Rural America

Tuesday, Jan 10, 2017, 12:27 pm

FDA Grants Additional Time for Citizens (and Food Companies) to Define ‘Healthy’

By Coral Beach

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Last year, Kind LLC filed a "citizen petition" with the Food and Drug Administration urging the agency to update their definition of healthy.   (Image: fda.gov / kind llc)

Four months wasn’t long enough for some in the food industry to figure out how they want the FDA to define “healthy” for use on food labels, so the agency has extended the comment deadline on the topic for another three months.

The Food and Drug Administration’s deadline for public comments on the topic is now April 26, which is a month longer than at least one extension request sought.

The Grocery Manufacturers Association asked that the January 26 deadline be extended to March 26, citing year-end activities and holiday scheduling as part of the reason it needed more than four months to develop and submit comments.

Another food industry group, the United Egg Producers, was able to make the original deadline with its comments on what the word “healthy” means. Currently eggs cannot be labeled as “healthy” because of their cholesterol and saturated fat content. But the egg group, which says it represents producers of 95 percent of U.S. shell eggs, contends federal dietary guidelines support the “healthy” value of their product.

“Eggs are included in all three model diets outlined in the 2015-2020 Dietary Guidelines for Americans,” the egg group reminded FDA in its comments.

The United Egg Producers and the Grocery Manufacturers Association are just two of the more than 700 entities and individuals to file comments on the topic of “healthy” as of Thursday. The vast majority of comments appear to be from individuals, many of whom have suggested common sense definitions, such as “healthy should mean it’s good for your body.”

That’s the kind of definition FDA wants to make sure is not used. The agency wants to put a finer point on it, partly because of push back from the food industry on existing federal law concerning the use of the word “healthy” on food labels.

Who got this ball rolling?


In its initial September 2016 notice opening the comment period on the use of “healthy” on food labels, the FDA referenced that a “citizen petition” filed with the agency was part of the reason behind opening the discussion. What FDA did not explain in that notice was that the “citizen petition” was filed by granola bar maker KIND LLC of New York.

The 31-page petition from KIND, filed in December 2015, followed a March 2015 warning from FDA that challenged label language then used on several of KIND’s fruit and grain bars.

According to the FDA’s warning letter to KIND LLC:

”… the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims.” 

Specifically, FDA noted that four different flavors of KIND bars carried the word “healthy” on their labels in violation of federal law. The saturated fat content of the KIND bars ranged from double to four times the maximum amount allowed on foods that use the word “healthy” on labeling.

Thirteen months after sending the warning letter, the FDA sent KIND LLC a closeout letter in April 2016.

“Based on our evaluation, we conclude that you have satisfactorily addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections,” the FDA stated in the closeout letter.

While the “healthy” debate regarding those specific KIND bars appears to be ended, the process of redefining the word will likely take years.

In its petition seeking FDA’s review of the word, KIND LLC stated the current law is based on obsolete science and that FDA has applied it incorrectly.

According to the KIND petition:

 “FDA formulated those regulations more than 20 years ago, when available science and federal dietary recommendations focused on limiting total fat intake…”

Today, these regulations still require that the majority of foods featuring a ‘healthy’ nutrient content claim meet ‘low fat’ and ‘low saturated fat’ standards regardless of their nutrient density. This is despite the fact that current science no longer supports those standards…

… FDA has taken an overly broad approach that effectively prohibits the use of terms such as ‘healthy’ about certain foods that inherently do not meet FDA’s strict nutrient content claim requirements, even though ‘healthy’ claims could be readily used in a way that is not misleading to consumers.” 

The agency seemed to agree with some points in the KIND petition, stating in September 2016 that it was seeking comment on use of the word “healthy” as part of its efforts to update regulations.

“This action is consistent with our recently released 2016-2025 Foods and Veterinary Medicine Program’s strategic plan with specific goals for nutrition and other planned and recent activity including the issuance of final rules updating certain of our nutrition labeling regulations,” FDA’s September notice stated.

“We invite public comment on the term ‘healthy,’ generally, and as a nutrient content claim in the context of food labeling and on specific questions contained in this (notice).”

How to file comments

To submit comments via the Internet, click here. Comments submitted online will be posted for public viewing.

For directions on how to submit confidential comments, click here. Confidential comments cannot be submitted online.

To submit comments by mail, hand delivery or courier, use this address:

Division of Dockets Management (HFA-305),

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

All comments must include the Docket No. FDA-2016-D-2335.

 

"FDA allows more time for comments on ‘healthy’ food labels" was orginially published on foodsafetynews.com and is reposted on Rural America In These Times with permission from the author.

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Coral Beach is a print journalist with more than 30 years experience as a reporter and editor for daily newspapers and trade publications including the Kansas City Star, the Independence Examiner and the St. Joseph News-Press & Gazette. A Jayhawk by birth and education, Beach earned a bachelor’s of science in journalism from the University of Kansas. She enjoys playing trumpet in a community concert band and shares her childhood home in Kansas City with her sister Sandy Beach.

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