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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 statements are synonymous. Either term or statement may be selected by the applicant.

Date

July 1, 2019

Proper name(s), Common name(s), Source material(s)

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source material(s)
Proper name(s) Part(s) Preparation

Glycine max

  • Defatted soybean flour1
  • Defatted soy flour1
  • Soybean Flour
  • Soy Flour

Glycine max

Seed

Dried

References: Proper name: USDA 2019; Common names: USDA 2019, Tomar and Shiao 2008; Source material: USDA 2019, Tomar and Shiao 2008.

1Defatted flour refers to preparations where the oil has been removed.

Route of Administration

Oral

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

  • 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 (Wang et al. 2013; Liu et al. 2005).
  • Source of protein (for the maintenance of good health) (CFIA 2016).
  • Source of protein which helps build and repair body tissues (CFIA 2016).
  • Source of (an) (non-essential) amino acid(s) involved in muscle protein synthesis (IOM 2005).
  • Source of (an) (essential) amino acid(s) involved in muscle protein synthesis (IOM 2005).
  • Source of (an) essential amino acid(s) for the maintenance of good health (IOM 2005).

The following combined use(s) or purpose(s) is/are also acceptable:

Source of (an) essential amino acid(s) involved in muscle protein synthesis and for the maintenance of good health (IOM 2005).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Antioxidant

Methods of preparation: Powder; Defatted, ground

Not to exceed 8 grams of soy flour, per day (Tomar and Shiao 2008; Travis et al. 2008).

Source of Protein

Methods of preparation: Defatted, ground

5.5 - 8 grams of defatted soy flour, per day (CNF 2015; Travis et al. 2008; IOM 2005).

Method of preparation: Powder

7.5 - 8 grams of soy flour, per day (CNF 2015; Travis et al. 2008; IOM 2005).

Source of (essential) amino acid(s) involved in muscle protein synthesis/for the maintenance of good health

Methods of preparation: Defatted, ground

5.5 - 8 grams of defatted soy flour, per day (CNF 2015; Travis et al. 2008; IOM 2005).

Method of preparation: Powder

7.5 - 8 grams of soy flour, per day (CNF 2015; Travis et al. 2008; IOM 2005).

OR

Method of preparation: Standardized Powder

Essential amino acids Minimum dose of amino acid (milligrams/day)1 Maximum dose of Soy flour or Defatted soy flour (grams/day)2

Histidine

49 mg

8 g

Isoleucine

66.5 mg

Leucine

147 mg

Lysine

133 mg

Methionine

66.5 mg

Phenylalanine

115.5 mg

Threonine

70 mg

Tryptophan

17.5 mg

Valine

84 mg

1Minimum doses have been calculated as 5% of each specific amino acid Recommended Dietary Allowance with a reference weight of 70 kg (IOM 2005).

2Maximum dose (CNF 2015; Tomar and Shiao 2008; Travis et al. 2008; IOM 2005).

Source of (non-essential) amino acids involved in muscle protein synthesis

Methods of preparation: Defatted, ground

5.5 - 8 grams of defatted soy flour, per day (CNF 2015; Travis et al. 2008; IOM 2005).

Method of preparation: Powder

7.5 - 8 grams of soy flour, per day (CNF 2015; Travis et al. 2008; IOM 2005).

OR

Method of preparation: Standardized Powder

Non-Essential amino acids Minimum dose of amino acid (milligrams/day)1 Maximum dose of Soy flour or Defatted soy flour (grams/day)2

Alanine

181.5 mg

8 g

Arginine

208.5 mg

Aspartic acid

325 mg

Glutamic acid

750 mg

Glycine

160 mg

Proline

259.5 mg

Serine

175.5 mg

Tyrosine

139 mg

1Minimum doses have been calculated as 5% of each specific amino acid Mean Intake with a reference weight of 70 kg (IOM 2005).

2Maximum dose (CNF 2015; Tomar and Shiao 2008; Travis et al. 2008; IOM 2005).

Direction(s) for use

No statement required.

Duration(s) 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.

Non-medicinal ingredients

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

Storage conditions

No statement required.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.

References Cited

  • CNF 2015: Canadian Nutrient File. Canadian Nutrient File, Ottawa (ON): Food and Nutrition, Health Canada. [Accessed 2019 May 27]. Available from: https://food-nutrition.canada.ca/cnf-fce/switchlocale.do?lang=en&url=t.search.recherche
  • CFIA 2016: Canadian Food Inspection Agency. Food Labelling for Industry, Ottawa (ON): Canadian Food Inspection Agency and Health Canada. Internet. [Accessed 2019 June 17]. Available from:
  • http://www.inspection.gc.ca/food/requirements/labelling/industry/eng/1383607266489/1383607344939
  • IOM 2005: 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, [Accessed 2019 June 3]. Available from: https://www.nal.usda.gov/sites/default/files/fnic_uploads/energy_full_report.pdf
  • 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 2019: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [Internet]. 2006. Glycine max (L). Merr. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2019 May 27]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysimple.aspx
  • 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.