Last December, we discussed how the snack bar company, Kind LLC, was first
slammed by FDA for using “healthy” on its label and its fight to convince FDA to use current nutritional standards. This week, FDA reversed its decision and allowed the company to use “healthy” label on its packaging in relation to its “corporate philosophy,” not as a nutrient claim. This is a great example of escalating an issue when FDA over-extends its interpretation of the mandate and regulatory intent. Some background, in March 2015, FDA gave a Warning Letter to Kind for use of the word “healthy” on the label of 4 of its products, among other things. FDA warned that the company did 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. Initially, upon getting the Warning Letter, Kind tried to comply with the FDA instructions but after 9 months of reconsidering trying to reformulate and failing to manufacture a product that would meet FDA’s requirement, Kind filed a citizen petition in December 2015 asking FDA to revise its definition of “healthy” to meet current standards. This week, FDA finally responded positively to Kind. Good job, Kind!
Company Wins “Healthy” Label from FDA
Author

Dr. Mukesh Kumar
Founder & CEO, FDAMap
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