Although “healthy” might sound like a subjective term, FDA has long-defined “healthy” under nutrient content claim regulations. For example, to be “healthy” an item must be low in fat and saturated fat.  Many stakeholders and health advocates have argued that this conception of “healthy” may be outdated, and the agency hinted this week that it will be re-considering the criteria for “healthy” and similar claims.

In March 2015, KIND, the makers of granola bars, received a warning letter from FDA in part because it labeled certain products as “healthy” even though the products contained more saturated fat than is permitted for a “healthy” claim.  KIND changed its labeling, and FDA issued a closeout letter in April 2016.   Soon after, KIND requested that FDA confirm it could use “healthy” to describe the company’s corporate philosophy.  FDA agreed that using “healthy” in that way is acceptable, because it is not used as a nutrient content claim and does not appear on the same display panel as nutrient content claims or nutrition information.

FDA issued a statement explaining its analysis of the “healthy” claim for KIND’s corporate philosophy and in that statement, it also announced that “now is an opportune time to reevaluate regulations concerning nutrient content claims, generally, including the term ‘healthy.’” FDA cited evolving nutrition research, forthcoming Nutrition Facts labeling final rules, and a citizen petition from KIND for this decision.

FDA plans to solicit public comments on these issues “in the near future.” Through the comment process, companies and organizations with views on the appropriate criteria for “healthy” and other nutrient content claims can help educate FDA and ultimately shape FDA policy.  Stakeholders should begin considering their opinions now, to be able to respond when FDA opens its comment period.

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