tran sfatlitigation update - khlaw.com litigation webinar (10-8-15).pdf · tran sfatlitigation...

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Tran s Fat Litigation UpdateOctob er8, 20 1 5

Ev an gelia Pelon is, Coun selCh ristoph erVan Gun dy, Partn er

Douglas J. Beh r, Partn er


Trans Fat in Nutrition Labeling

Tran s fat b ecam e a m an datoryelem en tofn utrition lab elin g in 20 0 3, effectiv eJan uary1 , 20 0 6

Respon se topetition from CSPIan d topub lish ed h um an studies lin k in g tran s fattoin crease in low den sitylipoprotein -ch olesterol (LDL-C) ("b ad ch olesterol") inth e b lood, w h ich in creases th e risk ofdev elopin g coron aryh eart disease(CHD)


Trans Fat in Nutrition Labeling

Tran s fat declared in gram s perserv in gton earest 0 .5-gram in crem en t b elow 5gram s an d ton earest gram ab ov e 5gram s

< 0 .5 g = 0 g trans fat

N oDailyValue

N odefin ed N utrien t Con ten t Claim s suchas “tran s fat free” or“low in tran s fat”


FDA’s Final Determination on PHOs

Partiallyh ydrogen ated oils (PHOs) areth e m ajordietarysource ofin dustrially-produced tran s fat in processed foods

FDA h as determ in ed th at PHOs are n olon gerGRAS (gen erallyrecogn ized assafe) torem ov e artificial tran s fat fromth e food supply

Goal:reduce CHD an d prev en t h eartattack s



Ten tativ e Determ in ation :N ov em b er8, 20 1 3 (See 78 FR 671 69)

Fin al Determ in ation :Jun e 1 7, 20 1 5 (80 FR 34650 )

PHOs are n ot GRAS un deran ycon dition s ofuse in h um an food

PHOs w ill b e con sidered food additiv esth at require pre-m ark et approv al



N olon gercon sen sus am on g qualifiedexperts tosupport th e safetyofPHOs inh um an food

Ifscien tific in form ation m aterializes afterGRAS con clusion reach ed, con clusionsh ould b e reassessed an d GRASposition rev ersed, w h ere n ecessary;b uth ere, som e w ould argue th at datach allen gin g GRAS position is w eak



FDA position on PHOs is un ique

21 CFR 1 70 .38 giv es FDA legal auth oritytopub lish n otice (declaratoryorder)w h en it determ in es a sub stan ce is n otGRAS – rulem ak in g n ot n ecessary



Com plian ce date Jun e 1 8, 20 1 8 – PHOsw ill b e con sidered food additiv e

FDA h as declin ed toelab orate on th elegal status ofPHOs durin g th is 3-yearperiod

Th ree years togiv e in dustry• tim e torem ov e PHOs an d

• opportun itytosub m it FAPs orFCN s tocov erlow lev el uses ofPHOs

SelfGRAS n olon geran option



GM A h as sub m itted a FAP fora v arietyoflow lev el application s

Exam ples ofproposed uses:

• Coloran d flav orcarriers

• Deliv ertextural ch aracteristics th at oth eroilscan n ot prov ide (e.g., flak in ess in dough s)

• Processin g aid (e.g., pan release agen ts)

On Octob er1 , GM A an n oun ced th at FDAh as accepted th e FAP forfilin g

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Some Products That Have Been Sued


Important Dates

N ov em b er8, 20 1 3

– FDA’s Prelim in aryDeterm in ationth at PHOs are n ot GRAS

Jun e 1 8, 20 1 5

– FDA’s Fin al Determ in ation


Trans Fat Litigation Cases

1 9 Cases Hav e Been Filed

Earliest Case W as 20 0 6

Latest W as Jun e 1 8, 20 1 5

Som e Cases Stayed

Som e Cases Settled

Som e Com plain ts Dism issed

N oTrials

N oAppellate Rulin gs


Primary Allegation about Trans-Fats

Accordin g toPlain tiffs:

Tran s fats are N OT SAFE


Primary Allegation - 2:

Accordin g toPlain tiffs:

Th ere are n osafe lev els ofin tak e

It h as b een b an n ed b yAm erican statesan d gov ern m en ts ab road


Primary Allegation - 3

It causes:

• CHD (coron aryh eart disease)

• Type-2 Diab etes

• Breast Can cer

• Prostate Can cer

• Colorectal Can cer

• A lzh eim er’s Disease an d Cogn itiv e Declin e


Causes of Action

Californ ia Con sum erLegal Rem edies Act

Californ ia Un fairCom petition Act

Californ ia False Adv ertisin g Law

• A ll require sh ow in g of“lik elih ood ofdeception ofa sub stan tial n um b erofcon sum ers”

• Four-yearstatute oflim itation

• Dam ages, in jun ctiv e relief(lab el ch an ge)

• Attorn eys’Fees?


Causes of Action

Un fairCom petition Act (“Section 1 720 0 ”)• “Un law ful”

– Predicate acts ofv iolation s ofoth erlaw s

– FDCA

– Californ ia’s Sh erm an Law

• “Un fair”– Cost/b en efit

– Pub lic policy

• “Fraudulen t”– M isrepresen tation s

– Om ission s


Possible Claims

M isleadin g Con sum ers

• E.g. “0 g Tran s Fat”

N on -Com plian ce w ith FDA Regulation s

• “Tran s Fat Free”

Un safe/h arm ful toCon sum er

• “Lin earrelation sh ip” b etw een PHO an d CHD

• Fin al Determ in ation


Historical Claims

In itial claim s focused on th e allegationth at tran s fats are h arm ful:

(1 ) such practice w as “un fair” w ith in th em ean in g ofth e Californ ia Un fairCom petition Lawb ecause th e con duct is im m oral, un eth ical,un scrupulous, orsub stan tiallyin jurious tocon sum ers, an d th e utilityofth e con duct, ifan y,does n ot outw eigh th e grav ityofth e h arm toDefen dan ts’v ictim s.

Simpson v. California Pizza Kitchen


Historical Claims - 2

(2) th at Defen dan ts’practices v iolate pub licpolicy;an d

(3) Defen dan ts’action s alsov iolate pub licpolicyb ycausin g th e Un ited States, Californ ia,an d ev eryoth erstate topay— v ia M edicare,M edicaid, Veteran s Health Adm in istration an doth erprogram s— fortreatm en t oftran s fat-relatedilln esses

Simpson v California Pizza Kitchen


Label Claims That Have Been Attacked

“Heart Health y” on a b reak fast productallegedlycon tain in g tran s-fats

– Actual Claim : “Heart Health yW h ole Grain s”

“Part ofa delicious h eart h ealth yb reak fast”

“W h olesom e,” “quality,” “goodn ess inev eryb ow l”

Guttmann v. The Quaker Oats Co.


Newer Claims

Violation ofFederal an d State Lab elin gLaw s

“N oTran s Fat” w ith out listin gpolyun saturated an d m on oun saturatedfattyacids on th e lab el in allegedv iolation of21 C.F.R. 1 0 1 .9(c) (2) (iii) an d(iv )

Kaufer v. KIND, LLC (April 1 7, 20 1 5)


Newer Claims

“0 g Tran s Fat”• “M isleadin g”

– M isrepresen tation /Fraudulen t

• Oth erClaim s– Plain tiffs claim th is is an un auth orized n utrien t

con ten t claim

– Plain tiffs claim th is v iolated state law relatin g toch aracteristics an d stan dards

– Plain tiffs claim th is is a w arran ty

Backus v. H.J. Heinz (Jun e 1 8, 20 1 5)


Newer Claims

“N oTran s Fat” an d “All N atural”

• “M isb ran ded”– Illegal tosell orpossess

• “Fraudulen t”– Deceptiv e

Smedt v. The Hain Celestial Group, Inc. (July1 4, 20 1 4)


Newer Claims

“0 g Tran s Fat (on fron t lab el)• Sh ould n ot m ak e or• Sh ould referton utrition in form ation pan el

M an datoryDisclosure Requirem en ts• Californ ia m an datorydisclosure requirem en ts b ased on federal law• 21 C.F.R. Section 1 0 1 .1 3(h )• Requires disclosure offats an d ch olesterol, i.e., are m aterial to

con sum ers:Ifa food … con tain s m ore th an 1 3.0 g offat, 4.0 g ofsaturated fat, 60m illigram s (m g) ofch olesterol, or480 m g ofsodium perreferen ce am oun tcustom arilycon sum ed, perlab eled serv in g, or, fora food w ith a referen ceam oun t custom arilycon sum ed of30 g orless … per50 g… th en th at foodm ust b eara statem en t disclosin g th at th e n utrien t exceedin g th e specifiedlev el is presen t in th e food as follow s:“See n utrition in form ation for_ _con ten t” w ith th e b lan k filled in w ith th e iden tityofth e n utrien t exceedin g th especified lev el, e.g., “See n utrition in form ation forfat con ten t.”

Bishop v. 7-Eleven – Briefon Appeal


Court Rulings

“N oTran s Fat” is OK• Plain tiffargued th at th e claim w as

m isleadin g b ecause th e product w as n ottran s fat free

• Court ofAppeals ruled th e claim w as n otm isleadin g b ecause FDA regulation sallow ed sim ilarstatem en ts b ased on anin div idual serv in g an d th e in div idual serv in gw as properlylab eled 0 g tran s fat.

Young v. Johnson & Johnson, N o. 1 2-2475, 3d Cir. 20 1 3


Court Rulings - 2

“N oTran s Fats” is N OT OK

• FDA w arn in g letters h av e stated th at “N oTran s Fat” is “an un auth orized n utrien tcon ten t claim . . . w h ich h as n ot b eendefin ed b yFDA”

• Th e Court w ill defertoFDA’s in terpretation

Reid v. Johnson & Johnson,N o. 1 2-56726 (9th Cir. 20 1 5)


Current Issues – cont’d

Can foods w ith PHOs b e law fullysold?

• On e Court cited FDA’s action in settin g th ecom plian ce date forth ree years in ordertoallow th e in dustrytouse its curren t in v en toryas in dicatin g “th at it w as n ot an d is n otun law ful un derfederal law tosell th emb efore th at tim e”

Backus v. General Mills, Inc., N o1 5-cv -0 1 964(N .D. Cal. Aug. 8, 20 1 5)


Current Issues – cont’d

Can foods w ith PHOs b e law fullysold?• Th e sam e Court cited FDA’s action as

estab lish in g th at sellin g foods w ith PHOsm ayb e illegal un derCaliforn ia’s Sh erm anAct

• Th e Court alsoruled th at it m ayb e “un fair”un derCaliforn ia law tosell foods w ith tran sfats



Primary Jurisdiction

• Courts h av e stayed pen din g tran s fat casesun derth e prim aryjurisdiction doctrin eaw aitin g FDA’s determ in ation w h eth ersm allam oun ts oftran s fats can law fullyb e usedas a food additiv e



Other Issues

Can you claim th at a food w ith tran s fatsis “n utritious”?


Pending Cases

Bishop v. 7-Eleven – b efore th e N in thCircuit Court ofAppeals

K IN D BarLitigation – South ern District ofN ew York

Smedt v. The Hain Celestial Group


W ash in gton ,DC • Brussels • San Fran cisco• Sh an gh ai• Paris

K elleran d Heck m an LLP

THANK YOUEv e Pelon is

Coun selW ash in gton , DC Office

+ 1 20 2.434.41 0 6pelon is@ k h law.com

Ch ristoph erVan Gun dyPartn er

San Fran ciscoOffice+ 1 41 5.948.2831

v an gun dy@ k h law.com

Douglas J. Beh rPartn er

W ash in gton , DC Office+ 1 20 2.434.421 3b eh r@ k h law.com

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