Healthy is a word that we use every day, but when we use it in terms of food labeling, the word takes on a more important and controversial meaning. In 2015, the FDA issued a warning letter to the KIND company stating that the use of the motto “healthy and tasty” on their nut based bars was inappropriate (see our article about that case here). KIND was stunned, as their bar is made solely of fruits and nuts.
In 1993, the FDA established that a food can be called “healthy” if it:
- Is low in total fat, saturated fat, or cholesterol
- Contains at least ten percent of the Daily Value of vitamin A, vitamin C, calcium, iron, protein, or fiber. [2]
However, this definition excludes foods like nuts, avocados, and certain fatty fishes that are considered healthy by nutritional guidelines. After the FDA issued a warning, KIND submitted a citizen’s petition requesting that FDA reevaluate their definition of healthy: “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.”[3]
This petition caused the FDA to consider updating its regulations on “healthy” claims. In the 2016 document “Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products,” the FDA recognized changes in the science of dietary guidelines. This guidance states their intent to exercise enforcement discretion when “healthy” claims appear on foods that are not low fat, provided that mono and polysaccharide fats comprise the majority of the fat content in the food and that the food labels declare the amounts of mono and polysaccharide fats. Also, since vitamins A and C are no longer considered to be vitamins of public health concern, FDA has decided to exercise enforcement discretion with foods that contain at least 10% of the DV of potassium or vitamin D, regardless of their vitamin A or C content.[4] The FDA has said that they will exercise enforcement discretion until they amend 21 CFR 101.65(d)(2). In September 2016, FDA issued a Federal Register notice requesting information and comments on the use of the term “healthy” in food labeling. As of April 2017, the FDA comment period closed and FDA began reviewing comments and developing a final rule to revise regulations surrounding the term “healthy.”
Food labeling on product packaging or company websites may have legal challenges that impact product importing and distributing in the U.S. Our team of experienced regulatory specialists and affiliated attorneys are available to answer your questions about healthy claims and other issues with your food labels. Contact us today.
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[1] CFR – Code of Federal Regulations Title 21, Sec. 101.62
[2] CFR – Code of Federal Regulations Title 21, Sec. 101.65
