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Saturday, December 7, 2019

What is 'healthy?' FDA to re-consider meaning of term

By Sean Fowler | May 25, 2016


SILVER SPRING, Md. (Legal Newsline) – The Food and Drug Administration (FDA) is re-evaluating the meaning of the term "healthy" for use on food labels.

"The big news (is) ... that (the) FDA plans to consider changes to the criteria for nutrient content claims, including 'healthy,'" Devon Winkles, an attorney with the firm Kelley Drye and Warren LLP, told Legal Newsine.

The impetus of this re-evaluation revolves around KIND, a granola bar manufacturer. The FDA requires that food items that have "healthy" on its label meet certain guidelines, including being low in saturated fat.

The KIND granola bars exceeded the amount of saturated fat required, and the FDA sent a warning letter instructing the company to remove the term.

It did so, and the FDA sent a closeout letter in April, ending the case. But following that, KIND sent a reply to the FDA asking if it would be acceptable for it to use the term in describing their company philosophy if it wasn't describing a particular item.

"With regard to KIND, FDA really just provided a clarification of its policy on using the term 'healthy' to describe the company’s ethos rather than the health attributes of a particular product," Winkles said.

The FDA approved the use of "healthy" in that context, since it is describing the company's ethos and not any particular food item. But it was the note at the end of its response that hinted at something far bigger - that the FDA will itself be re-considering the definition of the term "healthy."

Citing both nutrition research and a citizen petition from KIND, the FDA said that it is a good time to re-evaluate its regulations on nutrient content claims, and this includes the use of "healthy."

Winkles says that this small change could have a huge impact on the food industry at large. 

 "An ultimate change in the nutrient content claim rules could affect the entire industry, and FDA’s 'hint'  wasn’t limited to 'healthy' claims - it might be considering changing the criteria and approved uses for other nutrient content claims," she said.

The move is one that some have been asking the FDA to consider for some time.

"Generally, an item must be low in fat and low in saturated fat, and it can’t have too much cholesterol," Winkles said. "So some items we think of as being pretty healthy, such as eggs and nuts and full-fat yogurt, generally don’t qualify as 'healthy' under the current standard."

What happens next is unclear, as the FDA was vague about the process, which could take several years to be finalized. It did say that it will be seeking public comment on the situation. 

 "When it decides to formally begin the process, there will be a series of opportunities for stakeholders – including food companies, public health organizations and researchers, and consumers – to offer their views on what FDA should do," Winkles said.

"FDA said it would solicit public comments 'in the near future' but it wasn’t more specific. The rulemaking process can take years."

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U.S. Food and Drug Administration (FDA)