healthy” claim into better alignment with the latest scientific findings about health-promoting foods. But there are limitations to what even the best food label can achieve. Consumers may interpret the claim in different ways, or may find themselves more influenced by price or package design. Even in the best of circumstances, a nutrient content claim generally conveys information about a given food, but it doesn’t provide the context of a balanced and healthy diet.

That’s why public investment in nutrition programs—like the Supplemental Nutrition Assistance Program (SNAP), National School Lunch Program (NSLP), and Food Insecurity Nutrition Incentive (FINI) grant program—is so important when it comes to changing the tide of Americans’ diets and our nation’s health. As the FDA begins to build their definition of “healthy,” we continue our work in defending these programs in the federal budget and upcoming farm bill to ensure that, for all Americans, “healthy” can be a reality.


Photo: USDA

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  • Morton Satin

    This type of article is the reason why I quit the Union of Concerned Scientists. You may be concerned, but you are not scientists. Instead of reviewing the totality of peer reviewed published science, you cherry pick data to fit an anti-industry agenda in the same way that CSPI does. And your research is so facile! WHO policy states cutting back on salt, while their actual data published on their Global Health Observatory show that people consuming between 3-4.8 g of salt daily have the best health. WHO is political, you are not. You say you represent science, but you follow the standard anti-science anti-peer-reviewed approach that CSPI and the checkout counter newspapers do. So who represents honest science in this country?

    • Sarah Reinhardt

      Thanks for reading my post, Morton. I think we might be in agreement that reducing salt intake beyond a certain threshold may not produce better health outcomes. As Vice President of the Salt Institute, I’m sure you’re aware that sodium plays a critical role in many physiological processes, including fluid regulation and muscle function.

      Our comment to the FDA is rooted in the recommendations of a 2013 Institute of Medicine committee that examined an expansive body of research on dietary sodium intake and health outcomes, and our position reflects their conclusions. As the committee report states, “studies on health outcomes are inconsistent in quality and insufficient in quantity to determine that sodium intakes below 2,300 mg/day either increase or decrease the risk of heart disease, stroke, or all-cause mortality in the general U.S. population.” However, as indicated by the report, a large body of evidence strongly supports the positive relationship between high sodium intake and risk of cardiovascular disease and population-based efforts to curb dietary intake.

      In keeping with this review of the best available scientific evidence, we have therefore aligned our recommendations for use of the “healthy” claim with FDA industry sodium reduction goals that aim to reduce population intake to no less than 2,300 mg/day.

      • Morton Satin

        First of all Sarah, you impugn my comments by pointing out that I am the Vice President of the Salt Institute, suggesting I have a particular dog in the fight. Unfortunately, you, CSPI, and government bureaucrats can’t imagine that I’m doing it for the sake of the honest representation of science to consumers. Let me tell you my background and I will be happy to send you every scientific reference, for you to check out. In industry in1975 I introduced and patented the very first fiber supplemented product based upon our research in animal and human digestion. Now fiber supplementation is ubiquitous. In1976, I introduced folic acid and biotin supplementation based on the published nutritional need. It took the bureaucrats 20 years to make it universally mandatory. The industry considered me a traitor because I challenged the status quo. In 1988, as Head of Food and Agricultural-industries for FAO of the United Nations in Rome, I prepared the first commercially viable formulations for gluten free food (see New Scientist April 28, 1988) and in 1996, I obtained the patent for the shelf stable coconut water you now see everywhere. I donated the patent at no cost to FAO on condition that there would be no licensing fees to produce the product. It is now a $1.5 billion market, for which I did not obtain a penny (not even the proverbial dollar). As I said, all references are available.

        My opinion on salt is entirely my own and has nothing to do with any commercial aspects of salt. Many people do not have the imagination to think that someone who works in industry can do that, but let them compare their contributions made to the consumer with my own.

        The devil is always in the details. You have no idea how the 2013 IOM report came about. The CDC gave IOM money to do the report, figuring it would be a slam dunk for population wide salt reduction, in anticipation of the 2015 Dietary Guidelines. When I saw the original committe,it was clear that every single member had already made their position clear publicly in favor of salt reduction m, before they ever did the IOM study. The Committee was a kangaroo court. So I wrote a personal letter to the Presidents of the IOM and the National Academy of Science pointing this out and reminded them that if this is the way we intend to conduct science in this country, we might as well hand the science baton over to China. Three weeks later, the Committee was altered to include individuals that
        Had not come out publicly in favor of salt reduction. When you give scientists without an agenda a chance, the results come out very different than expected. This was the first IOM report that stated there was no strong evidence to support either side of the salt debate, yet the salt reduction advocates were rabid in promoting their agenda, which was never based on comprehensive health outcomes, but on a single digit systolic drop in BP for those limited number of individuals with uncontrolled hypertension.

        This was not science, it was politics that held the potential of placing the entire population at risk if salt reduction policies were implemented. Fortunately, this situation has changed dramatically in the last year,0 based upon new peer-reviewed evidence and there is now a universal call from both sides of the debate, published in the European Heart Journal in January 2017, for a large RCT based on overall health outcomes, not BP, and using multiple consecutive 24 hr urine collections, rather than a single one, which was falsely considered a gold standard in the past.

        As I said, the devil is in the details.