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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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