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

Coral Beach January 10, 2017

Last year, Kind LLC filed a "citizen petition" with the Food and Drug Administration urging the agency to update their definition of healthy.

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 food​safe​tynews​.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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