The Food and Drug Administration has just announced that it will hold a Public Meeting on March 9, 2017 to discuss use of the term “healthy” in the labeling of human food products. The purpose of the meeting is to give interested persons an opportunity to provide input on use of the term “healthy” in food labeling and to provide recommendations to the Agency on whether any regulatory action is required to address this food labeling issue.
The meeting follows several recent steps by FDA to address this issue. On September 28, 2016, FDA published a Notice in the Federal Register inviting public comment on redefining the “healthy” nutrient content claim for food labeling. FDA requested that public comments be submitted to the docket by January 26, 2017. However, FDA has since extended the comment period to April 26, 2017. In addition, FDA also published a non-binding guidance in September 2016 entitled, “Use of the Term 'Healthy' in the Labeling of Human Food Products: Guidance to Industry.” The guidance advises food manufacturers of FDA's intent to exercise enforcement discretion with respect to the implied nutrient content claim “healthy” on foods that have a fat profile of predominantly mono and polyunsaturated fats, but do not meet the regulatory definition of “low fat,” or that contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.
In addition, FDA received a Citizen Petition from KIND LLC requesting the Agency update its nutrient content claim regulations to be consistent with current federal dietary guidance. In particular, the petitioners requested that FDA amend the regulation defining the nutrient content claim “healthy” with respect to total fat intake and amend the regulation to emphasize whole foods and dietary patterns rather than specific nutrients. KIND submitted the Citizen Petition to FDA after receiving a Warning Letter from the Agency in March 2015 objecting to the use of “healthy” claims make for KIND fruit and nut bars, which FDA noted did not meet nutrient content requirements for making such a claim.
The Public Meeting is scheduled to run a full day and include presentations by FDA and interested parties, breakout sessions, and an open comment and question and answer session. In part, FDA is inviting interested parties to provide information, share experiences, and raise issues specifically related to the nutrient content claim “healthy,” including (but not limited to): “healthy” as a nutrient-based claim, food component-based claim, or both; “healthy” single definition or definition by category; consumer understanding of and responses to the term “healthy”; and when, if ever, the use of the term “healthy” may be false or misleading. Interested parties may also submit electronic or written comments to the docket by April 26, 2017.
Though FDA has long establish nutrient content criteria for making a “healthy” food labeling claim, some food manufacturers have used the term “healthy” on food labeling to convey a positive perception of foods containing healthy ingredients – even though the food does not fully meet FDA’s nutrient content criteria for making such a claim. Thus, the Public Meeting and request for public comments are steps that will help FDA determine how to rein in the use of “healthy” claims not in full compliance with FDA requirements.