FI L ED U.S. COURT OF A P P E A LS E LE V E N T H C IR C U IT OCT 7, 2008 THOMAS K. KAH

N CL ERK [PUBLIS H] IN THE UN ITED STATES COURT OF APPEALS FO R T HE EL EV EN TH CIRC UI T

____ ____ ____ ____ ____ ____ N o. 07- 1430 9

____ ____ ____ ____ ____ ____ D. C. Docket N os. 05-0208 3 CV- GE T- 1

06 -0 04 06 -CV-GET HI-TECH PHARMAC EUTICALS, INC., Pl ai nti ff -Appe llant,
ve rs us LESTER M. CRAWFORD, D. V.M., Ph.D., as Co m m iss ion er of the U nit ed

S ta te s F ood an d D ru g A dm ini str at ion , UNITED STAT ES FOOD AND D RUG ADMINISTRATION, MI CH A E L O
. L E A V IT T , a s S ec re tary of the D ep ar tm en t of H ea ltha nd H um anS er

vic es , UN IT ED ST AT ES DE PA RT MEN T O F H EA LT H A ND HU MANSE RVI CE S, ACTING COMM ISSI ONER ANDREW C. VON ESCHENBACH, M.D.,

D ef en dants -Appe lle es .

____ ____ ____ ____ ____ ____ N o. 07- 1431 2

____ ____ ____ ____ ____ ____ D. C. Docket N os. 06-0040 6 CV- GE T- 1

05 -0 20 83 -CV-GET2

UNITED STAT ES OF AMERIC A, Plaintiff-T hird Party De fendant-Appellee,
ve rs us 18 CASES, MORE OR LESS, OF AN ARTICLE OF FO O D , E A CH CA SE CO N T A IN IN G 120 /10 0 TA BL ET BO TT LE S L ABE LE D IN P ART L ipo dr en e D ie tary

S uppl em en t 10 0 c t. Si daCo rd if

oli a (l eave s) ( 25 m g e phe dr ine gr oup al ka loi ds) L ot 0 5121 004 Manuf ac tur ed f or Hi-Tec h P ha rm aceu ti cal s, In c., Norc ro ss , GA, et al ., D ef en dants , HI-TECH PHARMAC EUTICALS, INC., Cl ai m an t- T hir d P ar

ty P la int if f- Appe llant.

____ ____ ____ ____ ____ ____ Appeals fr om

the United State s District Court fo r the N orthe rnD istri ct

of G eo rg ia

____ ____ ____ ____ ____ ____ (O ct ob er 7, 200 8) Be fo re W IL SO N , P RY O R and C O X , Ci rc uit Jud ge s. PE R CU RIA M: W e co nsi de r in this ap pe al w he the r 21 U
. S. C. § 34 2( f) (1 )’ s de nov o pr ovi sio n im pa ct s t he ev id en ti ary weig ht to be gi ve n t o F oo d a nd Drug Adm in is tra ti on (FDA) regulations. Section 342(f)(1)’ s de novo provisi on provides that a review ing court3

sha ll de ci de a ny iss ue in an ad ult er at ed die tary supp le m en t proc ee din g de nov o. T he iss ue is w he the r a FD A r eg ula tio n w hic h de cl ar es that di et ar y sup ple m en t s c ont ai nin g ephedrine alkaloids are adulterat ed i s sufficient proof of adulteration, or is m ore
ev ide nc e ne ed ed

und er § 342( f) (1 )’ s de novo pro vis ion ? Be ca use F D A r eg ula tio ns ha ve the f

o r c e a n de f

f e c to f l a w , w e c o n c l u d e t h a tt h e n o o t h e r e v i d e n c e i s n e e d e d. We a f f i rm. I. BACKGROUND H i- T ec h P harm ac eu tic al s, I nc . m anuf ac tur ed , m ar

ke te d, dis tr ibu te d, a nd s old dietary suppl em ents containin g ephedrine alkaloids. In June 1997, the United States FD A p ro po sed ar

ule r eg ar din g pr oduc ts c ont ai nin g c er ta in l ev el s of

e phe dr ine al ka loi ds. T he F D A r ecei ve d tho usands of c om m en ts and c onsi de re d vo lum ino us
ev ide nc e ab out the ri sks of e phe dr ine a lka loi ds. T he n, six a nd a ha lf y ears la te r, in Fe br uary 200 4, the F D A is sued the “ Fi na l R ule D ec lari ng D ie tary

S uppl em en ts Co nta ini ng E phe dr ine A lka loi ds A dul te rate d B ec au se T he y Pr es en t an U nr ea sona ble Ri sk” ( the “ Fi na l R

ule ”)
. T he F ina l R

ule state s: Dietary suppl em ents containin g ephedrine alkalo i ds present an unr ea sona

ble r isk of il lne ss o r in

jury und er c ondi tio ns o f use recom m ended or sugg ested in the labeling, or if no conditio ns of use are re co m m en de d or sugg es te d in the la be lin g, und er

or din ar y c ondi tio ns o f use. T herefor e, dietary supp lem ents c ontaini ng e phedrine a lkaloid s are4

ad ult er at ed und er se ct io n 40 2(f

)( 1) (A ) of the F ed er al F ood, D ru g, a nd Co sm et ic A ct . 21 C
. F. R. 119
. 1. T he F ina l R

ule w as e na ct ed

und er the D ie tary

S uppl em en t H ea lthE duc at ion A ct of 199 4 ( D SH E A ), P ub. L
. N o. 103-4 17 , 108 S ta t. 432 5 ( 1994 ), a m en din g th e Fe de ra l F ood, D ru g, a nd C osm et ic A ct (F D CA ), 21 U
. S. C. § 30 1- 399. U nde r the FD CA , “ ad

ult er at ed ” de sc ri be s a pr oduc t tha t “ pr es en ts a sig nif ic an t or unr ea sona

ble ri sk o f illne ss o r inj ur

y und er c ondi tio ns o f use r ec om m en de d or

sug ge ste d in l ab el i n g ,” o r i f t h e l ab el i n g d o es n o t d i s cu s s i t , “ u n d er o rd i n ar y co n d i t i o n s o f u s e[ .]” 21 U.S.C. § 3 42 (f)(1 )(A). T he F ina l R

ule be cam e ef

fe ct ive on A

pr il 12, 200 4. I ts e ff

ec t w as to b anthe
sa le a nd d istri but ionof

a ll die tary su pp lem en ts c ont ai nin g e phe dr ine a lka loi ds and to m ak e th os e pr od uc ts su bjec t to se iz ur e an d con de m na ti on by th e g ov ern m en t. On February 23, 2006, United State s Marshals entered H i-T ech’ s prem ises and s ei zed
som e dietary

suppl em ent products an d i n gredients found there. H i-T ech concedes tha t the se iz ed

pr oduc ts and i ngr ed ie nts c ont ai n e phe dr ine a lka loi ds.

II. PRO CE DU RAL HI ST ORY Pr ior to the se iz ur e, H i- T ec h fil ed a dec larator y re lie f ac tio n see kin g r el ie f fr om
en fo rc em en t of

the F ina l R

ule on the gr ound

that the F D A ha d not com pli ed w iththe5

Adm inistrative Pro ce d u res A ct (A PA ) in prom ulgatin g the Final Rule (“ the AP A action”). T he United Sta t es fi led a separa te action for f orfeiture of dietary supp le m en t pr oduc ts and i ngr ed ie nts c ont ai nin g e phe dr ine alka loi ds ( “ the
en fo rc em en t a ct ion ”)
. A ft er the pr ope rty

w as se iz ed , H i- T ec h f

ile d astate m en t of int e r e st a nd at hi r d- part y

c om pl a i nt i n t he e nf

or c e m e nt a c t i on . T he d i str i c tc ourt
co nsol ida te d th e A PAa ct iona nd the e nf or ce m en t a ct ion
. On cr o s s -mot i o n s fo r su m m ar y ju d g m en t , th e d i s t ri ct co u rt d en i ed Hi -T ec h ’s
m otion and granted summ ary j udgm ent to the FD A and the United States, finding th at all required adm inistrative procedures we re f ollowed and that the seizure w as proper be cau se th e se iz edpro pe rty was adul te rat ed
. Se e H i- Te ch Pharm

. , I

nc . v . Craw

ford , 505 F. S upp. 2d 1 341 (N
. D
. G a. 200 7)
. H i- te chappe al s. III. STANDARD OF REVIEW T his c ourt r ev ie w s adis tr ic t c ourt’ s gr an t of sum m ar y j udgm ent de nov o,
a p p l yi n g th e sa m e le ga l s ta nd ard s u se d b y th e d is tri ctco ur t. Se e, e . g. , Hilburn v. Murata Elecs. N. Am ., Inc. , 181 F. 3d 1 2 20, 1225 (11t h Cir. 1999 ). Sum m ary j udgm en t i s ap pr opr ia te w he re “ ‘ the re is no ge nui ne iss ue as to any m at er ia l f

ac t and the m ovin g party

is entitled to a jud g m en t as a m atter of law. ’ ” W oode n v . B d. ofHi-Tec h’s other a rguments on appea l are meritless. Hi-Tec h contends that: (1) duringthe 1 administrative proc ess, the F DA did not provi d e adequate notice that the Final Rule mig ht ban ephedr ine alkaloids complete ly ; (2) the F inal Rule is not a logica l outgr owth o f t h e re g ulation ori gi n al l y proposed by

the FD A; and (3) the FD A’s use of a risk-be nefit ana ly sis to determine whether a dietar y supplement poses an “ unrea sonable risk” is contrar y to cong ressional int ent and unre a so na

ble its e lf . We fi nd the se argume nts me ri tle ss fo r the re a so ns state d b y the dis tr ic t c ourt . See H i-Tech Pharm. , 505 F. Supp. 2d at 1351-1353. 6 R eg en ts o f the U niv
. Sy s. of G a. , 247 F. 3d 1262 , 1271 (1 1th Ci r. 2001 ) (quot ing F ed
. R. Civ. P . 56(c) ). IV. ISSUE ON APPEAL H i- T ec h r ai se s se ve ra l i ssu es on app ea l, but onl y one m er its dis cu ssi on. H i- 1 Te ch contends th at the district court err oneous ly relied on the Final Rule to find that H i- T ec h’ s di et ar

y sup ple m en ts w er e adu lte rate d and, the re fo re , pr ope rl y se iz ed
. H iT ec h arg ue s th at , in ane nf or ce m en t pr oc ee din g un de r the statut e, the G over nm en t
m ay not r el y on the F ina l R

ule to m eet it s bu rdento pr ove that a pr oduc t i s adulterated. The Governm ent m ust ins t ead, Hi-T ech ar gues, present additional
ev ide nc e to the dis tr ic t c ourt t o pr ove , by a pr ep onde ranc e of the e vid en ce , that the pr od uc t i s ad ul te rat ed
. In m ak in g t hi s ar gu m en t, Hi -Tech rel ie s o n t he lan gu ag e o f 21 U.S.C. § 342( f) (1 ), w hic h st at es the co ndi tio ns unde r w hic h a diet ar y supp le m en t or i ngr ed ie nt shall be deem ed to be adulterated. In t his case, the Governm ent relied on 21 U. S. C. § 34 2( f) (1 )( A ), w hic h st at es that a die tary sup ple m en t w ill be de em ed a dul te rate d if7

it “ pr es en ts a

sig nif ic an t or unr ea sona

ble ri sk o f ill ne ss o r inj ur

y und er . . . c ondi tio ns of use rec omm ended or sugg ested in labeling , o r . . . i f n o conditio ns of use are sugg ested or recomm ended in the labeling, under ordinary conditi ons of use[. ] ” Id

. L at er , the statut e tha t a

ppl ie s to e nf

or ce m en t pr oc ee din gs s ta te s, “ Ina ny pr oc ee din g unde r [2 1 U
. S. C. § 34 2( f) (1 )], the U nit ed S ta te s sh al l be ar

the bur de n of

pr oof on
ea che le m en t t o sh owthat a di et ar y sup ple m en t i s a dul te rate d. T he c ourt sh al l de ci de any issue und er this paragra

ph on a de novo basis.” 21 U. S. C. § 342 (f) (1). H i- T ec h f

oc use s onthe use of

the te rm de nov o inthe la st s en te nc e of 21 U. S. C. § 342(f)(1) and argues that it requires a district c ourt to hear original eviden ce on the que sti on o f ad

ult er at ion , e ve n w he re the FD A ha s c ondu ct ed a n a dm ini str at ive
ru le m ak ing pr oc es s and p ro m ulg at ed a va lid ru le de cl ar ing the pr oduc t a dul te rate d. V. DISCUSSION As a genera l m a t t e r , F D A r e gu l a t i on s l i ke t he F i na l R ul e , w hi c h have b e en is su edaft er p ro pe r ad m in is tra ti ve p r o c es s, h av e th e fo rce a nd effe ctof l aw. See Abbott Labs v. G ardn er , 387 U
. S. 136 , 151 -5 3, 87 S
. Ct. 1 50 7, 151 7- 18 ( 1967 ) (s ta tin g th at

af ina l F D A r eg ula tio n, if

w ith in the a ge nc y ’ s auth or ity , ha s th e status of law) . I t is for this reason that viol ation of such re gulatio ns m ay “ carr y heavy crim inal
an d c iv il san ct io ns ,” su ch as f or fei tu re. 3 87 U.S. at 1 52 , 87 S. Ct. at 15 17
.Se e NVE , I nc . v . D e p’ t of He alt h a nd Hu ma n S

e rv s. , 436 F.3d 18 2 , 1 9 2 (3 dCir. 2006); 2 Nutraceutical Corp. v. Von Esche nbach , 459 F.3d 1033, 1037 ( 10th Cir. 2006). 8 T he que sti on p ose d inthi s a ppe al is w he the r the de novo langua ge in the la st
se nte nc e of

21 U
. S. C. § 34 2( f) (1 ) som eh ow tr an sf orm s the Fi na l Rul e int o so m ethin g oth er than ar eg ula tio n w iththe f or ce of law . I n othe r w or ds, did Co ngr es s a ct

to dim ini sh the ef

fe ct of the FD A re gul at ion s re gard ing ad ult er at ed die tary sup ple m en ts by using the term

de novo in the last sentence of the statute? A s th e part ie s r ec ogni ze , the m eanin g of the de nov o la ng ua ge in the la st
se nte nc e of

21 U
. S. C. § 34 2( f) (1 ) in an en for ce m en t a ct ionis aniss ue of f ir st im pr es sio n inthe f

ed er al ap pe llate co urts. T w o c ourts o f ap pe al s have he ld tha t the pr ovi sio n a

ppl ie s on ly

in en fo rc em en t pr oc ee din gs, not in ac tio ns bro ught

sol el y
un de r th e APA. But no c o u rt h as decided how the provision operates in an 2
en fo rc em en t a ct ionsuch as thi s on e, w he re the F D A ha s pr om ulg at ed ar eg ula tio n de cl ar ing apr oduc t a dul te rate d. Beca use there ar e no court decisions answer ing this questio n, th e d istrict court tu rn ed to l eg isl at ive his tor y in ane ff ort t o de te rm ine the int en t of Co ngr es s. T he Se na te Re port st at es : Se ct ion4 of the bil l adds tw o new pr ovi sio ns to the Fe de ra l Food , D ru g an d C osm et ic A ct

to pr ovi de fur ther

pow er to the F ood an d D ru g A dm ini str at ion to pr oc ee d w he re the sa fe ty of a die tarysupple m en t9

pose s r isk s to c onsu m ers. Fi rs t se ct ion4 pr ovi de s ne wpow er to the FD A to de cl ar e a die tary sup ple m en t a dul te rate d th ro ugh ru le m ak ing
. FD A m ay

use this po we r wh er e i t i s determ ined that a dietary supp le m en t pr es en ts a

“ subs tanti al a nd unr ea sona ble r isk of il lness or in jury und er co nd it io ns of us e reco m m en de d orsu gg es te d i n l ab el in g.” S. Rep. No. 103-410 , at 35 (1994 ) (e m phasis add ed). T he Report also explains that the section was intended “ to codify curre nt law that the governm ent bear the burden of proving dietary

suppl em ents adulterated.” Id

. at 36. T he Re port furthe r st ate s,

“ T he gov er

nm en t m ust pr oduc e the pr ep onde ranc e of the ev ide nc e as to the harm fu l effe cts from the dietary supp lem ent . . . .” Id

. A nd, the Re port c ite s United States v. 71/5 5 Gallon Drums of Stuffed Green O lives , 79 0 F . Sup p. 1 37 9 (N.D. Il l. 1 99 2) , a
ca se w he re the re w as no F D A r eg ula tio n de cl ar ing the f ood at iss ue a dul te rate d, in supp ort of i ts statem ents regarding the burden of proof. T hus, the legislative his tory cl e a r l y s t a t e s t h a tt h e g o v e rn m e n th a s t h e b u r d e n o f p r o o f i n a n e n fo rc em en t pr oc eed in g. Ho wev er, i t p r o vi de s n o g ui da nc e as to whet he r an d h ow an FDApr om ulg at ed r eg ula tio n de cl ar ing a pr oduc t ad ult er at ed m ay be use d as e vid en ce in
su ch a pr oc eed in g. O n a ppe al , H i- T ec h c onc ed es , a nd w e ag re e, that the de novo langua ge in the statut e doe s no t pr ev en t the G ove rn m en t f ro m usi ng the F ina l R

ule a s e vid en ce of adulteration in an enforcem ent proceeding. What Hi-T ech ar g u es is that the Final10

Ru le a lon e cannot

be suf fi ci ent evi de nc e of

a dul te ratio n and tha t the G ove rn m en t
m ust pr es en t the dis tr ic t c ourt wi th som e add iti ona l proo f tha t the pr oduc t su bj ec t t o forfe iture “ p re s en ts a significant or unreasonable risk of illn ess or injury ” under
recom m ended or ordinary

conditio ns of use in order to satisfy its burden. 21 U. S. C. § 3 42 (f)(1 )(A). W e dis ag re e. T he statut e doe s no t say that the appl ic ab ili ty of

ar eg ula tio n prom ulgated by an executive agency , through an extensive adm inistrative procedure,
cannot be suf fi ci en t pr oof

of a dul ter at ion
. A nd the le gis la tiv e his tor y doe s no t so ind ic at e. I nde ed , that hi sto ry sug ge sts the opp osi te : that th e statu te e m pow er s th e FD A to se ttl e the iss ue of a dul te ratio n th ro ugh ru le m ak ing an d th at a ddi tio na l pr oof to a co ur t wi ll no t b e n eces sa ry . See S. Rep . No. 1 03 -4 10 , at 3 5. Hav in g c on si de red t h e t e x t of t he st atut e an d i ts leg is la ti ve hi st ory , we conclude that Cong ress used the term d e n o v o t o indi cate that the G overnm ent had the b u r d e n o f

p r o o f , b y p r e p o n d e r a n c e o f

t h e e v i d e n c e , t h a tad i e t a ry s uppl em en t

“ presents a s ignificant or u nreasonable risk of i llness or injury ” under rec omm ended
orord in ary co nd it io ns of u se . 21 U.S
. C. § 3 42 (f)(1 )(A)

. In the absence of a
re gul at ionli ke th e Fi na l R ule , the G ove rn m en t w oul d have to carr y it s burd enby subm itt ing e vid en ce of

the r isk s of

il lness or

inj ur y und er the r ec om

m en de d or11

o r d i na ry co nd it io ns of u se . See e . g. , 7 1/ 55 G al l on D ru m s of

St uf f e d G re e n O l i v es , 790 F. S upp. 137 9. B ut, a s he re , w he re the F D A ha s a lr ea dy c onsi de re d e vid en ce of the r isk s, be ne fi ts a

nd u se s of

apr oduc t; pr opos ed

ar eg ula tio n a ddr es sin g th e product; is sued not ice of t h e propos ed regulation; cons idered com m ents on th at regulation and evid ence r elevant to that r egulation over a considerable period of tim e;
an d pr om ulg at ed ava lid F ina l R ule , it is suf fi ci en t f or the G ove rn m en t t o pr es en t
ev ide nc e tha t: (1 ) the r eg ula tion e xis ts and ( 2) it appl ie s to the pr oduc t tha t i s th e
su bjec t o f th e en fo rcem en t ac ti on . W e d o n ot read th e st atut e to req ui re m or e. VI. CONCLUSION Be ca use the part ie s agr ee tha t the F ina l R ule appl ie s to the se iz ed

pr ope rty , no genuin e issue of m aterial f act exists. T he district court properl y g ra n ted summ ary j udgm en t f

or the G ove rn m en t. AFFIR MED.