FDA Slams Company for “Healthy” Label, Company Fights Back
[Posted on: Thursday, December 03, 2015]
In March of this year, FDA gave a Warning Letter to Kind LLC, the makers of Kind snack bars for use of the word “healthy” on the label of 4 of its products, among other things. FDA warned that the company does not meet the nutritional requirements defined in the law to legally call its products “healthy”. FDA objected to several other words used in the labels of Kind products such as “good”, the symbol “+”, and even the word “tasty”. Kind bars contain about 3 grams of saturated fats per serving compared to the 1 gram per serving required by the law for a food item to be called “healthy”. The main reason for the high fat content of Kind bars is the presence of high amounts of nuts which are naturally rich in saturated and monounsaturated fats, so while Kind bars contain natural food ingredients, there overall nutritional content is outside the boundaries established under the law. FDA enforces strict conditions for nutritional labeling. These rules that have in effect for more than 20 years are based on nutritional guidance from the late 1980s. It should be noted that the nutritional guidance are currently being revised by the Dietary Guidance Advisory Committee (DGAC). The new guidance is expected to be revised to allow high fat content due to addition of nuts and other natural food ingredients. The new nutritional guidance will be release by the end of this year. Meanwhile, upon getting the Warning Letter in March, the initial reaction of the company was to try to comply with the FDA instructions. Ideally it would have required either reformulating their bars to have less fat content, or simply removing the objected words from the labels. After 9 months of thinking, it seems the company decided that neither option is acceptable. Kind’s major marketing push has been the claim that their bars are healthy snacks as compared to unhealthy snacks that are known to high calorie, high fat, high sugar, and low in antioxidants; all issues that Kind bars claim to address. By changing the content or removing the label of “healthy” the company would likely lose its market advantage. So, now Kind has filed a citizen petition with FDA asking FDA to revise its definition of “healthy” to meet the soon to be announced new DGAC guidelines and exclude the fat content contributed by nuts and other natural ingredients from the calculation of total fat content of food. This is a tricky and bold move by Kind. Citizen Petitions are normally used for market approval of generic drugs under 505(q) process. While most citizen petitions must be responded to within 6 months of filing, FDA does not have to follow a strict timeline for general petitions like that by Kind. So, it could be some time before FDA responds. Also, FDA grants only about 19% of the citizen petitions, meaning it rejects more than 81% of the requests made via citizen petition process. Despite the odds, there are a couple of things that could work in Kind’s favor. First, the DGAC guidelines will soon be released and if they agree with Kind’s claims, FDA will have to justify rejecting it. It seems Kind timed its petition to the DGAC release. Second, Kind raised issues of “good fat” and other nutritional content that have general acceptance in nutritional science giving FDA a hard job to find arguments against them. Still the revised nutritional guidelines need to be incorporated into the CFR which takes time per the Rule Making process, so FDA may not decide quickly. Kind was probably picked because it was the fastest growing snack bar company 2 years in a row with sales of about 150 million units per year; so a delay in FDA’s decision would have a direct financial hit on the company. For now the company decided to stick to its guns. Meanwhile, over the last 9 months, the company did revise the labels of the bars that FDA warned against. So, the company is doing the smart thing which is to comply with FDA’s Warning Letter in the immediate period but fighting the ruling at the same time. All the best, Kind.
Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research