Download 0 your letter of Janus ) pursuant to 2 and ~~srnet~~

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Waft
0 your letter of Janus
) pursuantto 2
and~~srnet~~
Act (theAct)).
makingtie following claims,amongothers,for the product
HeartHeafthFormula:
) makesclearthat s~tementincludedin
tion may not Claimta diagnose,rn~t~gat~
iseaseor classof diseases.The s~tementthat you
intendedto treat, prevent,cureor rn~t~gat~
a
is claim doesnot meetthe requirement of 2
is product is intendedfor useasa drug when the mea&g of 21
md that it is subjectto r latianuxlderthe dmg ~ruvisi~nsof the
‘s Center for
0~ should contact
makeclaimsof this na
esearch(CDER),Office of Compliance,HFD-3f Q,7520S
lace,Reveille, balled 20855,
e2se contactus if we maybe of furtherassis
anuary 14,20
Qtjfi~atj~n
ofcertain t
uant to section I
with this sec$ion.
Hea
i.
id~~t~f~~das ~s~~a~
address is 1195 Mc5
encl. appendix
cc: copies (2) blin
division of Chec
Ii