Document 6471165

BURREN SPRINGSTM
75 DAY PRE-MARKET
PREMARKET
NOTIFICATION
NOTIFICATION
Extract of Garclnia Cambogia (-)-HCA
SUBMITTED
BY
BRENDAN 0’ MARA
SHANNON MINERALS LIMITED
UPPER CLARE STREET,
LIMERICK,
IRELAND
MAY 2005
SHANNON
MINERALS
Page)of114
LIMITED
BURREN SPRINGS”
75 DAY PRE-MARKET NOTIFICATION
CONTENTS
1.
NAME AND ADDRESS OF DISTRIBUTOR AND CURRENT MANUFACTURER ........... 3
NAME AND IDENTITY OF NEW DIETARY INGREDIENT .............................................
.4
DESCRIPTION OF THE PRODUCTS CONTAINING EXTRACT OF GARCINIA
~AMBOGIA, (-pcA . . ...............................................................................................................
5
4.
SHANNON MINERALS LTD (Burren Springm) QUALITY SYSTEM ............................. 11
RAW MATERIAL QUALITY 8 SELECTION ...................................................................
5.
.20
HISTORY OF USE I SAFETY EVIDENCE ....................................................................
.25
6.
DESIGNATED SIGNATORY ..........................................................................................
7.
.28
APPENDIX A: BACKGROUND AND HISTORY OF USE ......................................................
.29
APPENDIX B: SAFETY & TOXICOLOGY.. ............................................................................
.75
APPENDIX C: MECHANISMS OF ACTION ...........................................................................
.81
2.
SHANNON
MINERALS
Page2of113
LIMITED
BURREN SPRINGSTM
75 DAY PRE-MARKET NOTIFICATION
1.
NAME AND ADDRESS OF DISTRIBUTOR
MANUFACTURER
AND CURRENT
Distributor:
Mr. David Tourville,
Shannon Minerals Inc
26 Washington Street
3rd Floor
Morristown
NJ 07960
Tel : I-973-267-6980
Fax: 1-973-267-6981
Email: [email protected]
GMP Manufacturer:
Sabinsa Corporation
70 Ethel Road West, Suite 6
Piscataway, NJ 06854, USA
Tel:+l-732-777-1’111
Fax: + I-732-777-1 443
E-mail: [email protected]
GMP BOTTLER/PACKAGER
Shannon Minerals. Limited
Upper Clare Street,
Limerick ,
Ireland.
Tel:
Fax
E-Mail
+35361418068
+35361418179
&[email protected]
SHANNON
MINERALS
Page3of113
or willie@&hannonminerals.ie
LIMITED
BURREN SPRINGSw
75 DAY PRE-MARKET NOTIFICATION
2.
NAME AND IDENTITY OF NEW DIETARY INGREDIENT
Chemical Name:
(2S3S) -2- Hydroxycitric Acid
Other Name:
Extract of Garcinia Cambogia, (-) - Hydroxycitric Acid
Common Name
(-) HCA, (-) -Hydroxycitrate
(See also (-) - Hydroxycitric Acid - The principal Acid in the fruits of Garcinia Cambogia
Desr., Lewis and Neelakantan, Central Food Technological Research Institute, Mysore, India,
March 1964) - (Appendix A)
COMPARISON
OF DIFFERENT SOURCES OF (-)-HCA
Examples of such salts are; Citrin@ by SabinsaTMa Calcium salt, Citrin K BG@ by Sabinsa,TM
a Potassium Salt, Citrimax@ by InterHealth NeutraceuticalsTM a Calcium salt, SuperCitrimax@
by InterHealth Neutraceuticals-TMa Potassium /Calcium Salt.
-..y-.
_.I.
. . . . “,.V
Loss on drying 8%
Solubility in water >99%
PH (1 g/100 ml water) 6.0 - 9.0
(-)-Hydroxycitric acid 600*50 mg/g
Calcium 1 IO*30 mg/g
Potassium 160+_40mglg
Sodium <IO mg/g
Phytosterols 0.5 mg/g
Total protein 3 mg/g
Soluble dietary fiber (by difference) 8.5%
Moisture 4.5%
Microbial standards
Total plate count ~3000 CFlJlg
Yeast and mold cl 0 CFU/g
Escherichia coli Negative
Salmonella Negative
Staphylococcus aureus Negative
Heavy metals
Lead cl0 ppm
Cadmium ~0.25 ppm
Cadmium ~0.25 ppm
Arsenic cl0 ppm
Mercury co.25 ppm
Total Heavy Metals n/a
_..I...
. .
IVU
n/a
>99%
6.0 - 8.5
500 mg/g
n/a
280 mglg
n/a
n/a
nla
n/a
5%
< 5000 CFUlg
c 100 CFU/g
Negative
Negative
Negative
c 10 ppm
n/a
n/a
c 1 pm
n/a
c= 20 ppm
J
SABINSA CITRIN K BG@
Citrin K BG@ has been granted a Certificate Of Free Sale within the USA and for export.
See attached copy in APPENDIX
B: Safety and Toxicology, Certificate of Free Sale.
SHANNON
MINERALS
Page4of113
LIMITED
BURREN SPRINGSTM
75 DAY PRE-MARKET
NOTIFICATION
3.
DESCRIPTION OF THE PRODUCTS CONTAINING
EXTRACT OF GARCINIA CAMBOGIA, (-)-HCA.
CONDITIONS
PROCESSING
OF USE:
AND METHOD
BASIS FOR CONCLUSION
SUPPLEMENT
OF MANUFACTURING
THAT THIS DIETARY
INGREDIENT
CONFIDENTIAL
Page5of
113
IS A NEW DIETARY
BURREN
SPRINGSTM
75 DAY PRE-MARKET
NOTIFICATION
DESCRIPTION OF THE PRODUCTS CONTAINING
3.
EXTRACT OF GARCINIA CAMBOGIA, (-)-HCA.
CONDITIONS
OF USE:
-3
PROCESSING
AND METHOD
OF MANUFACTURING
CONFIDENTIAL
SHANNON
MINERALS
Page6of114
LIMITED
BURREN
SPRINGSTM
75 DAY PRE-MARKET
PROCESSING
Manufacturing
NOTIFICATION
AND METHOD OF MANUFACTURING
Citrin K@
Process
MAMJFACTURING
FLOW CHART
CONFIDENTIAL
SHANNON
MINERALS
Page7of114
LIMITED
BURREN SPRINGSTM
75 DAY PRE-MARKET
Botsuicnl
NOTIFICATION
Sane:
Prodnct:
SouIxe:
C‘ontninr:
i-1 Hydroxydric
acid
2S-31°0 elementnl Potassium
C’hernktry:
* b of Active
Ingredient:
&Sob (-) Hyb~ozycitric
acid - Lxtone
500 mg of ezrract (750 mg HC4) 30 minutes
1 hour before menls - 3 times clnily.
Dose:
Toxicity
datx
Srttrnceotical
I-2.
Jlinimum
Apptic~tions:
Mnrketiag
For-m of Supply:
History
Appetite snpprerwnt
Liver cholerterol
rynthesir
iuhibitor
I-PS
Standmdized
solulde
SHANNON
Powdered
MINERALS
Extract.
LIMITED
Page 8 of 114
water
to
free
BURREN SPRINGSTM
75 DAY PRE-MARKET
REF. TEST METHOD:
NOTIFICATION
SI-P-0415-0-I
SHANNON
MINERALS
LIMITED
Page 9 of 114
BURREN
SPRINGSTM
75 DAY PRE-MARKET
l3PL.C 1IETHOD
FOR ESTIlIzA.TIOX
NOTIFICATION
OF HI-DROSI-
CONFIDENTIAL
SHANNON
MINERALS
LIMITED
Page IO of 114
CITRIC’ ACID
upperctarestreet
Limerick.
MINERALS
Ireland
ii?
+353 (0161 418068
‘:’
r3.53 (0)61 418179
! E ! Info~shannonmineratz.ie
v-W wwwhannoominerats
HPLC METHOD FOR ESTIMATION
OF K-HCA
ie
BURREN
SPRINGSTM
75 DAY PRE-MARKET
QUALITY
AND MANUFACTURING
NOTIFICATION
PROCESS
FOR Burren Spring
CONFIDENTIAL
SHANNON
MINERALS
LIMITED
TM