On March 12, 2019, snack bar producer, KIND, submitted a Citizen Petition to the FDA asking the agency to update the framework for regulating nutrient content claims (NCCs). In sum, the petition requests that FDA consider the overall quality of the food, rather than just the quantity of a certain nutrient when regulating nutritional claims on labeling. KIND argued that the NCC regulatory framework is outdated, does not reflect key principles of today’s evidence-based dietary guidance, and is ineffective in helping consumers make appropriate dietary choices.  Instead, KIND insisted the framework allows the use of NCCs that “mislead consumers to believe that the products bearing such claims provide useful evidence-based dietary value, when they do not.”

Through the Citizen Petition, KIND requested FDA take the following actions:

• “Revise its nutrient content claim regulations to only allow a food to bear a nutrient content claim highlighting the presence or absence of a nutrient if the food contains a meaningful amount of at least one health-promoting food, such as: vegetables, fruits (especially whole fruits), whole grains, legumes, nuts, and seeds, which are recommended in the most recent Dietary Guidelines of Americans.”

• “Amend 21 C.F.R. 101.13(h) to include disclosure levels for added sugar and trans fat and to remove disclosure levels for total fat and cholesterol.”

• “Revise its nutrient content claim regulations to disqualify foods, other than meal products or main dish products, that contribute more than 25 percent of the daily value for saturated fat, sodium, or added sugar or more than 1.0 gram of trans fat from bearing nutrient content claims.”

• “Revise its nutrient content claim regulations to require that, where a nutrient content claim is based on a nutrient that has been added to a food, such fortification is in accordance with FDA’s policy on fortification of foods in 21 C.F.R. 104.20.”

As stated, KIND argued the current framework allows for the use of claims based solely on the quantity of nutrients, without any consideration for the quality of the food.  KIND provided the following example in support: “[F]or most nutrients, a food can bear a “good source” or “excellent source” claim, regardless of whether the highlighted nutrient is naturally-occurring or was added through fortification, and regardless of whether the food is otherwise nutrient-dense. This means that a pack of gummy bears, fortified with inulin (a dietary fiber), could be labeled as a “good source of fiber” so long as the gummy bears contain about 3 grams of fiber – i.e., 10 percent of the daily value for fiber – per reference amount customarily consumed (RACC).”

Longtime readers may recall that this is not the first time KIND has petitioned FDA. In December 2015, KIND submitted a Citizen Petition that requested FDA reevaluate its NCC regulations with specific focus on those related to the term “healthy.” KIND argued that FDA’s “healthy” definition — which has remained the same since 1994 — is outdated and fails to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods. KIND submitted the Citizen Petition in response to an FDA Warning Letter, which requested the company remove the word “healthy” from its packaging. However, by May 2016, FDA reversed their decision and KIND was allowed to continue using “healthy” on its products.