FDA Initiates Its "Healthy" Review of Nutrient Content Claims
On September 28, the U.S. Food and Drug Administration (FDA or the Agency) published a Request for Information regarding FDA's intent to update the standards for using "healthy" as an implied nutrient content claim in human food labeling. Importantly, the standards for making a "healthy" claim in food labeling have not been updated since 1993, when the Agency published its initial final rule on defining "healthy." FDA's recent efforts are intended to align the standards for the claim with science findings reflected in the 2015 Dietary Guidelines for Americans and relied upon by FDA in the final Nutrition Facts Panel and Serving Size rules. FDA's guidance also is intended to align closely with its 2016-2025 Foods and Veterinary Medicine (FVM) Program Strategic Plan.
The Agency's request for information specifically seeks stakeholder comments on proposed changes to the "healthy" nutrient content claim addressed in a citizen petition filed by KIND LLC. FDA also requests comments on a range of topics, including the food categories for which "healthy" can be used, nutrient criteria, the public health benefits of defining the term "healthy," and the costs to industry. Comments are due to FDA by January 6, 2017. The Agency also plans to host public forums to receive additional feedback from stakeholders, but FDA has yet to announce dates and locations.
In conjunction with the request for comment, the Agency released guidance for industry on how companies can use a "healthy" claim that complies with the current regulation while FDA is updating the rule. FDA has indicated that it may initiate enforcement if manufacturers fail to implement certain changes. For example, if a manufacturer uses the term "healthy" on the food label of a product not low in fat, then the amount of mono- and polyunsaturated fats must constitute the majority of the fat content. A manufacturer must also display the mono and polyunsaturated fat content on the label. If a manufacturer meets these requirements, then FDA intends to exercise enforcement discretion and permit the manufacturer to include "healthy" on its label.
Additionally, FDA may exercise enforcement discretion when manufacturers use the nutrient content claim of "healthy" on products that contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or Vitamin D, which are currently two nutrients of public health concern because of their general under-consumption by the U.S. population. For manufacturers who have not implemented the final rule on the Nutrition Facts Panel as it relates to the new DVs for potassium or Vitamin D, FDA will allow them to use the previous DVs for potassium and vitamin D. The Agency explains that its change reflects shifts in nutrient intake and the fact that vitamins A and C are no longer nutrients about which adequate intake is a concern.
As noted in our recent client advisory Key Conventional Food & Dietary Supplement Regulatory Developments That (May Have) Occurred While You Were on Summer Vacation, FDA is expected to evaluate other labeling claims as part of an effort to ensure that food labeling regulations are consistent with evolving scientific recommendations and the dietary needs of the current population. We will continue to monitor these developments and circulate updates, accordingly.
© Arnold & Porter Kaye Scholer LLP 2016 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.