Today, FDA announced a public meeting to give interested persons an opportunity to discuss the use of the term “healthy” in the labeling of human food.

  • As previously covered on this blog,  on September 28, 2016, FDA published a request for comment in the Federal Register.  The comment period, which was originally scheduled to end on January 26, 2017, was later extended to April 26, 2017.  At the same time, FDA published a guidance for industry entitled “Use of the Term ‘Healthy’ in the Labeling of Human Food Products,” in which the Agency stated their 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. FDA has received over 800 comments in response to its request, and on January 27, 2017, FDA received a Citizen Petition from the Union of Concerned Scientists urging the FDA to establish “disqualifying levels” of added sugars that would render a product ineligible to use labeling or advertising with “healthy” claims.
  • FDA could promulgate regulations to formalize its current enforcement strategy as is or with amendments, including, potentially, establishing a “disqualifying level” for added sugars as part of its possible redefinition of the term “healthy”. The public meeting, which will be held in Rockville, Maryland on March 9, 2017, will offer an opportunity for interested parties to weigh in on these issues and others relating to the use of the term “healthy” in the labeling of human food.
  • The meeting will include introductory presentations, perspectives panels, and multiple opportunities for individuals to express their opinions at the meeting through oral presentations, participation in breakout sessions, and submission of electronic or written comments. FDA remains particularly interested in information, experiences, and issues related to:
    • “healthy” as a nutrient-based claim, food component-based claim, or both;
    • “healthy” single definition or definition by category;
    • consumer understanding of and response to the term “healthy”; and
    • when, if ever, the use of the term “healthy” may be false or misleading.
  • K&H will continue to closely monitor developments in this area. Clients who are interested in submitting written comments or in receiving a summary of the public meeting are invited to contact Melvin Drozen at or 202-434-4222.