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1995S-0316
RPT 355
Volume 275-278
Volume 275
Cover Page, Correspondence
between CFSAN and Archer Daniels Midland Company, Notification of
the Marketing of a New Dietary Ingredient (NDI): BeneFlax Flax Lignan
Extract
Appendix
A - Chemical structure of SDG and its metabolic conversion to
enterodiol and enterolactone
Appendix
B - Selected key papers cited in this NDI notification dossier
References Published
Material
Appendix
C - BeneFlax Flax Lignan extract technical datasheet and certificate
of analysis for 3 production lots
Appendix
D - Analysis of BeneFlax Flax Lignans, flaxseed and flax meal
for FDA-NDI submission
Appendix
E - Determination of compounds present in flax lignans by LC-PDA-MS
Appendix
F - Averaged numeric values for four process lots used to graph
ratios of flax component concentrations at sequential SDG processing
steps
Appendix
G - Outside laboratory pesticides testing reports for 3 production
lots (0602081, 0602231 & 0603031) and 2 pilot lots (K0546A &
K0548A) of BeneFlax Flax Lignan extract
Appendix
H - Outside laboratory dioxins/PCB's testing reports for 3 production
lots (0602081, 0602231 & 0603031) and 3 pilot lots (K0544B,
K0546A & K0548A) of BeneFlax Flax Lignan extract
Appendix
I - Outside laboratory mycotoxins testing report for 3 production
lots of BeneFlax Flax Lignan extract
Appendix
J - Online search of FDA website on flaxseeds and flaxseed lignans
Appendix K - Medline and CAplus literature search on flaxseed lignans
safety and toxicity Published
Material
Appendix L - Summary of literature review on animal and human studies
using flaxseeds or flax lignans Published
Material
Appendix
M - Independent report on "The potential estrogenicity
of SDG flax lignan extract"
Appendix
N - Global new products database showing products containing
flax or flax lignans and commercial products containing flax ingredients
Appendix
O - FDAs letters on history of safe use of flaxseeds and flax
products
Volumes 276-277 Published
Material
Volume 278
Cover Letter
Summary
of literature on animal and human studies using flaxseeds or flax
lignans
List
of References
References Published
Material
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November 15, 2006
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