Will the FDA’s Picture of “Health” Match Ours?

, science and policy analyst, Center for Science and Democracy | February 3, 2017, 3:09 pm EST
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As we enter month two of 2017, our New Year’s resolutions of leading healthier lives might be starting to plateau. But that of course depends on how we are defining “healthy.” What’s healthy to me might not be the same kind of healthy to you. My vision of a healthy day done right might be eating a Sweetgreen salad for lunch and walking back and forth to the metro, while yours might entail a ten-mile morning run and a steak dinner.

What does the Food & Drug Administration (FDA) consider “healthy”? Well, the agency currently has an open comment period asking the public to weigh in on how it should redefine the term to stay up to date with evolving nutrition science. You would think that the FDA’s definition of “healthy” would be a bit more straightforward, since it has a wealth of consumption and nutrition data at its fingertips. However, in draft guidance to industry on the term “healthy,” the FDA has so far failed to include added sugar as an ingredient that can only bear a “healthy” claim if it meets an enforceable limit, despite the scientific consensus surrounding added sugar’s role in chronic disease risk. And depending on who ends up being appointed to run the FDA, the definition of “healthy” could be scrapped completely if it’s deemed too burdensome for food manufacturers (more on that later).

What’s “healthy,” anyway?

Under the FDA’s current definition, in order to bear a “healthy” claim on a food package, a food must have at least 10 percent of the daily reference value (DRV) for at least one of either vitamin A, vitamin C, iron, calcium, protein or fiber and not have more than a certain limited amount of fat, saturated fat, sodium, and cholesterol. Unacceptably high levels of these ingredients, known as disqualifying levels, bar a food from being labeled as “healthy.” Notably absent from the list is added sugar.

How does this play out at the grocery store? Well, have you ever reached for a box of cereal with a big “healthy” claim on the front, only to find out that it has more sugar in a serving than you might like to eat in an entire day? This is entirely common, and especially concerning given the fact that these claims are allowed on packages for children as young as two years old. And it is these kinds of deceiving claims that contribute to the excess amount of added sugars that Americans consume every year.

The FDA must take further action to protect consumers from misleading food claims

That is why we submitted a citizen petition to the FDA last week to ask that the agency set a disqualifying level for added sugars that would apply to nutrient content and health claims, including the term “healthy.” Over 30,000 men and women across the country signed onto our petition in support of this measure!

It’s high time that the agency take action to protect consumers from misleading statements about the health of a product with regard to added sugar. There should be a clear limit on added sugars deemed by food manufacturers to be “healthy” to help consumers navigate the food environment that has become chock full of sugar. A brand new U.S. Department of Agriculture Economic Research Service report looking at trends in food and nutrient availability data revealed that Americans are still eating far too much added sugar: about 366 calories (23 teaspoons) per day, which is 83 percent higher than the Dietary Guidelines recommended limit of no more than 10 percent of calories (less than 200 calories or 12.5 teaspoons per day).

While President Trump’s “2 for 1” executive order will certainly make rulemaking an even tougher lift for agencies, as they’ll have to get rid of two rules for every new rule issued, the FDA should continue to build on its progress around added sugar. Just last May, the agency released its nutrition facts label revisions that created daily reference values (DRVs) for added sugar so that new labels will include a discrete line for added sugars beginning in July 2018.  Now that the FDA has set DRVs for added sugar, and overwhelming evidence—supported by leading medical and public health organizations like the American Heart Association, the American Academy of Pediatrics, and the World Health Organization—has illustrated that excessive added sugar consumption is linked to several chronic diseases, the FDA has the science on its side and the authority to add a disqualifying level for added sugar.

A strong FDA means a healthier America

The science certainly supports the FDA moving forward with this commonsense measure on added sugar, but the political reality is that the Trump administration seems to be fairly uninterested in science-informed policies so far. Last week began with scientists at agencies like the EPA and USDA being told by leadership not to communicate their taxpayer-funded scientific findings with the public and that there would be a freeze of hiring, grants, and contracts at the EPA. And then earlier this week, President Trump signed an executive order requiring that agencies must eliminate two rules for every one new rule issued (which is likely illegal, according to UCS president Ken Kimmell). All of these directives have a chilling effect on federal scientists, with the “2 for 1” order forcing agencies to make impossible choices between protecting the public from one threat to their health versus another.

The Trump administration’s cabinet selections haven’t been heartening, either. Whether it’s the climate denying and EPA-suing Scott Pruitt or the agribusiness-supporting Sonny Perdue, it’s looking pretty clear that the corporate cabinet will favor industry talking points over actual science to inform policies. The FDA commissioner has yet to be nominated, and while this job usually goes to someone with a science background and an interest in protecting public health, the Trump administration appears to be focusing its search on individuals with experience working in the biotechnology industry, advised by venture capitalist, Peter Thiel, who has some pretty radical ideas about how to run the FDA more like a Silicon Valley startup. Some of the names that have been mentioned as being in the running for FDA commissioner include Thiel’s associate Jim O’Neill, American Enterprise Institute fellow Dr. Scott Gottlieb, executive director of Lewis Center for Healthcare Innovation and Technology Dr. Joseph Gulfo, and former biotechology company executive Dr. Balaji Srinivasan.

This shortlist of men is riddled with conflicts of interest in their former and current ties to biotechnology companies, and features a man who thinks drugs should be approved if proven safe, regardless of efficacy (O’Neill), a man who has criticized the FDA for being too restrictive in its regulations (Gulfo), a man who has claimed that FDA regulations have nothing to do with health and are merely “safety theater” (Srinivasan), and a man who has accused the FDA of “evading the law” due to an overregulated drug approval process (Gottlieb). Note that none of these men have expertise in the food and nutrition space, and it seems like any regulation that inhibits the ability of drug or food manufacturers to approve and introduce an endless stream of new drugs and food additives will be unpopular under this administration.

Whether it’s one of these men or not, whoever is selected to lead the FDA must respect the role of public servant and abide by the agency’s mission to first and foremost “protect public health,” guided by science, not by drug and food manufacturers’ interest in increasing their quarterly earnings. In this case, there’s only one way to define a “healthy” public, and that’s one whose safety and well-being is protected over the profits of Big Pharma and Big Food. Taking further action to regulate added sugar amounts on front of package labels would be a strong science-backed policy maneuver that will advance the crucial fight against obesity and help all Americans make clearer decisions to improve their health. That’s my kind of “healthy.”

Join UCS and urge the FDA to include a limit for added sugar in its “healthy” definition by submitting a comment on regulations.gov before April 26.

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  • solodoctor

    I hope I am wrong but I doubt Trump will nominate someone to be the FDA Director who even cares about science based decision making. The last Congress passed legislation which allows the FDA to approve drugs with less scientific evidence than before. This current Congress will be even less inclined to consider the need for scientific based policy making.

    • Genna Reed

      I hope you’re wrong, too, solodoctor. It is in President Trump’s best interest to nominate an FDA commissioner who strongly values the role that science plays in policymaking.