In a March 17 warning letter to KIND, the FDA highlighted multiple violations of labeling laws, most of which were minor technical errors that the company agreed to address.
However, the section that attracted the most attention referred to the conditions of use for the term ‘healthy’, with the agency noting that selected KIND bars (which contain a lot of nuts) “do not meet the requirements for use of the nutrient content claim ‘healthy’” as they contain more than 1g of saturated fat per Reference Amount Customarily Consumed (one 40g bar) and more than 15% of their calories come from saturated fat.
A flurry of lawsuits quickly followed as plaintiff’s attorneys – who scour FDA warning letters for evidence of potential food labeling violations - accused KIND of violating consumer protection laws.
However, KIND’s petition – which you can read HERE – argues that the conditions of use for the term ‘healthy’ are outdated, reflecting a now defunct view that fat is the enemy.
KIND: Nutrient density is more important than low fat
The 2015 dietary guidelines advisory committee report does not recommend an upper limit for total fat and the FDA is itself proposing to ditch the ‘calories from fat’ requirement on the Nutrition Facts panel, because it is “not necessary to assist consumers in maintaining healthy dietary practices”.
However, food labeling regs still mandate that the term healthy can only be used as a nutrient content claim to describe foods that contain 3g or less total fat and 1g or less of saturated fat per serving, with the exception of fish and meat (which are subject to slightly different criteria), notes KIND.
In other words, said KIND founder and CEO Daniel Lubetzky, the regulations require that the majority of foods marketed as healthy must also meet the criteria for ‘low fat’ and ‘low saturated fat’ claims, “regardless of their nutrient density”, which means that fat-free puddings and sugary cereals can be labeled as ‘healthy’, while “nutrient-rich foods such as nuts, avocados, olives and salmon” cannot.
“The current regulatory framework prohibits the use of a “healthy” nutrient content claim on products that are nutrient dense, meet current federal dietary recommendations, and contain ingredients that Americans should be consuming.”
He added: “The current regulations were created with the best intentions when the available science supported dietary recommendations limiting total fat intake. However, current science tells us that the unsaturated fats in nutrient-dense foods like nuts, seeds and certain fish are beneficial to overall health.”
“Under FDA’s current application of food labeling regulations, whether or not a food can be labeled “healthy” is based on specific nutrient levels in the food rather than its overall nutrition quality. FDA formulated those regulations more than 20 years ago, when available science and federal dietary recommendations focused on limiting total fat intake. Today, these regulations still require that the majority of foods featuring a “healthy” nutrient content claim meet “low fat” and “low saturated fat” standards regardless of their nutrient density. This is despite the fact that current science no longer supports those standards.” KIND LLC
In its petition KIND urges the agency to amend the regulation for general nutritional claims in 21 C.F.R. 101.65(d)(2) such that producers wishing to use the term ‘healthy’ may exclude the total fat or saturated fat content contributed to the food in question by fruits, vegetables, nuts, seeds, legumes, whole grains, and seafood provided they are “used in their whole form or have been processed in such a way that did not materially degrade their nutritional value”.
It also notes that saturated fat is no longer considered to be the dietary bogeyman by some health experts, who point out that not all saturated fatty acids are the same and that recent meta-analyses of prospective observational studies have not found a significant association between higher saturated fat intake and risk of cardiovascular disease.
Penalizing a whole-food based product solely for being high in fat is problematic... Lumping all dietary fat into the same umbrella does not reflect the latest science. Andy Bellatti, MS, RD
It adds: “The health effects of saturated fat are not unitary. Whether or not any saturated fatty acids are actually health promoting, some are considered innocuous or nearly so. This conclusion, for instance, was reached about stearic acid by the 2010 DGAC, which advised that intake of saturated fat should be restricted, but that stearic acid should be exempted.
“Similarly, evidence is accumulating that lauric acid, a predominant saturated fatty acid in coconut oil, may also be innocuous.64 While further research in this area is needed, we note that recent meta-analyses concluded that the evidence did not clearly support cardiovascular guidelines recommending low consumption of total saturated fats.”
Health claims are not about health; they are about marketing. This petition is not about health; it is about marketing KIND bars...KIND wants to make health claims for its bars made with dried fruits, grains, and whole nuts. I see them as higher quality products than most of the bars on the market. But to claim that they are “healthy,” the company is caught in a Catch-22: If KIND bars are food products, FDA regulations don’t work for them. But if the FDA regulates KIND bars as foods, it only allows certain claims and these also don’t fit
Hence: the petition.
If FDA decides to take it seriously, I’m guessing it would have to go through a rulemaking process, which means publishing a notice of intent and asking for comments, dealing with the comments, publishing a proposed rule, dealing with more comments, and then issuing a final rule. Or it might start by asking the Institute of Medicine to do a study and make recommendations about how health claims could be improved. I hope the company is still in business by the time all that happens.
Dr Marion Nestle, professor of nutrition, food studies, and public health, New York University
KIND to FDA: Consumers are confused
Much of the petition, however, is devoted to a broader argument about the disconnect between the advice that Americans are given in the Dietary Guidelines and the criteria governing claims that manufacturers can make on pack.
According to KIND: “FDA’s current regulatory approach for food labeling claims limits the ability of food producers to tell consumers that products containing certain foods—such as nuts, whole grains, seafood, fruits, and vegetables— are healthy, even though they are currently recommended as key components of a healthful diet.”
Manufacturers should be allowed to make statements on pack (e.g. “Nuts are part of a healthy diet) that are consistent with federal dietary recommendations and current scientific evidence, argues KIND, which wants the FDA to initiate “rulemaking to define a ‘dietary guidance statement’ as a statement in food labeling about the usefulness of a food, or a category of foods, in maintaining healthy dietary practices.
“Specifically, KIND requests that this rulemaking explicitly allow for the use of claims in food labeling to communicate that certain foods are useful in creating a diet that is consistent with current dietary recommendations, and also that this rulemaking establish certain requirements, such as a meaningful amount requirement, to ensure that dietary guidance statements are not misleading.”
It appears that 2.5g of saturated fat in some nuts in a snack bar have triggered the beginnings of a major paradigm shift in food labeling.
Undoubtedly, present attention will simply focus on whether Bar X or Smoothie Y can legally use "healthy" on its label or not. The more forward-looking debate though will center around the definition and corresponding educational intent of "dietary guidance statements" and their corresponding "meaningful amount requirements" which when combined will better help consumers to choose foods that constitute an overall healthy dietary pattern.
Dr Rachel Cheatham, founder and CEO, Foodscape Group LLC