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FDA Requests Public Comment on “Healthy”

On September 28, 2016, the U.S. Food and Drug Administration (FDA) opened the term “healthy” to public comment through a “request for information.”  The agency’s goal is to promote the development of healthier foods and to assist consumers in making food choices that are consistent with current public health recommendations.  Food manufactures may continue using the term “healthy” as long as they meet the current regulatory guidelines during the comment period.

Examples of questions FDA hopes to have answered during the comment period include “What should healthy mean from a nutrition perspective?” and “How do consumers view the word healthy?” Interested parties can find information for submitting written and electronic comments here.  In addition to allowing industry to submit written comments, FDA plans to host public forums to receive further feedback.

FDA’s request for information on the term was sparked in part by a citizen petition filed by KIND LLC in December 2015 after receiving a warning letter for using the term “healthy” on some of its product labels. In its petition, KIND urged FDA to update its definition of “healthy” to be consistent with evolving information on overall nutrition quality rather than specific nutrient levels.  For example, foods like almonds, avocados, and salmon are too high in fat to meet FDA’s current regulations for “healthy,” but are recognized as having a valuable place in a healthy diet.

Until FDA lands on a final definition for “healthy,” the agency is using enforcement discretion to allow certain foods that don’t meet the agency’s current requirements to bear the content claim “healthy.” According to a guidance document recently published by FDA, it has no intention to “enforce the regulatory requirements for products that use the term if certain criteria described in the guidance document are met.”  The criteria outlined in the guidance document apply to foods that:

  • Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or
  • Contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

Registrar Corp stays up-to-date on U.S. FDA food labeling regulations and will continue to update industry as FDA’s decision on redefining “healthy” unfolds.  Please feel free to contact us with any questions regarding U.S. FDA requirements for using certain claims or other FDA labeling regulations, including the recently finalized changes to the Nutrition Facts Chart.  You can reach Registrar Corp by phone at +1-757-224-0177 or our Regulatory Advisors are available 24-hours a day online at www.registrarcorp.com/livehelp.