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Drugs and Health Products

Soy Flour

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Date

December 8, 2015

Proper Name(s), Common Name(s) and Source Material(s)

Table 1: Proper name(s), common name(s) and source material(s)
Proper name(s)1 Common name(s)1,2 Source material(s)1,2

Table 1 Footnotes

Table 1 Footnote 1

USDA 2006

Return to Table 1 footnote1 referrer

Table 1 Footnote 2

Tomar and Shiao 2008

Return to Table 1 footnote2 referrer

Table 1 Footnote 3

Defatted flour refers to preparations where the oil has been removed.

Return to Table 1 footnote3 referrer

Glycine max (L.) Merr. Soy flour
Soybean flour
Seed (Bean)
Glycine max (L.) Merr. Defatted soy flour3
Defatted soybean flour3
Seed (Bean)

Route(s) of Administration

Oral

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums, beverages or bulk flour intended for food preparation.

Use(s) or Purpose(s)

Statement(s) to the effect of
All products
  • Source of antioxidants/Provides antioxidants (Wang et al. 2013; Liu et al. 2005).
  • Source of antioxidants/Provides antioxidants that help fight/protect (cell) against/reduce (the oxidative effect of/the oxidative damage caused by/cell damage caused by) free radicals (Wange et al. 2013; Liu et al. 2005).
  • Source of (an) (essential) amino acid(s) involved in muscle protein synthesis (IOM 2002)*.
  • Source of (an) essential amino acid(s) for the maintenance of good health (IOM 2002)*.
Note:
For these claims, individual amino acid quantities must be indicated on the PLA in the "Activity" section and on the label.
Products containing defatted soy flour
  • Source of protein (for the maintenance of good health) (CFIA 2012).
  • Source of protein which helps build and repair body tissues (CFIA 2012).

Dose

Statement(s) to the effect of

Sub population

Adults (≥ 18 years)

Quantity

Antioxidant
Powder, defatted, ground

Up to 8 g soy flour per day (Tomar and Shiao 2008; Travis et al. 2008).

Source of Protein: Defatted soy flour only
Powder, defatted, ground

5.5 — 8 g defatted soy flour per day (CNF 2010; Travis et al. 2008; IOM 2002)

Source of Amino acid(s)
As per the doses indicated in the Natural and Non-prescription Health Products Directorate (NNHPD) Workout Supplement monograph.

Directions for use

No statement required.

Duration of Use

No statement required.

Risk Information

Caution(s) and Warning(s)

No statement required.

Contraindication(s)

No statement required.

Known Adverse Reaction(s)

No statement required.

Storage Condition(s)

No statement required.

Non Medicinal Ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.

References Cited

CNF 2010: Canadian Nutrient File. Next link will take you to another Web site Canadian Nutrient File, Ottawa (ON): Food and Nutrition, Health Canada. TEXT3. [Date Modified 2012 April 26; Accessed 2014 September 15].

CFIA 2012: Canadian Food Inspection Agency. Next link will take you to another Web site Food Labelling for Industry, Ottawa (ON): Canadian Food Inspection Agency and Health Canada. Internet. [Date modified 2013 July 22].

IOM 2002: Institute of Medicine of the National Academies. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Food and Nutrition Board, Institute of Medicine. Washington (DC): National Academy Press; 2002.

Liu J, Chang SK, Wiesenborn D. Antioxidant properties of soybean isoflavone extract and tofu in vitro and in vivo. Journal of Agricultural and Food Chemistry 2005;53(6):2333-40.

Tomar RS, Shiao R. Early life and adult exposure to isoflavones and breast cancer risk. Journal of Environmental Science and Health. Part C, Environmental Carcinogenesis & Ecotoxicology Reviews 2008;26(2):113-173.

Travis RC, Allen NE, Appleby PN, Spencer EA, Roddam AW, Key TJ. A prospective study of vegetarianism and isoflavone intake in relation to breast cancer in British women. International Journal of Cancer 2008;122:705-10.

USDA 2006: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Next link will take you to another Web site Germplasm Resources Information Network (GRIN) . [Internet]. 2006. Glycine max (L) Merr. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2014 September 16].

Wang Q, Ge X, Tian X, Zhang Y, Zhang J, Zhang P. Soy isoflavone : The multipurpose phytochemical (Review). Biomedical Reports 2013;1(5):697-701.

References Reviewed

Cederroth CR, Auger J, Zimmermann C, Eustache F, Nef S. Soy, phyto-oestrogens and male reproductive function: a review. International Journal of Andrology 2010;33(2):304-16.

Chavarro JE, Toth TL, Sadio SM, Hauser R. Soy food and isoflavone intake in relation to semen quality parameters among men from an infertility clinic. Human Reproduction 2008;23:2584-2590

Doerge DR. Bioavailability of soy isoflavones through placental/lactational transfer and soy food. Toxicology and Applied Pharmacology 2011;254(2):145-

Wang H-J, Murphy PA. Mass balance study of isoflavones during soybean processing. Journal of Agricultural and Food Chemistry 1996;44(8):2377-2383.

Yu C, Tai F, Zeng S, Zhang X. Effects of perinatal daidzein exposure on subsequent behavior and central estrogen ? expression in the adult male mouse. Progress in Neuro-Psychopharmacology and Biological Psychiatry 2013;43:157-167.