This is the first of two blog posts about the flaws of the FDA dietary recommendations and why we chose not to play “the FDA Label Game” while crafting Ample.

“Hey Connor, you once mentioned not liking the FDA’s nutritional recommendations. Can you elaborate? What’s wrong with the FDA’s daily values? How has it affected the way you created Ample?”
— Kumar, San Francisco, CA

We encounter the FDA’s daily values so regularly that they’ve been baked into us. But it’s a useful exercise to look at how these recommendations were created in the first place—are we blindly trusting something that rests upon a shaky foundation?

Talking about food policy, like all politics, can easily devolve into a heated and polarized debate. So I’ll say upfront that my intent with this post is neither to incite people to grab their pitchforks and charge on Washington, nor to excuse poor food policy. It is simply to point out that the daily value recommendations on the back of our food is a suboptimal gauge for our health. The FDA could be an incredible tool for the American consumer: a means to push food producers to make products that help keep the population in optimal health. But, as is too common in bureaucratic bodies, the agency’s issues arise from misplaced influence, a difficulty in pivoting, and rigid standards based on questionable science. And, unfortunately, we’re all affected by the FDA’s flaws.

The Demonization of Saturated Fat

Let’s start with saturated fat. The daily value for this nutrient is 20g: an innocuous number in and of itself. Yet we’ve been made to fear the single-bonded fatty acid like the plague. But why?

Unfortunately, the demonization of saturated fat rests on political intervention being placed ahead of proper science.

You may have heard the infamous story of Ancel Keys, a charismatic researcher out of the University of Minnesota, who in 1956 hypothesized that cholesterol and potentially saturated fat were the causes of heart disease after noticing that businessmen in America had higher levels of disease than those of post-war Europe. He decided to conduct the Seven Countries Study—a huge prospective study meant to verify his conclusion—and found what looked like a straight-line correlation between saturated fat intake and the rate of heart disease. He noticed that the countries with the highest saturated fat content had the highest incidents of heart disease. This was not a small study—the initial cohorts measured 12,763 patients over 15 years . Nail in the coffin for saturated fat, right?

Not exactly. It turns out there were actually many issues with Keys’s practices. Keys had the data for 22 countries, but chose to only include the 7 countries whose data fit his goal: a straight-line graph that would incriminate saturated fat. In fact, the correlation between saturated fat and coronary heart disease was actually much more dubious¹. Keys himself admitted that sucrose (sugar) could have had some effect, but never performed the second half of the multivariate correlation to be sure². Other researchers in his day like John Yudkin, George Campbell and Thomas Cleave vocally pushed back even before the study came out.

But Keys was a magnetic character with many political connections, and was able to get his interpretation pushed through the government. Thus, starting in the 1970s, the edict of low fat was hammered into our understanding of nutrition. One scientist’s charm and questionable practices has led to a half century of misinformation about fat in this country.

Even today, despite evidence to the contrary³, the political inertia of 50+ years of FDA recommendations has calcified the organization’s stance on saturated fat. How would our perception of fat differ if John Yudkin’s legacy had won out over Keys? We can never know. Keys’s findings continue to be hotly debated—the truth of the study is not the point of my argument. Instead, I’m trying to point out the flaw in letting any one person and one study have the power to dictate the next 50 years of health recommendations from the biggest food governance organization in the world. One man’s magnetism should never lead to two generations of misplaced fat-phobia.

The Sluggish Adoption of K2

Even when the science is solid and the FDA has the best of intentions, the agency’s glacial process of change can keep the daily recommendations out-of-date. Take for example, the case of Vitamin K2.

Vitamin K2 is responsible for directing the flow of calcium within the body⁴. Since 1995, the Ministry of Health in Japan has approved K2 for the treatment and prevention of osteoporosis, and in 2004, Vitamin K2 was shown to be associated with a significantly reduced risk of coronary artery disease⁵. But at a time when both osteoporosis and coronary heart disease are among the most common diseases in America, Vitamin K2 continues to be left without a recommended daily value.

Part of the issue seems to be that Vitamin K1 and K2 look very similar chemically. Vitamin K1, vital to your body’s ability to form blood clots ⁶, has been studied since the 1930s and converts (in small quantities) into K2. Despite mounting evidence, the FDA has been painfully slow on creating a new daily value for vitamin. In fact, it was only as recently as 2006 that the FDA, along with researchers from Tufts University, did analysis on common foods to determine K2 levels.

As long as Vitamin K2 remains without a daily value recommendation, the ambiguous “Vitamin K” that is put in multivitamins and added to fortified food products is almost exclusively K1. Vitamin K1 is cheaper and easier to find, which means manufacturers almost always opt for it over K2.

We need the FDA—the agency can use its health guidelines to push producers to make truly healthy foods for the American consumer. As simple a step as separating the K Vitamins into K1 and K2 would force everything from multivitamins to health shakes and drinks to focus on providing Americans with enough of the valuable vitamin. But it takes too long to incorporate the new science and, unfortunately, it’s consumers who pay the price.

The Misdefinition of Healthy

Now, if you’re not one to read the percentages of food labels anyway, then the flaws of dietary recommendations may seem like a non-issue. But there are tangible effects of these FDA nutrition guidelines on our lives. Health food is a hundred billion dollar industry, and a huge percentage of Americans work to “eat healthy”. Unfortunately, it’s becoming harder to know what that means.

The FDA actually has a legal definition of “healthy” which must be met if a food company wants to claim their food is “healthy”. Which again seems like a valuable idea—the agency should be a safeguard against false claims. Unfortunately, the FDA’s definition of healthy is based on outdated or politically motivated “science”, leading the whole industry to aim toward incorrect standards.

To the FDA, a “healthy” food must be⁷:

• Low Fat — 3g or less per 100g, and not more than 30% of calories from fat
• Low Saturated Fat — 1 g or less per 100 g and less than 10% of calories from saturated fat
• Less than 480 mg sodium
• Less than 60mg cholesterol
• At least 10% of the DV of vitamin A, vitamin C, calcium, iron, protein or fiber.

Incredibly, while “healthy” foods must be low fat, there is a conspicuous lack of sugar in this definition. The result is that fruit juices and shakes are sold as healthy options while being packed with more sugar than Coca-Cola. At the same time, naturally nutritious foods such as coconut and cacao beans are unable to be called “healthy” due to their fat content. An incorrect definition of “healthy” is more dangerous than no definition at all—it leads to the creation of incorrect conventional wisdom, which is hard to unlearn.

The issue of the “healthy” definition was brought into public scrutiny in late 2015, when KIND Bar received a warning letter from the FDA for calling the bars healthy. Amazingly, it was the whole almonds in their bars—the nut lauded as a superfood— that had pushed the fat content over the FDA’s 3g threshold. Understandably, Kind Bar petitioned the FDA over the “healthy” claim⁸ hoping to amend the outdated standard. The jury is still out on the petition.

Taken With A Grain of Salt

There is an absolute benefit in having food labels with nutritional values—they can give busy people a quick set of metrics from which to judge the health of the particular food. But there is danger when the institution tasked with telling us what’s healthy becomes too slow to pivot to new science and too pliable to politically connected interests. In a perfect world, we would be able to trust the facts on the back of our food intrinsically. With Ample, I’ve strived to do my own research so I’m not beholden to the FDA guidelines when crafting the formula. Though I read them all, as a matter of practice, I choose to take the FDA recommendations with 27mg of sodium.

In the next post, I’ll explain why we’ve decided against playing “the FDA Label Game.”

The conclusions of the Keys study itself are still hotly debated. For more reading, check out this link.

1.  Yerushalmy J, Hilleboe HE. Fat in the diet and mortality from heart disease. A methodologic note. NY State J Med 1957;57:2343–54.
2. Lustig, Robert, M.D., M.S.L. (2012). Fat Chance: Beating the Odds Against Sugar, Processed Food, Obesity, and Disease, Plume (Penguin), ISBN 978-0-14-218043-3, pp. 110-111.
3. Meta-analysis of prospective cohort studies evaluating the association of saturated fat with cardiovascular disease
4.  Effects of the Blood Coagulation Vitamin K as an Inhibitor of Arterial Calcification
5.  Dietary Intake of Menaquinone Is Associated with a Reduced Risk of Coronary Heart Disease: The Rotterdam Study
6. Vitamin K: the effect on health beyond coagulation – an overview
7.  Guidance for Industry: A Food Labeling Guide
8.  KIND’s Citizen Petition