A KIND and Timely Nudge to the FDA on Food Labeling

This past spring, the U.S. Food and Drug Administration sent a letter to KIND, notifying the natural snack food company that the use of "healthy" on the packaging of four of its bars -- and, in some instances, on its website -- did not meet the agency's regulatory definition of the word. This made news at the time and, quite frankly, surprised the heck out of me. KIND bars have long been a staple in the Katz family pantry, and they have powered me through the ardors of many of my frequent flyer miles. I am quite confident my personal nutrition standards rival any at the FDA.

Looking into the matter at the time, I was motivated to contribute my perspective. My point of view then, as now, is that the FDA regulations are in clear need of an update.

The particular FDA regulation in question pertains to total fat content. On the books since the days when all dietary fat was "bad," which was of course never correct in the first place, the regulation indicates that a product cannot be called "healthy" if it exceeds a fixed amount of total fat per serving. Also in the regulation is a clause about saturated fat, for which there is a lower threshold. Compounding these restrictions is the notion that if the word "healthy" is applied to a food or product, it turns into a " nutrient content claim," meaning the word refers to some specific nutrient level, rather than the overall character of the food.

KIND was called out for its use of the word "healthy" on its packaging and many public health and nutrition experts rose up in the company's defense. The public debate that ensued highlighted a problem in the regulations that approximated a paradox. The concern about KIND bars was based solely on the fat content, and yet the fat in question was coming almost entirely from nuts.

Nuts are not just known to be healthy -- routine nut intake has been associated with a reduction in all-cause mortality. Nuts were on the short list of foods recommended in the 2010 Dietary Guidelines for Americans, and are once again on the list of highlighted recommendations in the 2015 Dietary Guidelines Advisory Committee's report. To the best of my knowledge, no one at the FDA or elsewhere is challenging the notion that calling nuts "healthy" is entirely appropriate. At this point, it's an established fact of modern nutrition.

But put those nuts into a bar with fruit, and because of the fat content of the nuts, the bar cannot be called healthy under current regulations.

When I first made just that observation, I had no formal ties to KIND, although the company had funded two studies in my lab. We have established just such ties since, however. I now serve as KIND's senior nutrition advisor, with opportunity to help guide a robust research agenda, and to have a hand in making an excellent product line even better.

What the role means at the moment is that I have some inside intelligence to share about the follow-up with FDA. Today, KIND is submitting a citizen petition, asking the agency to update its regulations related to product fat content, and to the notion that "healthy" is necessarily a nutrient content claim rather than a characterization of the product in general. The petition is supported by prominent nutrition experts and organizations with an interest in public health.

While application of the word "petition" could sound adversarial, it is not. KIND has had a collaborative dialogue with the agency. FDA regulations can be hard to change, and the citizen petition mechanism can actually help the agency move a matter up the priority list and get timely attention.

In this instance, the agency has good reason to welcome such a prod; its regulations are required to align with the Dietary Guidelines for Americans. The problematic regulations in this scenario diverge from the 2010 guidelines, and are at imminent risk of diverging even more blatantly from the new 2015 guidelines when they are released. In the 2015 Dietary Guidelines Advisory Committee's report, on which the new guidelines will be based, not only are nuts once again explicitly encouraged, but a recommended limit for total fat intake has been removed. Simply put, the existing FDA regulations have fallen behind and need to be made current.

This is a matter of genuine importance to public health nutrition for the most practical of reasons: A diet is made up of foods. While it is the overall dietary pattern that matters most to health, what we choose every day is not a dietary pattern, but what foods to eat. Ultimately, a good diet is comprised of wholesome foods in sensible combinations. To get there from here, food choices must be well-informed, and that's where the FDA enters the picture. If the labeling on individual foods is at odds with official dietary guidance, we wind up with a Catch-22: Eating certain foods that cannot be called healthy is recommended to achieve a healthy diet. We have more than enough unnecessary confusion about diet as is without the government contradicting itself.

KIND's citizen petition to the FDA addresses a matter bigger than the company's interests; it is also in the interests of public health. Labeling on foods and dietary guidance should align. KIND is providing the FDA a timely nudge to address the fact that at present, they do not.

David L. Katz, MD, MPH, FACPM, FACP, is the founding director of Yale University's Prevention Research Center; President of the American College of Lifestyle Medicine; Editor-in-Chief of the journal, Childhood Obesity; Chief Science Officer for NuVal LLC; and director of the Integrative Medicine Center at Griffin Hospital. A clinician, researcher, author, inventor, journalist, and media personality, Dr. Katz is the recipient of numerous awards and recognitions, including an honorary doctoral degree; widely supported nominations for the position of U.S. Surgeon General; recognition by Greatist.com as one of the 100 most influential people in health and fitness in the world for the past 3 years; and inclusion by LinkedIN as one of the original 150 INfluencers. He has authored over 200 scientific papers and chapters, 15 books, and well over 1,000 columns and blogs- with a resulting social media following of roughly 500,000. A two-time diplomate of the American Board of Internal Medicine, and a board-certified specialist in Preventive Medicine/Public Health, he is recognized globally for expertise in nutrition, weight management and the prevention of chronic disease. Dr. Katz has delivered addresses in numerous countries on four continents, and has been acclaimed by colleagues as the "poet laureate" of health promotion.