FI RST DI VI SI ON

BA RNES, P. J.

, BROWN and HODGES, JJ.

N O T IC E : M otions for r e c ons i de r a tion m us t be ph y sic a l ly r e ce iv ed i n our c le r k ’s offic e w ithin te n da y s of the da te of de c is ion to be de e m ed tim e ly file d.

https ://w w w

. ga a ppe a ls .us /r ule s

June 24, 2022



# I n th e Co u r t o f

A p p eals o f

G eo r g ia

A2 2 A0 17 0 . SM ITH v . HI-TECH PHARM ACEUTICALS, INC.

B R O W N , J u d g e.

Sh awn Sm i t h fi l ed t h i s s i n g l e-co u n t act i on ag ai n s t Hi -Tech Ph arm aceu t i cal s ,

In c., u n d er t h e Di s t ri ct o f Co l u m b i a Co ns u m er Pro ced u res an d Pro t ect i o n Act (“ DC

CPPA”), al l eg i n g t h at t he l ab el s o f cert ai n Hi -Tech d iet ary s u p p l e m en t s are

m i s l ead i n g t o co n s um ers

. Th e tri al co u rt g ran t ed H i -Tech ’ s m ot i o n fo r ju dg m en t o n

t h e p l ead i n g s , co n cl u d i n g t hat Sm it h ’ s cl ai m s are p reem p t ed b y t h e Fo o d

, Dru g , an d

Co s m et i c Act (“ FDCA”), 21 U.S.C. § 3 0 1 et seq ., an d t h at h is co m pl ai n t rai s es i s s u es

wi t h i n t h e p ri m ary j u ri s d i ct i o n o f t h e Fo o d an d Dru g Ad m i n i s t rat io n (“ FDA”), an d

d i s m i s s ed Sm i th ’ s co m

p l ai n t wi t h p reju d i ce. Sm i t h ap p eal s fro m t h i s o rd er. Fo r t h e

fo l l o w i n g reas o n s , we rev ers e i n p art

, affi rm i n p art

, v acat e th e ju d g m en t, an d rem an d

t h e cas e t o t h e t ri al co u rt t o d i s m i s s Sm i th ’ s co m p lai n t wi t ho u t p reju d i ce.On ap p eal fro m a g ran t o f ju d g m en t o n t h e pl ead i n gs , we co n d uct

a d e n o v o rev i ew of t h e t ri al co u rt ’ s o rd er t o d e t erm in e wh et h er th e

u n d i s p ut ed fact s ap p eari n g fro m t h e p l ead i n g s en t i t l e t h e m ov an t t o ju d g m en t as a m at t er o f law. Th e gran t o f a m o t io n fo r ju d g m en t o n th e

p l ead i n g s u n d er OCGA § 9 -1 1 -1 2 (c) i s p ro p er o n l y w h e r e t h ere i s a

co m p let e fai l u re t o s t at e a cau s e o f act i o n o r d efen s e. Fo r p u rp o s es o f

t h e m o t io n, al l wel l -p l ead ed m at eri al al l eg at i o n s b y t h e n o n m o van t are

t ak en as tru e, an d al l d en i al s b y t he m o van t are t ak en as fa l s e

. B u t th e

t ri al co u rt n eed n ot a d o p t a p art y ’ s l eg al co ncl u s io n s b as ed o n t hes e

fact s

.

(Ci t at i o n an d p u nct u at io n o m i tt ed .) BCM Co ns t r

. Gr o u p v. W il li a m s , 3 5 3 Ga. Ap p.

8 1 1

, 8 1 1 -8 1 2 (8 4 0 SE2 d 5 1) (2 0 2 0 ). “ A m o t i o n fo r ju d g m en t o n t h e p l ead i n g s s h o u ld

b e g ran t ed o n ly i f th e m o v i n g p art y i s cl earl y en t i t l ed t o ju d g m en t .” (Ci t at i o n an d

p u n ct u at i o n o m i t t ed .) Po l o Go l f & Co u n t r

y Cl u b Ho meo wn er

s A s s n

. v. Cu n a r d

, 3 0 6

Ga. 7 8 8 , 7 9 2 (2 ) (8 3 3 SE2 d 5 0 5 ) (2 0 1 9 ).

Acco rd i ng to Sm i th ’ s co m p l ai n t, h e was a res i d en t o f t h e D i s tri ct o f Co l u m b i a

wh o p urch as ed Hi -Tech ’ s p ro d u ct

, “ Hy p d erd ri v e 3 .0 +,” w h i ch co n tai n s o x i l o fri ne,

al s o cal l ed m et h y l s y

n ep h ri n e. 1 “ Th is pu rch as e i n cl u d ed t h e p u r p o s e o f tes t i n g an d

1 Sm i t h o ri g i n al l y fi l ed a cl as s act i o n co m p l ai n t i n t h e Su p eri o r Co urt fo r t h e Di s t ri ct o f Co l u m

b i a, b ut t h e co u rt g ran t ed H i -Tech ’ s m o t i o n t o d i s m is s t h e co m p l ai nt
fo r l ack of p ers o n al ju ri s d i ct i o n

. Sm i t h s u b s eq u en t l y fi l ed th e in s t an t act i o n i n t h e Su p eri o r Co urt o f Gwi n n et t Co u n t y

.

2ev al u at i ng wh et h er Hy p d erd ri v e 3

. 0 + o r an y o t h er p ro d u ct s o ld b y [Hi -Tech ] wi th

m et h y l s y n ep h ri ne h av e b een u nl awfu ll y an d d ecep t i v el y s o ld [.] ” Sm it h al leg es t h at

Hi -Tech m an ufact u res an d d i s t ri b u tes d i et ary s u p p l em en t s i n th e Un i ted St at es wh i ch

co n tai n m et hy l s y n ep h ri n e, w h ich i s “ an u n ap p ro ved d ru g i n g red ien t ” an d “ i l l eg al

s u p p lem en t in g red i en t ,” an d wh i ch m ay po s e h eal t h ri s k s t o co ns u m ers

. A cco rd i n g

t o t h e co m

p l ai n t

, t h e FDA i s s u ed warn i n g l et t ers t o s e v e n co m p an i es reg ard i n g

p ro d uct s m ark et e d a s d i et ary s u p p l em en t s wh o l i s t m et h y ls y n ep h ri n e as a d i et ary

i n g red i en t b ecau s e m et h y l s y n ep h r i n e do es n o t m eet t h e FDCA’ s d efi ni t i o n o f a

d i et ary i ng red i en t

. Th u s , Sm i t h a l l eg es , t h e i n cl us i o n o f m et h y l sy n ep h ri n e in

H yp d erd ri v e 3 .0 + an d o t h er Hi -Tech p ro d u ct s i s a d ecep t i v e an d u n l awfu l t r a d e

p ract i ce b ecau s e i t creat es a t en d en cy t o m i s l ead reas on ab l e co n s u m ers i n t h e Di s t ri ct

o f Co lu m b i a.

Sm i t h b r o u g h t a cl ai m un d er t h e DC CPPA, “ act [i n g ] fo r t h e b en efi t o f t h e

[g ] en eral [p ] u b l ic as a Pri v at e At t o rn ey Gen eral ,” cl ai m i n g t hat Hi -Tech (a) fai l ed to

s t at e m at eri al fact s reg ard in g t h e p ro d u ct ’ s co n ten t s t h at ten d t o m is lead b y o m i t t i n g

t h at m et hy l s y n ep h ri n e i s an u n ap p ro v ed d ru g t h at h as b een l i n k ed to ad v ers e h eal th

e v e n t s an d o m i t t i ng t hat co n su m p ti o n o f t h e p ro d uct i n acco rd an ce wi t h t h e l a b e l

3i n cl u d es a n u n a p p r o v ed d ru g i n g red ien t at co n cen t rat i o ns o r d o sag es s u i t ab l e fo r

p res cri pt i v e m ed i cal p u rp o s es ; (b ) m i s rep res en t s a m at eri al fact i n cl ai m i n g t h at

H yp d e r d r i v e 3 .0 + i s a “ ‘ s y n erg i s t i c bl en d o f p o ten t h erb al d eri v at i v es ’ wh i ch i t i s

n o t ”; (c) “ [u ] s es i n n u en d o o r am b ig u i t y as t o a m at eri al fact reg ard in g t h e pro d u ct ’ s

co n ten t s , b ecau s e co n s u m e rs m ay co nfu s e ‘ m et h y l s y n ep h ri ne’ wi t h ‘ s y nep h ri n e,’ a

l eg al s u p p l em en t i n g red ien t ”; (d ) s el l s co ns u m er g oo d s i n a co n d i t i o n o r m an n er n ot

co n si s t en t wi t h t h at warran t ed by o p erat i o n o f t h e DC CPPA i n th at Hy p erd ri v e 3 .0 +

i s n o t m erch an t ab l e; an d (e) “ s el l s co ns u m er g o o d s i n a co n d it io n o r m an n er n ot

co n si s t en t wi t h o p erat i o n o r req u i rem en t o f fed eral l aw.” Sm it h s o ug h t act u al

d am ag es , s t at u to ry d am ag es , p u n i t ive da m a ge s, i n j u n ct iv e rel i ef, an d at to rn ey fees fo r

h i m s el f an d al l o t h ers s i m i l arl y s i t u at ed

.

Hi -Tech fi l ed a m o t i o n fo r ju dg m en t o n t h e p l ead i ng s , arg ui n g t h at Sm i t h ’ s

cl ai m s are i m

p l i ed l y p reem

pt ed b y t h e FDCA b as e d o n t h e Un i t ed St at es Su p rem e

Co u rt ’ s d eci s i on i n Bu ckma n Co

. v. Pl a i n t i f f s ’ Leg a l Co mmi t t ee , 5 31 U. S. 3 4 1 (1 2 1

SCt 1 0 1 2

, 14 8 LE2 d 8 5 4 ) (2 0 01 ). Hi -Tech al t ern at i v el y arg u ed t h at t h e t ri al co u rt

s h o u ld d i s m i s s Sm i t h ’ s cl ai m i n d eferen ce t o t h e FDA u n d er t h e d o ct ri n e o f p ri m ary

ju ri s d i ct i o n

. Th e t ri al co u rt co n cl u d ed t h at Sm i t h ’ s co m pl ai n t i s p reem

pt ed b y fed eral

4l aw an d rai s es i s s u es wi t h i n t h e p ri m ary ju ri s d i ct i o n o f t h e FDA an d d i s m i s s ed

Sm it h ’ s co m

p l ai n t wi t h p reju d ice.

Sm i t h ap p eal s fro m t h i s o rd er, an d co n t en d s , i n rel at ed en u m erat i on s o f erro r,

t h at t h e tri al co u rt erred in co n cl u d i n g t hat h i s cl ai m s are i m p l i ed l y p reem

pt ed b y t h e

FDCA an d i n fi n d i ng t h at t h e d o ct ri n e o f p ri m ary ju ri s d ict i o n ap p l ies t o h i s cl ai m s

.

W e co n cl u d e th at Sm it h ’ s cl ai m s are n ot s u b ject t o p reem

p t i on , ei t h er ex p res s o r

i m p l i ed , b u t d o fal l wi th i n t h e p ri m ary ju ri s d i ct i o n o f t he FDA.

1

. Pr eemp t io n. “ Th e p reem p t i o n d o ct ri n e i s a p ro d u ct o f t h e Su pr e m a c y C la u s e,

s ee U. S. Co n s t

., Art

. V I, Cl

. 2

, wh i ch i n v al i d at es s t at e l aws t h at i n t erfere wi th

, o r are

co n trary t o , fed eral law.” (Ci t at i o n an d p u n ct u at i o n om i t t ed .) Fo x v. No r f ol k S. Co rp

. ,

3 4 2 G a. Ap p. 3 8

, 4 3 (1 ) (8 0 2 SE2 d 3 1 9 ) (2 0 1 7 ). See al s o Rei s v. OOIDA Ri s k

Ret en t i o n Gr o up , 3 0 3 Ga. 6 5 9 , 6 6 0 (8 1 4 SE2 d 3 3 8 ) (2 0 1 8 ).

W h et h er fed eral s t at u t es o r reg u l at i o n s p reem p t s t at e l aw i s a q u es t i o n

o f co n g res s i o n al i n t en t

. Co n g res s

— t h r o u g h fed eral laws an d

reg u lat i o n s

— m ay effect i vel y p reem p t s t at e l aw in th ree way s: (1 )

ex p res s p ree m

p t i o n ; (2 ) fi el d p reem

p t i o n (reg u l at i ng t h e fi el d s o

ex t en s iv el y th at Co n gr e s s cl earl y i n t en ds th e s u b ject area to be

co n t ro ll ed o n l y b y f

e deral l aw); an d (3 ) im

pl i ed (o r co n fl i ct ) p reem

p t i o n

.

5(Ci t at i o n an d p u n ct u at i o n o m i t t ed .) G en t r y v. Vo l ks wa g en o

f Amer i ca , 2 3 8 G a. Ap p.

7 8 5

, 7 8 7 (2 ) (5 2 1 SE2 d 1 3 ) (1 9 9 9 ). “ Ex p res s p reem p t io n i s p res en t wh en Co n g res s ’ s

i n t en t t o p reem

pt s t at e l aw i s ex pl i ci tl y s t at ed i n t h e st at ut e’ s l an g u ag e.” (Ci tat i o n an d

p u n ct u at i o n o m i t t ed

. ) Ca n a l e v. Co l g at e-Pa l mo l ive Co

. , 2 5 8 FSu p p.3 d 3 1 2

, 3 1 9 (II)

( B ) ( S

. D

. N.Y. 2 0 1 7 ). “ A co u rt ’ s i n q u i ry i n t o th e s co p e o f a s t at u t e’ s p re-em p t i v e

effect i s g u i d ed b y t he ru l e t hat t h e p u rp o s e o f Co n g res s i s t h e u l t im at e t o u ch s t o n e in

ev ery p re[ ] em

p t io n cas e

. ” ( C ita

tion s an d p un ct u at i o n om i t t ed .) Al t r i a Gr o up v. Go o d

,

5 5 5 U

. S. 7 0

, 7 6 (II) (1 2 9 SCt 5 3 8

, 1 7 2 L E2 d 39 8 ) (2 0 0 8 ). W h et h e r fed eral l aw

p reem pt s s t at e l aw cl ai m s i s rev i ewed d e n o v o

. G e n t r y , 2 38 G a. Ap p

. at 7 8 6

. W i th

t h i s i n m i n d, we t u rn t o t h e fed eral s t at ut e at i s s ue.

Th e Fed er a l Fo o d , Dr u g , a nd Co s met i c Act

Th e FDCA, 2 1 U.S.C. § 3 0 1 et s eq ., as am en d ed b y t h e Nu t ri t i o n Lab el i n g an d

Ed u cat io n Act (“ NLEA”), 2 1 U.S.C. § 3 43 et seq ., g ov ern s t h e l a b e l i n g o f fo o d,

i n cl u d i n g d i et ary su p pl em en ts

. 2 In 1 9 9 4, Co n g res s fu rt her am en d ed t h e FDCA wi th

2 “ Th e NLEA was p as s ed t o ‘ cl ari fy an d t o st ren gt h en t h e F o o d an d Dru g Ad m i n i s t rat i o n’ s l eg al au t h ori t y t o req ui r e n u t r i t i o n l ab el i n g o n fo o d s , an d to

es t ab l i s h t h e ci rcu m s t an ces u n der w h i ch cl ai m s m ay b e m ad e ab o u t t h e n u t ri en t s i n fo o d s.’ ” Nu t r i t i on al Hea l t h A l l i a n ce v. S h a l a la

, 14 4 F3 d 2 20

, 2 2 3 (I) (2 n d Ci r. 1 9 9 8 ).

“ Pu rs u an t t o t hat g ran t o f au t ho ri t y , Co n gres s t as k ed t he FDA w i t h es t ab li s hi n g an d

m ai n t ai n i n g a u n i fo rm fed eral s ch em e of fo o d reg ul at i o n t o en s u re t h at fo od i s l ab el ed

i n a m an n er t h at d o es n o t m i s l ead co n s u m ers .” Gr een fi el d v. Y u ca t a n Fo o d

s , 1 8

6t h e Di et ary Su p p l em en t H eal t h an d Ed u cat i o n Act (“ DSHEA”), Pu b

. L

. No

. 1 0 3 -4 1 7,

1 0 8 St at

. 4 3 2 5 .3

. “ Th e NLEA an d DSHEA t og et h er es t ab l is h ed a n e w cat eg o ry o f

fo o d p ro d u ct s

— s p eci fi cal l y , d i e t ary s u p p l em en t s

— t h at h av e u n i q ue s afet y ,

l ab el in g , m an u fact u ri n g, an d o th er rel at ed s t an dard s. ” K r oe ssle r v

. C V

S Hea l t h Co rp

. ,

9 7 7 F3 d 8 0 3

, 8 0 8 (I) ( 9 t h C i r

. 2 0 2 0 ). See al s o 2 1 U.S.C. § 3 2 1 (ff) (“ a d i et ary

s u p p lem en t s h al l b e d eem ed t o b e a fo o d wi t h i n t h e m ean i ng o f t h i s ch ap t er”).

“ To en su re n at i o n wi d e u n i fo rm it y i n lab el i ng s t an dard s , Co n g r e s s h as

p ro h ib i t ed s t at es fro m d i rect l y o r i n d i rect l y e s t a b l i s h i n g u n der an y au t h o ri t y o r

co n ti n u i n g i n effect an y l ab el i n g req u i rem en t fo r d i et ary s u p p l em en t s th at i s n ot

i d en t i cal t o t he req u i rem en t s art i cu l at ed in § 34 3 (r). § 3 4 3 -1 (a).” Fer r a r i v. Vi t a mi n

S h o p p e , N o

. CV 1 7 -1 0 4 75 -GAO, 2 0 2 2 W L 9 7 4 0 4 8

, at * 2 (III) (A) (D. Mas s

. M arch

3 1

, 2 0 2 2 ). See al s o Kr o es s l er , 9 7 7 F3 d at 80 8 (I) (“ Pri v at e p l ai n t i ffs m ay n o t b ri n g

act i on s to en fo rce v i o l a t i o n s o f t h e FDCA. In s t ead

, p ri v at e p l ai nt i ffs m ay b ri n g

an al o g o us s t at e l aw cl ai m s as l o n g as t h e FDCA d o es n o t p reem p t t h o se cl ai m s .”)

(ci t at i o n s o m i t t ed ). FDA reg u l at i o ns d efi n e t h e t erm “ n o t i den t i cal t o ” as fo l l o ws :

FSu pp .3 d 1 3 7 1, 1 3 73 (I) (b ) (S.D. Fl a. 2 0 1 4 ). Hi -Tech as s e r t s , in p as s i n g , t h at t h e NLEA i s “ u l t i m at el y i rrel ev an t t o t h is cas e,” b u t fai l s t o el ab orat e o n t h i s p o s i t i o n

.

7“ No t i d en t i cal t o ” d oes n o t refer t o t h e s p eci fi c wo rd s i n t h e req u i rem en t

b u t i n s t ead m ean s t h at t h e St at e req ui rem en t d i rect l y o r i n d i rect l y

i m p o s es o b l i g at i o n s o r co n t ai n s p ro v i si o n s co n cern in g th e co m p os i t i o n

o r l ab el i n g o f fo o d

, o r co n cern i n g a fo od co n t ai n er, t h at : (i ) A r e n o t

i m p o s ed b y o r co n t ai n ed i n t h e ap p li cab le pro v i si o n [o r reg u l at i o n ]

. . .

; or (i i) Di ffer fro m th o s e s p e c i f i c a l l y i m p o s ed by or co n t ai n ed in th e

ap p l icab l e p ro v i s i o n [o r reg ul at i o n .]

2 1 C.F.R. § 1 0 0 .1 (c) (4 ). Th e p reem p t i o n p ro v i s i o n ad d ed by th e NLEA “ h as b een

rep eat ed l y i n t erp ret ed no t t o p reem p t re q u i r e m e n t s im

p o s ed b y s tat e l aw t h at

effect i v el y p aral lel o r m i rro r t h e rel ev a n t s ect i o n s o f t he NLEA.” (Ci t at i o n,

p u n ct u at i o n , an d em

ph as i s o m i t t ed .) Hu gh es v. E s ter C Co

. , 9 9 FS u p p

. 3 d 2 7 8

, 2 8 4

(III) (E.D. N.Y. 2 0 1 5 ). Ad d it i o n al l y , “ a s t at e s t at u t e m i rro ri ng it s fed eral co u n t erp art

d o es n o t i m

p os e an y ad d i t i o n al req u i rem en t m erel y b y p ro v id i n g a d am ag e rem ed y

fo r co n d u ct t h at wo u l d o t h erwi s e v i o l at e fed eral l aw, ev en i f t h e fed eral s t at u t e

p ro v id es n o p ri v at e ri g h t o f act i o n .” Acker m a n v. Co ca -Co l a Co

. , No . CV-0 9 -0 3 9 5

(J G) (RM L), 2 01 0 W L 2 9 2 5 9 5 5

, at * 6 (E.D. N.Y. J u l y 2 1

, 2 01 0 ), ci t i ng Ba t es v. Do w

Ag r os ci en ces , 5 4 4 U. S. 4 3 1

, 43 2 (1 2 5 SCt 1 7 8 8

, 1 61 LE2 d 68 7 ) (2 0 0 5 ) (p reem p t i o n

o f ad d i t i o n a l r eq u i rem en t s “ d o es n o t p recl u d e St at es fro m i m p os i n g di fferen t o r

ad d it i o n al remed i es ”) (em ph as i s i n o ri g i n al ). “ W h ere t h ere is an ex p res s p reem p t i o n

cl au s e ap p l i cab l e to a p ro v i s i o n o f t h e FDCA, t h e Co u rt m u s t d et erm i ne w h et h er t h e

8s t at e l aw at i s s u e fal l s wi t h i n t h e s co p e o f t hat p reem p t i o n

. ” Sci o r ti n o v. Pep s i co , 1 0 8

FSu pp .3 d 78 0

, 7 9 8 (II ) ( C ) ( 1 ) ( N

. D. Ca. 2 0 1 5 ). An d

, “ [i ] n m ap p in g t h e s co p e o f a

p re[ ] em pt i o n cl au s e, th e Co u rt t y p i cal l y m u s t accep t t h e read i n g t hat d i s fav o rs p re[

] em p t i on .” Id

., ci t i n g Al t ri a , 5 5 5 U. S. at 77 (II). W e n o w tu rn t o t h e s t at e law at i s s ue,

t h e DC CPPA.

Th e Di s t r ict

o f Co l umb i a Co n su mer

Pr o t ect i o n Pr o ced

u r es Act

Th e Di s t r i c t o f Co l u m

b i a Co n s u m er Pro tect io n Pro ced u res Act

affo rd s a p an op l y of s t ro n g rem ed i es , i n cl u d i n g t reb l e d am ag es , pu n i t iv e

d am ag es an d at t o rn ey s ’ fees

, t o co n s um ers wh o are v i ct i m i zed b y

u n l awfu l t rad e p ract i ces

. Th e Act i s co n s t ru ed an d ap p l i ed li b eral l y an d

es t ab l i sh es a co n s u m er’ s ri g h t t o tru t hfu l i n fo rm at i o n ab o u t co n s u m er

g o o d s an d serv i ces t h at a r e p u rch as ed o r recei v ed in th e D is tri ct o f

Co l u m b i a.

(Ci t at i o n an d p u n ct uat i o n o m i t t ed .) Fr a n ken y v. Di s t

. Ho sp

. Pa r t n er

s , 2 2 5 A3 d 9 9 9,

1 0 0 4 (II) (A) (D.C. Ct . Ap p . 2 0 2 0 ). Th e ex pres s p u rp o s es o f t h e DC CPPA are t o

(1 ) as s u re t h at a ju s t m ech an is m ex i s t s t o rem ed y al l i m p r o p e r t r ad e

p ract i ces an d d et er t h e co n t i nu i n g u s e of s u ch p ract i ces ; (2 ) p ro m o t e,

t h ro ug h effect iv e e n f

o rcem en t

, fai r b us i n es s p ract i ces t h ro ug h ou t th e

co m m u n i t y ; an d ( 3 ) ed u cat e co ns u m ers t o d em an d h i gh st an d ard s an d

s eek p ro p er red res s o f g ri ev an ces . D.C. Co d e § 2 8 -3 9 0 1 (b )[.]

9(Pu n ct u at i on o m i t t ed .) Pr i ce v. In d ep en d en ce Fed

. S

a v. Ba n k

, 1 1 0 A3 d 5 67

, 5 7 3 (III)

(B) (D.C. Ct

. Ap p. 2 0 1 5). “ [T] h e s t at u t e as am en d ed ex p an d [s ] t h e p o ten t ial p l ai n t i ff

cl as s s o as t o p erm i t rep res en t at i v e act i o ns o n b eh al f of co ns u m ers , b ro ad l y d efi n ed

as ‘ t h e g en eral p u b l i c.’ ” (Ci t at i on an d p u n ct uat i o n o m itte d. ) R o t u n d a v. M a r r i o t t In t l

. ,

1 2 3 A3 d 9 8 0

, 98 4 (III) (D.C. Ct

. Ap p

. 20 1 5 ). Th e p ro vi s i o n s p ert i n e n t t o Sm i t h ’ s

co m p l ai n t p ro v i d e:

It s h al l b e a v i o l at i o n o f t h i s ch ap t er fo r an y p ers o n to en g ag e i n an

u n fai r o r d ecep t i v e t rad e p ract i ce, wh et her o r n ot an y co n s um er i s i n fact

m i s l ed , d ecei v ed o r d am ag ed t h ereb y , i n cl u d i n g t o :

. . . ( e ) m i s rep res en t as t o a m at eri al fact wh ich h as a t en d en cy t o

m i s l ead ; . . . (f) fai l t o s t at e a m at eri al fact i f s uch fai l u re t en d s t o m is l ead ; (f-1 ) Us e i n n u en d o o r am b i g u i t y as t o a m at eri al fact , wh i ch h as

a t en d en cy

t o m i s l ead [.]

D.C. Co d e § 2 8 -3 9 0 4 (e), (f), (f

- 1 )

. “ Fo r cl ai m s o f m i s rep res en t at i o n, t h e s t at u t e

m erel y pro v i d es t h at i t i s a v i o l at i o n o f th e DC CP P A if t h e m erch an t

‘ m i s rep res en t ed ’ o r ‘ fai l ed t o s t at e’ a m at eri al fact .” Fr an ken y , 2 2 5 A3 d at 1 0 0 5 (II)

(A). See D.C. Co d e § 2 8 -3 9 0 4 (e) an d (f).

Fo r p u rp o s es o f § 2 8 -3 9 04 (e) o r (f), a m i s rep res en t at i on o r o m i s s i o n i s

‘ m at eri al ’ i f a reas o n ab l e p ers o n w o u l d at t ach i m p o rt an ce to i t s

10ex i s ten ce o r n o n ex is t en ce i n d et erm i n i n g h i s o r h er ch o i ce o f act i o n i n

t h e t ran sact io n o r t he m ak er o f t he rep res en t at i o n k n o w s or h as reas o n

t o k n o w t h at t h e reci p i e n t l i k el y reg ard s t h e m at ter as im po rt an t i n

d et erm i ni n g h i s o r h er ch o i ce o f act i o n

.

(Ci t at i o n an d p u n ct u a t i o n o m i t t ed .) Fr a n ken y , 22 5 A3 d at 10 0 5 (II) (A). See al s o

S a u ci er v. Co u n t r ywi d e Ho me Lo an s , 6 4 A3 d 4 2 8 , 4 4 2 (D.C. Ct . Ap p

. 2 0 1 3 ).

Exp r es s Pr eemp t i o n

Lo o k i n g t o t h e DC CPPA, as rai sed i n Sm i t h ’ s co m p l ai n t

, as wel l as t h e FDCA,

as am en d ed b y t h e NL E A an d DSHEA, we co n cl u d e t h at Sm i th ’ s cl ai m s are n ot

ex p res s l y p reem p t ed b y 2 1 U.S.C. § 3 4 3 -1 (a).

Th e FDA h as li m i t ed au t h o ri t y u n d er t h e (FDCA) t o re g u l a t e d i et ary

s u p p l em en t s , wh i ch i n cl u d e v i t am i n , b o t an i cal

, en zy m e, an d am i n o aci d

p ro d u ct s

. Un l ik e wi t h d ru g s , t h e FDA d o es n o t pre-ap pro v e p ro d uct

l ab el s fo r d i e t a ry su p p l em en t s. It

, h owev er, req u i res t h at th e l ab el s be

t ru t h fu l an d n o t m i sl ead in g , 2 1 U.S.C. § 3 4 3 (r) (6 ) (B)[.]

Gr een b er g v. Ta r g et Co r p. , 9 8 5 F3 d 6 5 0

, 65 4 (I ) (9 t h Ci r. 2 0 2 1 ). See al s o Fer r ar i

,

Sl i p o p

. at * 2 (III) (A) (“ 2 1 U.S.C. § 3 4 3 (r) p l aces l i m i t s on h eal t h cl ai m s t h at m ay

b e m ad e o n fo o d an d di et ary su p p l em en t l ab el s ”) (ci t at i o n an d p u n ct uat i o n o m i t t ed ).

Acco rd in g t o FDA reg ul at i o ns , a s u p p l em en t ’ s l ab el i s m i s l ead in g i f i t

11fai l s t o rev eal fact s t h at are: (1 ) M at eri al i n l i g ht of o t her rep res en t at i o n s

m ad e o r s u g g es t ed b y s t at em en t

, wo rd

, des i g n, d ev ice or an y

c om b i n at io n t h ereo f; o r (2 ) M at eri al wi t h res p ect t o co n s eq u en ces w hic h

m ay res u l t fro m u s e o f t h e art i c l e u n d er: (i ) Th e co n d i t i o n s p res cri b ed

i n s u ch l ab el i n g o r (i i ) s u ch co n d it i o n s o f u s e as are cu s t o m ary o r u su al

.

2 1 C.F.R. § 1 .2 1 (a). Th u s , “ i f a s u p p l em en t ’ s l ab el reco m m en d s tak i n g o n e cap s u l e

p er d ay , an d t h at do s e act u al l y cau s es an i n cre a s e d ri s k of d eat h

— a m at eri al fact

‘ w i t h res p ect t o co n seq uen ces w h i ch m ay res u l t fro m u s e o f t h e art i cl e’

— t he FDCA

wo u l d d eem i t m i s l ead i n g no t t o rev eal th at fact o n t h e l ab el .” (Ci t at i o n o m i t t ed .)

Da ch a u er v. NB T Y

, I n c. , 9 1 3 F3 d 8 4 4

, 8 4 9 (B) (9 th Ci r. 2 0 1 9). If t h ere are o t h er

rel ev an t fed eral req u i rem en t s g o v ern i n g Hi -Tech ’ s p ro d u ct

, i .e., p ro v i s i o ns o f t h e

FDCA, NLEA, or DSHEA, t h ey m u s t b e c o m

p ared t o th e req u i rem en t Sm i t h s eek s

t o i m p o s e v ia s tat e l aw. See Ca n a l e , 2 5 8 FSu p p .3 d at 3 2 0 (II) (B). Cf. B i mo n t v.

Un i lever U.S

. , No

. 14 -CV-7 7 4 9 (J PO), 2 0 1 5 W L 5 2 5 69 8 8, at * 4-5 (S.D. N.Y. Sep t

.

9

, 2 01 5 ) (b o t h s t at e an d f e d e r a l l aw g en eral l y fo rb i d “ ‘ m i sl ead i ng ’ p ack ag i n g o f

d r[u ] g s an d co s m e t i c s ,” p ro p er i n q u i ry i s wh et h er Co n g res s an d / o r FDA h as

ad d res s ed s p eci fi c su b

ject m at t er o f pl ai n t i ff’ s cl ai m s ). Bu t as p rev i o us l y s t at ed

, t h e

FDA h as l i m i t ed au t h o ri t y u n d er t h e FDCA t o reg u l at e d i et ary s u pp l em en ts an d d o es

n o t p re-ap p ro v e p ro d u ct l ab el s fo r d i et ary s up p l em en t s

. Gr een b er g , 9 8 5 F3 d at 6 5 4

12(I). An d we h av e i d en t i fi ed n o o t h er rel ev an t p ro v i s i o n g o v ern i n g d i et ary s up p l em en t

l ab el s i m p l i cat ed b y Sm it h ’ s cl ai m s ap art fro m t h e req u irem en t t h at th ey b e t ru t h fu l

an d n o t m i s l ead i n g

.

Here, Sm i t h al l eg es th at t h e p ro d u ct l ab el i s m is l ead i n g u n d er t h e D C C PPA

i n t hat i t fai l s t o d i s cl o s e t h at co n s um p t i on o f m et h y ls y

n ep h ri n e i n acco rd an ce wi th

t h e lab el can l e a d t o a d v ers e h eal th ev en t s an d wo ul d l ead t o co ns u m p t i o n o f

m et h y l s y n ep h ri n e a t co n cen t rat i o ns o r do s ag es s u i t ab l e fo r p res cri p ti v e m ed i cal

p u rp os es , b o t h o f wh i ch are m at eri al m i s rep res en t at i o ns o r o m i ss i on s u n d er t h e

FDCA. See Da ch a u er , 91 3 F3 d at 8 4 9 (B). Becau s e t h e FDCA a n d t h e D C CPPA

h av e t he s am e req u i rem en t i n t h i s res p ect

, § 3 4 3 -1 (a) (5 ) d o es n o t p reem p t t h es e

p art i cu l ar cl ai m s

. See i d

. See al s o Y el d o v. Mu scl ePh a r m Co r

p

. , 2 9 0 FSu p p .3 d 7 0 2,

7 1 4 (III) (F) (E.D. M i ch

. 2 0 17 ) (p l ai nt i ff’ s cl ai m s u nd er st at e l aw, al l eg i n g “ ‘ fal s e an d

m i s l ead i n g ’ ” d i et ary s u p p l em en t l a b el s an d ad v ert i s i n g , “ p aral l el t h e FDCA’ s

req u i rem en t s ” an d t h erefo re p l ai n t i ff’ s cl ai m s are n o t p reem p t ed b y t h e FDCA).

Sm i t h al s o cl ai m s t h at t h e p ro d uct l ab el v i o l at es t h e DC CPPA i n th at i t fal s el y

cl ai m s t h at Hy

pd erd ri v e 3 .0 + is a “ ‘ s y n erg i st i c b l en d o f p o ten t h erb al d eri v at i v es ’ ”

an d l i s ts m et h y l s y n ep h ri n e as a d i et ary i n g red i en t wh en i t d o es n o t m eet t h e FDCA’ s

13d efi n i t i o n o f d i et ary i n g red i en t o r s u p pl em en t

. 3 Ag ai n , t h e s t at e req u i rem en t

effect i v el y p aral l el s t h e fed eral req u i rem en t t h at th e lab el n o t b e m i s l ead i n g i n t h a t

i t n o t m i s rep res en t o r o m i t a m at eri al fact

. Co m p are D .C. Co d e § 2 8-3 9 0 4 (e) an d (f)

wi t h 2 1 C.F.R. § 1 .2 1 (a). Cf. A s t i a n a v. Ha i n Cel es t i a l Gr o u p , 7 8 3 F3 d 7 53

, 7 5 7 -7 5 8

(I) (9 t h Ci r. 2 0 1 5 ) (p l ai n t i ff’ s cl ai m s t h at co sm et i c l ab el w as fal s e an d m i s l ead i n g

were no t ex p res s l y p reem p t ed b y FDCA’ s p ro hi bi t i o n o n s t at e o r lo cal g o v ern m en t

“ ‘ es t ab l i s h [i n g ] o r co n t in u[i n g ] i n effect an y req u i rem en t fo r l ab el i n g or p ack ag i n g

o f a co s m et i c t hat i s d i fferen t fro m o r in ad d it i o n t o , o r t h at i s ot herwi s e n o t i d en t i cal

wi t h ’ fed eral ru l es ”; p l ai n t i f f w as n o t as k i n g d efen d an t “ t o m od i fy o r en h an ce an y

as p ect o f i t s co sm et i cs l ab el s t h at are req u i red b y fed eral l aw” b u t rat h er “ cl ai m [i n g ]

3 Th e FDCA d efi n es “ di et ary s u pp l em en t ” as

a p ro d u ct (o t h er t h an t o b acco ) i n t en d ed t o s up p l em en t t he d i et th at b ears

o r co n t ai ns o ne o r m ore o f t h e fo l l o w i n g d iet ary i ng red i en ts : (A) a v i tam i n ; (B) a m i n eral ; (C) an h erb o r o t h er b o tan i cal ; (D) an am i n o aci d ; (E) a d i et ary s u bs t an ce fo r u s e b y m an t o su p pl em en t t h e d i et b y i n creas i n g t h e t o t al d i et ary i n t ak e; o r (F) a co n cen t rat e, m et ab o l i t e, co n s ti t uen t

, ex t ract

, o r co m bi nat i o n

o f an y i ng red i en t d es cri b ed i n cl au se (A), (B), (C), (D), o r (E)[.]

2 1 U.S.C. § 3 2 1 (ff) (1 ).

14d ecep t i o n as a res u l t o f ad v ert i s i n g s t at em en t s ”). In s u m , b ecau se Sm i t h ’s cl ai m s

u n d er th e D C CPPA m i rro r th e FDCA re q u i r e m e n t t h at l ab el s be t ru t h fu l an d n ot

m i s l ead i n g , t h ey es cap e ex p res s pr e e m p t i o n

. See Y

el d o

, 29 0 FSu p p .3 d at 7 14 (III) (F).

Hav in g fo u n d t h at t h e FDCA, as am en d ed b y t h e NLEA, d o es n o t ex p res s l y p reem pt

Sm it h ’ s cl ai m s u n d er t h e DC CPPA, we t u rn t o t h e i s s u e o f i m p li ed p reem

p t i o n

.

Imp l i ed Pr eemp t i o n

W h i l e t he “ ex is t en ce o f an ex p res s p reem p t i o n cl au s e d o es n o t n eces s ari l y

p recl u d e t h e p res en ce o f im p l i ed p reem

p t i o n ,” Ir vi n g v. Ma z da Mo t o r Co r p

. , 1 3 6 F3 d

7 6 4

, 7 68 (I) (B) (1 1 t h Ci r. 1 9 9 8 ), “ an ex pres s d efi n it i o n o f t h e p re-em p t i v e reach o f

a s t at u t e ‘ i m

p l i es ’

— i .e., s u p po rt s a reas o n ab l e i n feren ce

— t h at Co n g res s d i d n ot

i n t en d t o p re-e m

p t o t h er m at ters

. . . .” Fr ei gh t l i n er Co r

p

. v. Myr i ck

, 5 1 4 U. S. 2 8 0,

2 8 8 (IV) (A) (1 1 5 SCt 1 4 8 3 , 1 31 LE2 d 3 8 5) (1 99 5 ). Mo reo v er, t he NLEA co n t ai n s

an u nco d i fi ed ex p res s s av in gs cl au s e: “ Th e [NLEA] sh al l n ot b e co n s t ru ed t o p reem pt

an y p ro v i s i o n o f St at e l aw, un les s s u ch p ro v i si o n i s ex p res s l y preem p t e d u n d er [§

3 4 3 -1 (a)] .” Pu b. L. No

. 1 0 1 -5 3 5

, § 6 (c) (1 ). See Ha ns en Bever a g e Co

. v. In n o va t i o n

Ven tu r es , No

. 0 8 -CV-1 1 6 6 -IEG (POR), 2 00 9 W L 6 5 9 7 8 9 1, at * 1 0 (III) (B) (1 ) (b )

(S.D. Cal

. Dec. 2 3

, 2 0 0 9 ). Fed eral co u rt s rep eat ed l y h av e fo u n d t h at t h e N L E A ’s

s av i n g s cl au s e refl ect s t h at Co ng res s d i s av o wed an y i m p l i ed p reem

p ti o n

. See, e.g .,

15S c io r ti n o , 1 0 8 FSu p p .3 d at 8 0 7 (II) (C) (1 ) (b ); Br a z i l v. Do l e Fo o d C o

. , 9 3 5

FSu pp .2 d 9 4 7

, 9 5 7 (III) (A) (2 ) (N.D. Cal

. 20 1 3 ); Lo ckwo o d v. Co n Ag r a F o o d s , 5 9 7

FSu pp .2 d 1 0 2 8

, 1 0 3 2 (I) (B) (1 ) (a) (N.D. Cal

. 2 0 0 9); Hi t t v. Ar iz o n a Bever a g e Co

. ,

No

. 0 8 cv 8 0 9W Q H (POR), 2 0 0 9 W L 44 9 1 9 0

, at *4 (I) (C) (i i ) (S.D. Cal

. Feb

. 4,

2 0 0 9 ). See al s o Fa r m Ra i s ed S al mo n Ca s es , 4 2 Cal

. 4t h 1 0 7 7

, 1 0 9 1 (II) (A) (1 7 5 P3 d

1 1 7 0 ) (2 0 0 8 ).

No n et h el es s , Hi -Tech u rg es u s t o ad op t t he t ri al co urt’ s c oncl u s i o n th at Sm i t h ’ s

cl ai m s are i m

p l ied l y p reem

p t ed b y t h e FDCA b ecau s e Sm i t h

, i n es s en ce, s eek s to

en fo rce t h e FDCA. In s u p p o rt o f t h i s as s ert i o n , Hi -Tech p o i n ts to t h e Su p rem e

Co u rt ’ s ho l d i n g i n Bu ckma n t hat “ frau d o n t h e FDA” cl ai m s are i m p l ied l y p reem

p t ed

b y th e FDCA as am en d ed b y t h e M ed i cal Dev i ce Am en d m en ts o f 1 97 6

, 2 1 U.S.C. §

3 6 0 c et s eq ., (“ M DA”). 5 31 U. S. at 3 4 8 (I I )

. Ho wev er, Bu ckma n i n v o l v ed i m p l i ed

p reem pt i o n u n d er t h e M DA wh i ch i s d i s ti n ct fro m t h e N LEA. 4 See Co r b et t v.

Ph a rma Ca r e U.S

. ,

_ _ _ FSu p p.3 d

_

_ _ (III) (B) (2 ) (S.D. Cal

. 2 0 2 1 ). See al s o

Gu s ta v s o n v

. W

ri g ley Sa l es Co

. , 9 6 1 FSu p p .2 d 11 0 0

, 1 1 1 8 (III) (A) (2 ) (N.D. Cal

.

2 0 1 3 ). Co m

p are Mi n k v. S

mi t h & Nep h ew , 8 6 0 F3 d 1 3 1 9, 1 3 3 0 (IV) (A) (2 ) (1 1 t h Ci r.

4 In Bu ckma n , t h e pl ai n t i ffs s ued o n b eh al f o f t h o s e i n ju red b y t he u s e o f

o rt h o p ed i c b o n e s crews , cl ai m i n g t h at t h e d efen dan t m ad e frau d u l en t rep res en t at i on s

t o t h e FDA i n t he co u rs e o f o b t ai n i n g ap p ro v al t o m ark et th e screws

. 5 3 1 U. S. at 3 4 3.

162 0 1 7 ) (ap p l y i n g Bu ckma n t o co n cl u d e th at so m e o f p l ai n t i ff’ s cl ai m s i nv o l v i n g a h ip

rep l acem en t d ev i ce w ere i m p l i ed l y p reem

p t ed b y t he FDCA as a m e n d ed b y t h e

M DA). Ot her cas es ci t ed b y Hi

- T e c h i nv o l v e m ed i cal dev i ces , o v er-t h e-co u n t er

d ru g s, o r co s m et i cs , w h ich are s u b ject t o s tri ct er req ui rem en t s , an d / o r d o n ot

i m p l i cat e t he NLEA. See Mi n k

, 8 6 0 F3 d at 1 3 2 5 -1 3 2 7 (III) (p l ai n t if f ’s f a i l u re to

rep o rt cl ai m bas ed o n a d u t y to fi l e a rep o rt wi t h t h e FDA fo r m e d i c a l dev i ce was

i m p l i ed l y p reem

pt ed b y fed eral l aw; p l ai n t i ff’ s m an u fact u ri n g d efect cl ai m i nv o l v i n g

m ed i cal d ev i ce was n o t p reem p t ed ); Bo r ch en ko v. L’Or ea l U S A

, 3 8 9 FSu p p.3 d 7 6 9

(C.D. Cal

. 2 0 1 9 ) (co s m et i cs ); In r e Ba yer Co r p

. Co mb i n a ti o n As

p i r i n Pr o du ct Mkt

g.

& S a l es P r a ct i ces Li ti

g a t i o n , 70 1 FSu p p .2 d 3 5 6 (E.D. N.Y. 2 0 10 ) (d ru g ); Ri l e y v

.

Co r d i s Co r

p

. , 6 2 5 FSu p p .2 d 7 6 9 (D. M i nn

. 2 0 0 9 ) (m ed ical d ev i ce). See al s o

Ima gen et i

x v. Fr u t a r o m US

A

, No

. 1 2 CV2 8 2 3-GPC (W M C), 2 0 1 3 W L 6 4 1 9 6 7 4 (S.D.

Cal

. D ec. 9

, 2 0 1 3 ). W e decl i n e t o g i v e Bu ckma n t h e ex p an si v e read i n g u rg ed b y Hi

Tech an d ad op t ed b y t h e tri al co u rt i n i t s o rd er. Acco rd in g l y , t h e t ri al co urt erred in

fi nd i ng t h at Sm i t h ’ s cl ai m s are i m p li ed l y p reem pt ed b y t h e FDCA.

2

. Pr i ma r y Ju r i s d i ct i on

. Sm it h co n t en d s th at t h e t ri al co u rt erred i n d is m i s s i n g

h i s cl ai m s b as ed o n t he d oct ri n e o f p ri m ary ju ri s di ct io n . W e d i s ag ree.

17“ Pri m a r y ju ri s d i ct i on i s a ju d i ci al l y creat ed do ct ri n e wh ereb y a co u rt o f

co m p et en t ju ri sd i ct i o n m a y d i sm i s s o r s t ay an act io n p en d in g a res o l u t i o n o f s o m e

p o rt i on o f t h e act i o n s b y an ad m i n i s t rat i ve ag en cy .” ( C i t at i o n an d pu n ct u at i o n

o m it t ed .) S

mi t h v. GTE Co r

p

. , 2 3 6 F3 d 1 29 2 , 1 2 9 8 (I), n .3 (1 1 t h Ci r. 2 0 0 1 ). It i s “ a

p ru d en t i al d oct ri n e t h at p erm i ts c o u r t s t o det erm in e t h at an ot h erwi s e co g n i zab l e

cl ai m i m p l i cat es t ech n i cal an d p o l i cy q u es t i o n s t h at s h o u l d b e ad d res s ed in t h e fi rs t

i n s t an ce b y t h e ag en cy wi t h reg u l at o ry au t ho ri t y o v er th e rel ev an t in d u s t ry rat h er t h an

b y th e ju di ci al b ran ch .” (Ci tat i o n an d p u n ct u at i o n o m i t t ed .) As ti a n a , 7 8 3 F3 d at 7 6 0

(II). “ It i s u s efu l i n i n st an ces wh ere

. . . co u rt s d o hav e ju ri s d i ct io n o v er an i s s u e, b ut

d eci d e t h at a cl ai m req u i res res o l u t i o n o f an i s s u e o f fi rs t i m p res s i o n , o r o f a

p art i cu l arl y co m

pl i cat ed i s s u e t h at Co n g res s h as co m m it t ed t o a reg u l at o ry ag en cy .”

(Ci t at i o n an d p u n ct u at i o n o m i t t ed .) Rei d v. Jo h n s o n & Jo h n s on , 78 0 F3 d 9 52

, 9 6 6 (V)

(9 t h Ci r. 2 0 1 5 ). See al s o Bo yes v. S h el l Oi l Pr o d

uct s Co

. , 1 9 9 F3 d 1 26 0

, 1 2 6 5 (III)

(A) (1 1 t h Ci r. 2 0 0 0 ) (“ [t ] h e m ai n ju s t i fi cat i on s fo r t he ru l e o f p ri m ary ju ri s d i ct i o n are

t h e ex p ert i se o f t h e ag en cy d eferred t o an d t h e n eed fo r a u n i fo rm in terp ret at i o n o f a

s t at u te o r reg u l at i o n ”) (ci t at i o n an d p un ct u at i o n o m i t t ed ). Gen eral l y ,

[c] o u rt s co ns i der fo u r fact o rs wh en ap p l y i ng t h e pri m ary ju r i s d i ct i o n

d o ct ri n e: (1 ) t h e n eed t o res o l v e an i s su e t h at (2 ) h as b een p l aced b y

18Co n gres s wi t h i n t he ju ri s d i c t i o n o f an ad m in is t rat iv e b o d y h av i n g

r e g u l a t o ry au t h o ri t y (3 ) p u rs u an t to a s t at u t e t h at s ub ject s an i n du s t ry activity to a co m

p reh en si v e reg u l at o ry sch em e t h at (4 ) req u ires ex p ert i s e

o r u n i fo rm i t y

i n ad m i n i st rat i o n

. Th e fo u r fact ors are n o t ex cl us i v e an d

co u rt s s eem h eav i l y i n fl u en ced b y a fi ft h fact o r i n cas es i m p l icat i n g

FDA ju ri s d i ct i o n : wh et h er t h e FDA h as s h own an y i nt eres t i n th e i s s u es

p res en t ed b y t h e l i t i g an t s.

(Ci t at i o n s an d pu n ct u at i o n o m i t t ed .) S n yd er v. G re e n R oads of

Fl o r i d a , 4 3 0 FSu p p .3 d

1 2 9 7 , 1 3 0 7 -1 3 0 8 (III) (C) (i ii ) (S.D. Fl a. 2 0 2 0 ).

Th e fed eral “ ci rcu i t s are s p l i t o v er t h e s tan d ard of rev i ew of d eci s i o n s wh et h er

t o reco g n i ze t h e p ri m ary ju ri s d i ct i o n of an ad m i n i s t r a t i v e ag en cy .” S ou t h er n Ut a h

W i l d er n es s Al l i an ce v. Bu r ea u o f La n d Mg mt

. , 4 2 5 F 3 d 7 3 5

, 7 5 0 (IV) (1 0 t h Ci r.

2 0 0 5 )

. T h e Ten th Ci rcu i t al o n g wi t h t h e Fo u rt h an d Di s t ri ct o f Co l u m b i a Ci rcu i t s

rev i ew d eci s io n s reg ard i n g p ri m ary j ur isdic t ion unde r a n a bu s e o f d i s cret i o n s t an d ard

.

See Na t. Te l

. C o o

p

. As s n

. v. Exxo n Mo b il

, 24 4 F3 d 1 53

, 1 5 6 (II) (D.C. Ci r. 2 0 0 1 );

En vi r o nmen t a l Tech n o l o g y Co u n ci l v. S i er r a Cl u b

, 9 8 F3 d 7 7 4, 7 8 9 (II) (D) (4 t h Ci r.

1 9 9 6 ); B r u ma rk Co r

p

. v. S a m s o n Res o u rces C o r

p

. , 5 7 F3 d 9 4 1

, 9 4 7 -9 4 8 (II) (1 0 th

Ci r. 1 9 9 5 ). Ot h er ci rcu i t s rev iew s uch d eci si o n s d e no v o

. See, e.g ., News p a p er Gu i ld

o f S al em v. Ot t a wa

y News p a p er s , 7 9 F3 d 1 27 3

, 1 2 8 3 ( I I I) (1 s t Ci r. 1 99 6 ); In t l

.

Br o th er ho od o

f Tea ms t er

s v. A mer ica n Del i ver

y S vc. Co

. , 50 F3 d 7 70

, 7 7 3 (9 t h Ci r.

191 9 9 5 ); Na t

. Co mmu n i ca ti o n s As s n

. v. Amer i ca n Tel

. & Tel eg r a p h Co

. , 4 6 F3 d 2 2 0,

2 2 2 (2 d Ci r. 1 9 9 5 ). Bas ed o n Bo yes , 1 9 9 F3 d at 1 2 65 (II), i t s eem s t hat t h e El ev en th

Ci rcu i t Co u rt of Ap p eal s rev i ews d eci s i o n s t o ab s t ai n o n t h e b as i s o f t h e p ri m ary

ju ri s d i ct i o n d o ct ri n e fo r an ab us e o f d i s cret io n

. Th e S u p r e m e C o u rt o f Geo rg i a h as

n o t ye t wei g h ed i n o n t h e ap pl i cab l e s tan d ard o f rev i ew, b u t h as d es cri b ed p ri m ary

ju ri s d i ct i o n as a “ d i s cret io n ary do ct ri n e.” Ga

. Po wer Co

. v. Ca zi er , 3 03 G a. 8 2 0

, 8 2 4

(3 ) (8 1 5 SE2 d 9 2 2 ) ( 2 0 1 8). Gi v en t h i s l an g u ag e, as w el l as t h e El ev en th Ci rcu i t ’ s

ap p li cat i o n o f a n ab u s e o f d i s cret i o n s t an dard

, we w i ll rev i ew t h e t ri al co urt ’ s

d eci s i o n t o ap p ly t h e p ri m ary ju ri s d i ct i o n d o ct ri n e i n th i s cas e fo r an ab u s e o f

d i s cret i o n

.

W i t h reg ard t o p ri m ary ju ri s d i ct i o n , t h e t ri al co u rt fo un d as fo l l o ws in i t s o rd er:

Pri m a r y j ur i sdic t io n o ver t h e qu es t io n wh et h er m et h y l sy nep h ri n e s h o u l d

o r s h o u l d n ot b e d eem ed a l awfu l d i et ary i n g red i en t fal l s t o t h e FDA. To

d eci de Pl ai n ti ff’ s cl ai m , t h i s Co u rt wo u l d h av e t o wei g h ex t en si v e,

co n fl i ct i n g s ci en t ifi c ev i d en ce t o res o l v e i s s u es t h at “ h av e been p l aced

wi t h in t h e s p eci al co m

p et en ce” an d ex p ert i s e o f t h e FDA.

. . . T h e Co u rt

ex erci s es i t s d i s cret io n t o d i s m i s s t h e Co m p l ai n t t o d efer t o t h e FDA’ s

p ri m ary ju ri s d i ct i o n

.

Two fed eral d i s t ri ct co u rt s co n fro n t i ng nearl y id en t i cal i s s u es recen tl y i n v o k ed

t h e p ri m ary jur isd i ct i o n d o ct ri n e. See Qu i d er a v. Bl a cks t o n e La b s , N o

. 2 0 -CV-8 0 8 9 8,

202 0 2 1 W L 4 9 5 87 89 (S.D. Fl a. M ar. 8

, 2 0 2 1); Ro s a s v. Hi -Tech Ph a rma ceu t ica l s , No

.

CV 2 0 -0 0 4 3 3 -DOC-DFM

, 2 02 0 W L 5 3 6 1 8 78 (S.D. Cal

. Ju l y 2 9

, 2 0 2 0 ). In Ro s a s , t h e

p l ai n t i ffs b ro u g h t s u i t ag ai n s t Hi -Tech un d er Cal i fo rn i a st at e l aw aft er p urch as i n g

v ari o u s d i et ary s u p p l em en t p ro d u ct s co nt ai n i n g t hree su b st an ces , i n cl u d i n g

m et h y l s y n ep h ri ne. Sl i p o p. at * 1

- 2 ( I ) ( B). H i -Tech fi led a m o t i on t o d i s m i s s t h e

p l ai n t i f f s ’ c l ai m s, as s ert in g p ri m ary ju ri s d i ct i o n am o n g o t h er g ro u n d s

. Id

. at * 2 (I)

(B). Th e d i s t ri ct co u rt fo un d t h at t h e FDA’ s warn in g l et t ers r e g ard i n g t h es e

s u b s t an ces d i d n ot co n st i t ut e fi n al ag en cy act i o n an d t h u s t h e FDA h ad no t t ak en fi n al

ag en cy act i o n t o det erm i n e w h et h er t h e t hree s u b s t an ces are s afe fo r h u m an

co n su m p t i o n

. Id

. at * 3 -4 (III) (A). Th e co u rt fu rt h er co n cl ud ed t h at “ [w] h et h er [t h e

t h ree s u b s t an ces ] co n s t i tu t e d i et ary s up p le m e n t s u n d er DSHEA req ui res t h e

d et e r m i n a t i o n o f t ech n i cal an d s ci en t i fi c q u es t i o n s b es t l eft t o t h e FDA” as wel l as

u n i fo rm i t y i n ad m i ni st rat i o n. (Ci t at i o n an d pu n ct u at i o n om i t ted .) Id

. at *4 -5 (III) (B).

In Qu i d er a , t he p l ai n t i ffs b ro u g h t s u i t ag ai n s t a co m p an y d i s t ri b u t i n g an d

s el l i n g d iet ary s u p p l em en t s co n t ai n i n g t h e s t i m u l an t DM HA, al l eg i n g , i n t er al i a, t h at

t h e co m p an y fai l ed t o i n fo rm co n s u m ers t h at t h ei r p ro d u ct s co n t ai n ed an i ll eg al an d

u n s afe i n g red i en t

, f

a i l e d t o d is cl os e t h e t ru e nat u re o f, i l l eg al i t y o f, an d d an g er

as s o ci at ed wi t h DM HA, an d m ark et ed t h e p ro d u ct s as d i et ary su p pl em en t s b u t fai l ed

21t o i n fo rm co n s u m ers t h at t h e p r o d u ct s are no t

, in fact

, “ ‘ Di et ary Su p p l em en t s ’ ”

b ecau s e t h ey

co n t ai n an u n s afe fo o d ad d i t i ve an d a n o n-d i et ary i n g red i en t , DM HA.

Sl i p o p

. at * 1 (I). Th e co m p an y m o ved t o d i s m i s s on s e v eral g ro u n d s , i n cl u d i n g

p ri m ary ju ri sd i c t i o n , arg u i ng t h at t h e FDA h as n o t d eem ed DM HA i l l eg al an d t h e

p l a i n t i ffs ’ cl ai m s wo ul d u s urp t h e FDA’ s au t ho ri t y t o reg u l at e d iet ary s u p p l em en t s

u n d er t h e FDCA. Id

. at * 2 (I). Th e d i s t ri ct co u rt ag reed

, fi n d in g t h at t h e “ F D A h a s

ex p res s ed i n t eres t i n DM HA [i n t he fo rm o f warn i ng l et t ers ] b ut h as n o t t ak en fi n al

ag en cy act i o n t o d et erm in e wh et h er DM HA i s a d i et ary i n g red i en t, wh et h er i t i s s afe

fo r h um an c o n su m

p t i on an d / o r wh et h er i t is i ll eg al

. ” Id

. at *3 (III). M o reo v er,

d et erm i n i n g b as ed o n s ci en ce wh et h er DM HA i s s afe o r pro p erl y cl as s i fi ed as a n ew

d i et ary i n g red i en t, t h e co urt co n cl u d ed

, i s a p art icu l arl y co m p l icat ed i s s u e t h at

Co n g res s h as co m

m i t t ed t o t h e FDA. Id

. at * 3 (III). Acco rd i n g l y, t h e d i s t ri ct co u rt

d i s m i s s ed t h e p l ai n ti ffs ’ co m pl ai n t wi t ho u t p reju d i ce. Id . at * 4 (IV).

H ere, as i n Ro s a s an d Q u i d er a , t h e co m

p l ai nt p res en t s q u es t io n s o f w h e t h e r

m et h y l s y n ep h ri ne i s a d i et ary i n g red i en t as t h at t erm is d efi n ed b y t h e FDCA, wh et h er

co n su m p t i o n o f m et h y l s y

n ep h ri n e l ead s t o ad v ers e h eal t h co n s eq u en ces o r i s s afe fo r

h u m an co n s um

pt i o n , an d t h e p ro p er d o s ag e, i f an y , o f m et h y l s y n ep h ri n e. Su ch

q u es ti o n s i n v o l v e t h e ev al u at i o n o f c o n f l i ct i n g s ci en t ifi c ev i den ce in t h e co m p l ex

22areas o f p ro d u ct an d i ng red i en t cl as s i fi cat i o n an d h eal t h an d s afet y

— d et erm i n at i on s

t h at t h e FDA i s i n a b et t er p o s i ti o n t o m ak e. See Qu id er a , Sl i p o p

. at * 3 (III); Ro s a s ,

Sl i p op

. at * 4-5 (III) (B). See al s o As t i a n a , 7 8 3 F3 d at 76 1 (II) (“ [d ] et erm i n i n g wh at

ch em i cal co m

p o u n ds m ay b e ad v ert i s e d a s n at u ral o n co s m et i c p ro d u ct l ab el s i s ‘ a

p art i cu l arl y co m

p l icat ed i s su e t h at Co n g res s h as co m m it t ed t o ’ t h e FDA” an d t hu s

d i s t ri ct co u rt d id n o t err in i n v o k i n g pri m ary ju ri s d ict i o n ); B ra i n t r ee La b or a t o r i es v.

Nep hr o -Tech

, No

. 9 6

- 2 4 5 9

- J W L, 1 9 9 7 W L 9 4 2 3 7

, at *7 (II) (B) (D. Kan

. Feb

. 2 6,

1 9 9 7 ) (“ i t i s n o t fo r th i s co u rt t o i n t erp ret an d ap p l y t he s tat u t o ry d efi n i t i o n o f ‘ d i et ary

s u p p lem en t ’ ” b u t rat her i s an i s s u e “ res erv ed s o lel y fo r res o lu t i o n b y

t h e FDA”).

Sm i t h co n t en d s th at “ t he FDA h as al read y w ei g h ed t h e ‘ ex t en s iv e, co n fl i ct i n g

s ci en t i fi c ev i den ce’ an d, wi t h it s ex p ert i s e, d et erm i n ed t h at m et hy l s y n ep h ri n e [d o es

n o t q u al i fy as a] di et a r y i n g red i en t ” an d co n seq u en t l y i s su ed warn i n g l et t ers

.

Ho wev er, “ reg u l at o ry l et t ers d o n o t co n st i tu t e fi n al ag en cy act i o n.

. . . Th e fact

rem ai n s t h at t h e FDA h as n o t f o rm al ly es t ab l is h ed i t s p os i t i o n.” (Ci t at i o n an d

p u n ct u at i o n o m i t t ed

. ) Co l et t e v. CV S ci en ces , N o

. 2 : 1 9 -CV-1 0 2 2 7 -VAP-J EM (x ),

2 0 2 0 W L 2 73 98 6 1

, at * 4 (III) (B) (C.D. Cal

. M ay 2 2

, 2 02 0 ). See al s o Hi -Tech

Ph a rma ceu t i ca l

s v. H a h n , No

. CV 1 9 -1 2 6 8 (RBW ), 2 0 2 0 W L 3 4 98 5 8 8, at * 5 ( I I I)

(D.D.C. J u ne 2 9

, 2 0 2 0 ) (FDA w arn i ng l et t ers do n o t co n st i t u t e fi n al ag en cy act i o n ).

23Th i s wei gh s i n fav or o f d eferri n g t o t h e ju ri s d i ct io n o f t h e FDA. See C a n a l e , 2 5 8

FSu pp .3 d at 3 2 5 ( I I ) (C) (3 )-(4 ). Co m p are Jo n es v. Co n

Ag r a Fo od

s , 9 1 2 FSu p p .2 d

8 8 9

, 8 9 8 (III) (B) (N.D. Cal

. 2 0 1 2 ) (fact t h at v ari o u s p art i es h av e rep eat ed l y as k ed

t h e FDA t o ad o p t fo rm al ru lem ak i n g to d efi n e t h e wo rd “ n at u ral ” an d th e FDA h as

d ecl i ned t o d o s o wei g hs ag ai n s t ap p l y i n g p ri m ary ju ri sd i ct i o n ).

As p o i n t ed ou t i n Da b i s h v. Br a n d New En er g y , No

. 1 6 -CV-4 00 -BAS(NLS),

2 0 1 6 W L 7 04 8 3 19

, at * 4 (S.D. C a l

. D e c. 5

, 2 01 6 ), a cas e rel i ed o n by Sm i t h,

“ b ecau s e [p ri m ary

ju ri s d i ct i o n] i s a d i s cret i on ary d o ct ri n e, t h e co u rt m ay d ecl i n e t o

i n v o k e t h e d oct ri n e wh en d eci di n g t h e i s su e i s n o t o u t si d e t h e a b i l i t y o f t h e co u rt .”

In t hi s c a s e , t h e t ri al co u rt ex erci s ed i t s d i s cret i o n i n i nv o ki n g t h e d o ct ri n e an d

d eferri n g t o t h e FDA. Un d er t h e ci rcu m s t an ces , we co n cl u d e t hat t h e t ri al co u rt d id

n o t ab u s e i t s d is cret i on i n d o i n g so

. Ho wev er, g iv en o u r ho l d i n g in Di v i s io n 1

, t h e

t ri al co urt erred i n d i s m i s s i n g Sm i t h ’ s co m pl ai n t wi t h p reju d i ce. See Smi t h

, 2 3 6 F3 d

at 1 2 9 8 (I), n

. 3 (p u rs u an t to t h e p ri m ary ju ri s d i ct i on d oct ri n e, a co u rt m ay d i s m i ss o r

s t ay an act i o n p en d i n g a res o l u t i o n o f s o m e p o r t i o n o f t h e act i o ns b y an

ad m i n is t rat i v e ag en cy ). Ac c o r d i n g l y , we rem an d t h e cas e t o t h e tri al co u rt fo r

c o n s i d erat io n o f w h et h er a s t ay o r d i sm is s al wi t h ou t preju d ice i s t h e ap p ro p ri at e

24d i s p o s i t i on p u rs u an t t o t he p ri m ary ju ri s d i ct i o n do ct ri n e. See D a vel Co mmu n i ca t i on s

v. Qwes t Co r p. , 4 6 0 F3 d 1 0 7 5 , 1 0 9 3 (V) (9 th Ci r. 2 0 0 6 ).

Ju d g men t a f f i r m e d i n pa r t a n d r ever

s ed i n p a rt

, j u d g men t va ca t ed

, a n d ca s e

r ema n d ed wi t h d ir ect i on . Ba r n es , P. J., a n d Ho d g es

, J., co n cu r

.

25