Download Y6 APR12 NO 2.5

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Y6 APR12 NO 2.5
10, 1996
CAROLINE MILES, Ph.D
Food and CWug Administration
Office of Special Nutrition
HFS-456
200 C Street South West
Washington D.C. 20204
i?E:
Distribution of Dietary Supplements
Dear Or. Miles:
As required by the Food and Drug Administration, I-am
her~%~ notifying you as representative of the Food and
Drug Administration within 30 days of first marketing the
following dietary supplements:
The names of the four products are the following:
NEAR7fi
NEAR & FAR’”A
TIRED EYES’M
Enclosed
are
the
four
individual labels pertaining to each
product (please see page two). Each label includes the
rewired
Statement
“These statements have not been
AdministrationThis
.
evaluated by the Food and Drug
product is not intended to diagnose, treat, cure, or
prevent any disease.”
I have on file substantiation for the nutritional support
statements presented on the labels.
If you have any questions, please do not hesitate to
contact me.
-,
Sincerely,
Roxanne Kubicek
President.
8roxtor( Laboratories.
Enclosure
(Four
TEL:310.264.5526
800.789.2478
FAX:
31O.453.5434
97 S-OY=L
Lal>els)
Inc.
E3
TON
O
YoRAToR4Es*[Nc
2730WilshireBoulevardSuite370, Santa Monica, CA 90403
Page
April
2
10,
1996
ENCLOSURE
*“*
Dietaty Suppfenwnt
@ SUPpOrtShe EyeS’Ability
to Focus NEAR””
30 GpslLfu
Dietary Suppkmm
to SwPoI-t the Eyes’Ability
to Focus FAR-*
30 Gpsuks
NEAR & FAR- is the fimt
nufdthal
Su@emnff#lfql@
-%?’-”.N-
formtsfated to support the
eyes’abflitytofoassupc&
andatadktance.’
‘nw
statements havenot
been evaluated b Me Food
and Ontg Mm ! ttkfmtion.
lltfs pmdusf k not intended
to diagnose, fre~ we w
4!%*
prevent
any
dfsease.
NEAR
&FAR-Is
manufactured
for BROXTON
exclusive
tASORATiRES, INC.
Sants MonicaCA9040s
O;etaty
Supplement
toSUpport
theEyes’ Ability
to Focus NEAR & FAR””
60 capsules
6 -TON
LA
SO
RAT
-.
Dietary
Supplement
for straind,
TIRED
60 Capsules
EYES””
ORIE8
-
TfREfl EYES” is the orfghaal
and udque nutritional supplement speciallyformulated for
strained,TfREfl EYEs:”
“These afsfemettfshave not
been evaluated by the Food
and Drug Mmftrktrstion.
Tftis pmdud Is not Mended
to diagnose, treat, sure or
prevent any disease.
TIRED EYES” is manufactured
exclusively for f3ROXTON
LABORATORIES, INC.
Santa Monica,CA 90403