Download 376 NIV25 P2:23 ’98

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376
’98 NIV25 P2:23
Antonio C. Martinez, II., Esq.
8707 Brittany Drive
P.O. BOX 2060
Wayne, New Jersey 07474-2069
Dear Mr. Martinez:
This is in response to your letter of November 13, 1998, on behalf of American
Specialty Health & Wellness of San Diego, California, to the Food and Drug
Administration (FDA) pursuant to 21 U.S.C. 343(r)(6) (section 403(r)(6) of the Federal
Food, Drug, and Cosmetic Act (the Act)). Your submission states that American
Specialty Health & Wellness is making the following statements, among others, for the
products:
Astragulus Extract
“.. promote healing... ”
Vitamin
Vitamin
Vitamin
E Plus
C Complex
C Ester C
“.. healing of wounds”
Daily Multi-Mineral
Daily Multiple Vitamin + Mineral
“.. for healing . . .and resistance to illness”
21 U.S.C. 343(r)(6) makes clear that a statement included in labeling under the
authority of that section may not claim to diagnose, mitigate, treat, cure, or prevent a
specific disease or class of diseases. The statements that you are making for these
products suggest that they are intended to treat, prevent, mitigate, or cure diseases,
namely wound healing and general illnesses. These cIaims do not meet the
requirements of 21 U.S. C. 343(r)(6). These claims suggest that these products are
intended for use as drugs within the meaning of 21 U.S .C. 321(g)(l)(B), and that they
are subject to regulation under the drug provisions of the Act. If you intend to make
claims of this nature, you should contact FDA’s Center for Drug Evaluation and Research
(CDER), Office of Compliance, HFD-3 10,7520 Standish Place, Rockville, Maryland
20855.
97s-G/~
Page 2- Antonio C. Martinez, II, Esq.
Please contact us if we may be of further assistance.
Sincerely,
Lynn A. Larsen, Ph.D.
Director
Division of Programs and Enforcement
Office of Special Nutritional
Center for Food Safety
and Applied Nutrition
Copy:
+.
Policy
Dr. Doug Metz
American Specialty Health & Wellness
8989 Rio San Diego Drive
Suite 250
San Diego, CA 92108
Copies:
FDA, Center for Drug Evaluation and Research, Office of Compliance, HFD-300
FDA, Office of the Associate Commissioner for Regulatory Affairs, Office of
Enforcement, HFC-200
FDA, Los Angeles District Office, Office of Compliance, HFR-PA240
cc:
HFA-224 (w/incoming)
HFA-305 (docket 97 S-0 163)
HFS-22 [cCo)
HFS-456 (file)
HFS-450 (r/f, file)
HFD-31 O (BWilliams)
HFD-31 4 (Aronson)
HFS-600 (Reynolds)
HFS-605 (Bowers)
GCF-1 (Nickerson, Dorsey)
f/t: HFS-456:rjm:l l/17/98:docname:62292
.adv:disc33
C.
AtWONIO
GOVERNMENT
AT LAW
PUBLIC AFFAIRS
AND
8707
BRmANY
P.O.
WAYNE,
BoX
NEW
EWL.
.JERSE7.
NEW
YORK.
TONYMAKTINQ
C+smwn
OF
COUJME!W
COUNSEL
DFUVE
2069
NJ 07474-2069
TEL 973305
FAX.
Il.P.C.
MARTINEZ,
ATTORNH
973
I 235
305
3983
PARS
&0t4w5EWE.COH
November
13, 1998
Office of Special Nutritional
U.S. Food & Drug Administration
By Federal Express Courier Service, Tracking # 790165024108
Re: Statements of Nutritional Support Filings, American Specialty Health & Wellness,
San Diego, CA
Dear Sir/Madam:
As counsel for American Specialty Health & Wellness (ASHW), enclosed please
find an original and two copies of Statement of Nutritional for ninety three dietary
supplement products distributed by ASHW. Should you have any questions or require
any additional information, please do not hesitate to contact me.
Yours truly,
Antonio C. Martinez, Il. Esq.
cc: Dr. Doug Metz, ASHW
Anwican
Specially
HEAITH&WEllNES$
October
30, 1998
Office of Special Nutritional
HFS-450 Center for Food Safety and Applied
Food and Drug Administration
Us.
200
Nutrition
c St.sw
Washington
DC 20204
Statement of Nutritional
Support- DAILY MULTIPLE VITAMIN +
MINERAL
Pursuant to 21 CFR Part 101.93, American Specialty Health &
Wellness
(ASHW) files the following Statement of Nutritional
Support for the Dietary Supplement
marketed as: DAILY MULTIPLE
VITAMIN + MINERAL
1) Name and Address
Ste. 250, San Diego
of Distributor:
CA 92108
ASHW
8989 Rio
San Diego
Dr.
2) Text of Nutritional
Support Statement being Made:
“Daily Vitamin + Multiple Mineral is a combination
of vitamins
and minerals formulated
to provide additional
nutrient
A complete, balanced
supplementation
to the daily diet.
assortment
of essential minerals and other nutrients
is necessary
tissue
vitality
and
resistance
to
illness.”
for healing, growth,
3) Nama.of
4) Brand
dietary
DAILY
Name:
5) Substantiation
corporate
officer
President.
Yours
truly,
Dr . Doug Metz
Vice President
ingredient(s)
MULTIPLE
: See Attached
VITAMIN
Product
Label
+ MINERAL
information
on file at the company office.
who can certify same is Dr. Doug Metz, Vice
,
.
8989Rio San Diego Dr., Suite 250, San Diego, CA 92108
●
Phone 619/297-8100
●
Fax
619/209-6236
The
Daily Multiple
Vitamin
+ Minerals
Description:
anclrnincrals
~ormula(cd
[oprovideacldi[ional
nu[rienl
sLkp~]lell~ellca[iol]
Daily Multiple Vitamin Y Minera is a combination of vi[amins
to
ofessential
vitamins,
minerals
and othernutrien(s
isnecessary
forhealing,
growth.tissue
the daily diet. A complete, balanc d assortment
vitality and resistance to illness.
Thesestatementhavenotbeenevaluated
by theFood and Drug Administration
(FDA).Thisproductisnotintended
todiagnose,
treat,
cure or prevent any disease.
Suoolcmcnl Facls
DAIIY
MUITlVITAMIN
+MINERALS
DIETARY 5UPP1ENIN1
90 CAPSULES
I’fcmium
hucfuc(sjur
lbur //ccI//bG Ukllflrm ‘“
,
American
Specially
HEAITHMIIIE1lNESS”
october
30, 1998
Office of Special Nutritional
HFS-450 Center for Food Safety and Applied
U.S. Food and Drug Administration
200
c
Nutrition
St.sw
Washington
DC 20204
Statement
of Nutritional
Support- DAILY MULTI-MINERAL
Specialty Health &
Pursuant
to 21 CFR Part 101.93, American
Wellness
(ASHW) files the following Statement
of Nutritional
Support for the Dietary Supplement marketed
as: DAILY MULTIMINERAL
1 ) Name and Address
Ste. 250, San Diego
of Distributor:
CA 92108
ASHW
8989
Rio
San Diego
Dr.
2) Text of Nutritional
Support Statement being Made:
of mineral
“Daily Multiple Mineral is a unique combination
nutrients
formulated
to provide additional
nutrient
A
complete,
balanced
supplementation
to the daily diet.
assortment
of essential minerals and other nutrients
is necessary
to illness.”
for healing, growth, tissue vitality and resistance
3) Name
of dietary
ingredient(s)
: See Attached
Product
Label
-.
4) Brand
Name:
DAILY
information
on file at the company office.
who can certify same is Dr. Doug Metz, Vice
5) Substantiation
corporate
officer
President.
Yours
MULTI-MINEIWL
The
truly,
/ZGJT~
Dr. Doug Metz
Vice president
&
.
&g.%4$
8989 Rio San Diego Dr., Suite 250,San Diego,CA 92108@Phone619/297-8100”Fax619/209-6236
Daily Multiple
Mineral
1
Description:
Daily Multiple Mineral is a unique combination of mineral nu[rients formulated (o provide additional nutrient supplementation 10 the daily
diet. A complete, balanced assortment of essential minerals and other nutrients is necessary for healing, growth, tissue vitality and
resistance to illness.
Thesestatements
jlave
notbeenevaluated
by the Food and Drug Administration
(FDA).Thisproductisnotintended
todiagnose,
treat,
cureorpreventanydisease.
DAIIY
MUITI-MINERA1
Supplcmenl Facls
Sewing Sile 3 Iablels - Se!vmgs PeI ComaIneI 30
ham! r.r !,nlnt 104L(,V,b,
DIETARY $UPPL[HEHT
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American
Special[y
HEAITH&VVEllNESS
october
30, 1998
Office of Special Nutritional
HFS-450 Center for Food Safety and Applied
U.S. Food and Drug Administration
200
Nutrition
c St.sw
Washington
DC 20204
Statement of Nutritional
Support- VITAMIN C ESTER-C
Specialty Health &
Pursuant
to 21 CFR Part 10I.93, American
Wellness
(ASHW) files the following Statement
of Nutritional
Support for the Dietary Supplement
marketed
as: VITAMIN C ESTER-C
1) Name and Address
Ste. 250, San Diego
of Distributor:
CA 92108
ASHW
8989
Rio
San Diego
Dr.
2) Text of Nutritional
Support Statement
being Made:
that
“Vitamin C, also known as ascorbic acid, is an antioxidant
is required for proper tissue growth and maintenance
and adrenal
Ester C has naturally bonded minerals that
gland function.
help the body absorb the Vitamin C more quickly. Vitamin C
against bruising, and
supports a healthy immune system, protects
and the healing of
assists in blood clotting, tissue formation
wounds . Chewable C should be taken with food and chewed well, for
best absorption.”
-.
3) Name of dietary ingredient(s):
See Attached
Product Label
4) Brand
5)
Name:
VITAMIN
Substantiation
information
corporate
officer
PresidentYours
C ESTER-C
on
who can certify
file
same
at
the
company
is Dr.
Doug
The
office.
Metz,
Vice
truly,
In
/’L7?7q
Dr. Doug Metz
Vice President
.
~ ~,z
8989 Rio San Diego Dr., Suite250, San Diego, CA 92108.Phone619/297-8100*Fax619/209-6236
y-z
Ester Vitamin
(Ascorbic
I
Acid,
C
Polyascorbate)
Description:
Vitamin C, also known as ascorbic acid,k an antioxidant
that
k required
forpropertissue
growthand maintenance
and adrenalgland
function. Ester C has naturally bonded minerals that help the body absorb the vitamin C more quickly. Vitamin C supports a healthy
immune system, protects against bruising, and assists in blood clotting, tissue formation and the healing of woLmcis.
‘llese
sia[cmen[s
have
not been evaluated
by lhc Food and Drug Adlninis[mlion
(l;
DA). ‘1’1]]s
produc[is11o[
il~[cncitd
[odi:lgl~osc,
[rea[,
cure or prevent any disease.
VITAMIN
(
[STIR-(”
DIITARY SUP PIE HENT
lOOTABLETS
I’rcrl!llllrl
/’ro/url.s
Jf)r )’f)ur
Ilcfl
l//]& Wull/1(,*.\
‘“
Suuokmcn(
facts
Se;vIng
SIZe
1 Iablel Wamm
Sewmgs Pe! ComameI IMI
h,-?.
!4W %O+d,l*,
———
C (JJ[!ler-C@
caktum)
$03mi
811%
Cdrusbmllawootis
?CQmf
(CI!IU$ [red, $Id]5% bwllavmwd!l
.—. - ..—. —-—.—— — .Oliwrl~fedienti: (klalm, ccllukxt, CalCIUi-@’mpiIjIt
American
Specialty
HEAITH&VVEllNESS
october
30, 1998
Office of Special Nutritional
HFS-450 Center for Food Safety and Applied
Food and Drug Administration
Us.
200
c
Nutrition
St-sw
Washington
DC 20204
Statement
of Nutritional
Support- VITAMIN C COMPLEX
Pursuant
to 21 CFR Part 101.93, American Specialty Health &
Wellness
(ASHW) files the following Statement
of Nutritional
Support for the Dietary Supplement marketed as: VITAMIN C COMPLEX
of Distributor:
CA 92108
1) Name and Address
Ste. 250, San Diego
ASHW
8989
Rio
San Diego
Dr.
Support Statement being Made:
2) Text of Nutritional
that
“vitamin C, also known as ascorbic acid, is an antioxidant
and adrenal
is required
for proper tissue growth and maintenance
Vitamin C supports a healthy immune system,
qland function.
protects
against bruising, and assists in blood clotting, tissue
formation
and the healing of wounds. Chewable C should be taken
with food and chewed well, for best absorption.”
3) Name
..
4) Brand
of dietary
Name:
VITAMIN
5) Substantiation
corporate
officer
President.
Yours
ingredient(s):
See Attached
Product
Label
C COMPLEX
The
information on file at the company office.
who can certify same is Dr. Doug Metz, Vice
truly,
/txL/@Dr. Doug Metz
Vice President
.
~
8989 Rio San Diego Dr., Suite250,
San Diego, CA 921080Phone619/297-81000Fax619/209-6236
Z.z’.?z
Vitamin
C Complex
!
Description:
Vitamin C, also known as ascorbic acid, is an antioxidant that is required for proper [issue growth anti m:iin(ellancc and adrcnai glumi
function. Vitamin C supports a healthy immune system, protects against bruising, assists in blood clotting, tissue formation and the healing
of wounds. Vitamin C Complex contains ascorbic acid, four forms of ascorbatc anti citrus bioilavcsnoicis.
product is 1101in[endc~i u diagnose, trc:i~,
Thesesta~en~cn{s,havc
notbeen evaluated by he Food anLi Drug Adnli])islra[ion (FDA).‘H~iS
cure or prtvent any disease.
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VITAMIN
(
[OMP1[X
DIETARY SUP PIEHENT
Supplemcnl facls
PeI C0n12meI
Servmf Sue. 1 Tablet
- Se!vln~i
100
hn.m, P,, hmq !. 04, lx”,
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.
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VdammC (as a$cublc acd. cabum
ascmbalc,malncsmm asc~bale,
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VilamwC Complex,sIlee 01wheal(oIll
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lOOTABLETS
I’rcmlun] t’roduc/sJor Your Ileol[b 6
Wlttess
‘“
and ye351
Anwican
Spwial[y
HEAITH&VVEllNESS
October
30, 1998
Office of Special Nutritional
HFS-450 Center for Food Safety and Applied
Food and Drug Administration
Us.
200
Nutrition
c St.sw
Washington
Statement
Pursuant
Wellness
Support
DC 20204
of Nutritional
SupportVITAMIN E PLUS
to 21 CFR Part
101 .93, American
Specialty
Health
&
(ASHW) files the following Statement
of Nutritional
for the Dietary Supplement
marketed as: VITAMIN E PLUS
1) Name and Address
Ste. 250, San Diego
of Distributor:
CA 92108
ASHW
8989
Rio
San Diego
Dr.
2) Text of Nutritional
Support Statement being Made:
“Vitamin E is a fat soluble vitamin that is a powerful
protect tissue cells from damage caused
antioxidant . Antioxidants
radiation and overexposure
to the sun.
by toxic chemicals,
Vitamin E is important in the body’s cardiovascular,
immne, and
endocrine
system and the healing of wounds. Vitamin E works
closely with zinc and other antioxidants
to strengthen many
functions
of the body, including immunity.”
3)
Name
of dietary
-,
4) Brand
Name:
VITAMIN
Substantiation
corporate
officer
President.
5)
Yours
ingredient(s)
E PLUS
Information
on
who can certify
: See Attached
Product
Label
‘
file
at the
company
office.
same is Dr. Doug Metz, Vice
truly,
Xntqjl’
Dr - Doug Metz
Vice President
8989 Rio San Diego Dr., Suite 250,San Diego, CA 92108*Phone619/297-8100*Fax619/209-6236
The
Vitamin
E Plus
Description:
Vitamin E is a fat-soluble vitamin that is a powerful antioxidant. Antioxidants protect tissue cells from damage caused
toxic chemicals, radiation and overexposure to the sun. Vitamin E is importan[ in the body’s carcliovascular, immune, and cnciocrinc
system and the healing of wounds. Vitamin E works closely with zinc and other antioxidants to strengthen many functions of the body,
including immunity, Vitamin E Plus also contains the mineral selenium.
These statements have not been evaluated by the Food and Drug Administration
cure or prevent any disease.
(FDA). This product is not intended to diagnose, treat,
VITAMIN
EPLUS
DIETARY SUPPLEMENT
90
/’rcmium
CAPSULES
i’rochctsjor I’ourllcahb & w\hIcss’”
American
Special[y
HEAITHMIIIE1lNES$
October
30, 1998
Office of Special Nutritional
HFS-450 Center for Food Safety and Applied
Food and Drug Administration
Us.
200
Nutrition
c St.sw
Washington
DC 20204
Stat-ement
of Nutritional
SupportASTRAGULUS EXTRACT
Pursuant
to 21 CFR Part
101 .93,
American
Specialty
Health
Wellness
(ASHW) files
the
following
Statement
of Nutritional
Support
for
the Dietary
Supplement
marketed
as:
ASTRAGULUS EXTRACT
1) Name and Address
San Diego
Ste. 250,
of Distributor:
CA 92108
ASHW
8989
&
Rio San Diego
Dr.
2) Text
of Nutritional
Support
Statementbeing
Made:
also
known as milk–vetech
root
is considered
a
“Ast_ragulus,
The
root
of
the
plant
is
used
to
support
a
general
tonic.
healthy
immune system,
promote
healing,
and counteract
fatigue.
General
tonics
such
as astragulus
are believed
to enhance
the
body’
ability
to cope
and adapt
to stressful
conditions.”
3)
Name
4)
Brand
of dietary
-.
Name:
Substantiation
corporate
officer
President.
5)
Yours
ingredient(s):
ASTRAGULUS
See Attached
Product
Label
EXTRACT
information
on
who can certify
file
at the company
office.
same is Dr. Doug Metz, Vice
The
truly,
ZY+&7 Dr. Doug Metz
Vice President
.“,~
6227
8989 Rio San Diego Dr., Suile250, San Diego, CA 92108*Phone619/297-8100*Fax619/209-6236
7
.
*
Astragalus
Extract
1
Description:
As[ragalus, also known as milk-vetch root, is considered a general tonic. The root Oftheplantisusedtosupporta IwIIL1]Y
immune system,
promotehealing
and counteract
fatigue.
Generaltonics
suchasas[ragalus
arebelieved
toenhancethe body’s ability 10 cope and adapt to
stressful
conditions.
These statements have not been evaluated by tlw Food and Drug Administra
cure or prevent any disease.
Oireclions for (l$?: lake I capsule w day
Slorage: KeepIlghlly closed
m J
cd, d~ place.
CwlimA4arnirrg: As wdh any supplement, he(b of rnedicalion,
do ncd use il while pie nanl 01Iaclalmg, CMp(ovide il 10a child
wAhout consulting a pt“ystclan,
Hola: lhis product is fegulaled by Ihe [DA as a dtelary
sup
Iemenl. II ~u have any queslions akul how )uu Ieel
whl“fe Iaking Ihls supplement, conlacl yJur physician. II you
any medication, haveany disease w illness, consull
a{e Iaking
w physician belofe lakmg ihi$ product. !Io nol slop or change
prescflbed medication wilhoul [he pxmission 01p{emphon
o! w
phySKIM.
061R18UI[0B!MRICPA W’CCL4117
MIH
u
Po601WKMo,w O!fco,9?IWW0
6 VITLMISS’”
ion (FDA). This produc Lis not in[endc(l K)ci:agnusc, treat,
Supplement Facts
ServinR SIZC I Cdpsulc - Se(vmgs PCI Co(llalllcl
ASTRAGAIUS
[XTRA(T
hmounl
PtI
hrnnf
% 08,1,
10
V,lu,
Asllagalus ed(acl (Askagalus
memb(anaceusmol,
sld 16% ashagalosides)
450mg
‘
—.
Olhcr Ingredients: Gelahn, cellulose, calcwm phosphale
hrdrous, slearic acid, magnesium slea[ale and slhcon dlol!de
DIETARY SUPPLEMENT
‘Dady Value nol eslabhshed
Asl!a~alu! [dfacl IS[l??01whcal, coIn, SOY,dwy. ;IICIO:C
slalch, sail and ~a~l.