By Lorrie Baumann
The Food and Drug Administration has decided that the agency will not enforce a regulation that the agency has interpreted to limit the use of the word “healthy” on food labels in a way that excludes products like some of KIND’s nut and seed bars. The new guidance from the FDA represents only the agency’s current thinking on this topic, and it’s intended to fill a gap between changing understanding about the role of fats in a healthy diet and a regulation that many said was stuck in the past.
Under the new guidance, FDA will allow foods to say they’re “healthy” on their labels if they’re not low in total fat but have a fat profile that’s predominantly mono and polyunsaturated fats or contain at least 10 percent of the daily value of potassium or vitamin D in the amount of the food that would be customarily consumed. “We’re encouraged by the speed of progress within the FDA and see this as a notable milestone in our country’s journey to redefine healthy,” said KIND Founder and CEO Daniel Lubetzky.
This change in thinking comes partly as a result of KIND’s urging the agency to take another look at the issue after the FDA sent the company a warning letter in March that the labels of its KIND Fruit & Nut Almond & Apricot, Kind Fruit & Nut Almond & Coconut, KIND Plus Peanut Butter Dark Chocolate + Protein and Kind Plus Dark Chocolate Cherry Cashew + Antioxidants bars were misbranded because the labels included the word “healthy.” Under the FDA rules at that time, a food had to contain no more than 15 percent of its calories from saturated fat, and the agency noted that the products didn’t meet that criterion. The FDA had a few other quarrels with the labels – among them that KIND had listed its address as its post office box instead of its street address. KIND fixed its labels to comply with FDA requirements, resulting in a stand-down from the agency with a closeout letter on April 20. “The FDA concluded that KIND satisfactorily addressed the violations contained in the warning letter,” according to the agency.
Following receipt of the closeout letter, KIND requested confirmation that it could use the phrase “healthy and tasty” in text clearly presented as the company’s corporate philosophy rather than in the context of an actual nutrient claim for any particular product. “The FDA evaluates the label as a whole and has indicated that in this instance it does not object,” the agency decided, and then followed up with a notice that the newest nutrition research, reflected in the “2015-2020 Dietary Guidelines,” as well as a citizen petition requesting a reevaluation of regulations regarding nutrient content claims suggested that the time had come for the agency to take another look at the issue.
KIND reinstated the word “healthy” on its wrappers. “Earlier this year, the FDA closed out a warning letter issued to KIND in March 2015 affirming that we could use healthy on our wrappers again – just as we had it before – in connection with our corporate philosophy,” said Justin Mervis, KIND’s Head of Regulatory Affairs.
The agency’s next step will be a re-evaluation of the regulatory criteria for use of the implied nutrient claim “healthy” in light of the latest nutrition science and the current dietary recommendations and the seeking of input on how to update the existing regulations for this claim. ”The FDA has posed a number of important questions for comment, and in our continued efforts to advocate for public health, we’re actively convening experts to help provide answers grounded in current nutrition science,” Lubetzky said.
In the meantime, KIND won’t be taking advantage of the FDA’s decision not to enforce current rules, according to Mervis. “At the moment, we have no plans to use healthy in other contexts in reliance of the FDA’s enforcement discretion,” he said. “For us, healthy has always been more than just a word on a label – it’s a commitment to making wholesome snacks that consumers can feel good about putting in their body.”