BETA-GLUCAN

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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

Date

June 3, 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

Beta-glucan

  • beta-glucan
  • beta-D-glucan
  • Avena sativa
  • Hordeum vulgare
  • Seed
  • Seed bran

Isolate

Oat beta-glucan

Avena sativa

References: Proper name: Charlton et al. 2012; EFSA 2011a,b,2010; Queenan et al. 2007; Braaten et al. 1994; Uusitupa et al. 1992; Common names: Charlton et al. 2012; EFSA 2011a,b,2010; Queenan et al. 2007; Braaten et al. 1994; Uusitupa et al. 1992; Source materials: USDA 2019a,b, Charlton et al. 2012, Queenan et al. 2007.

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)

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

2 - 10 grams of Beta-glucan, per day (Charlton et al. 2011; EFSA 2011a,b.2010; AbuMweiss et al. 2010; Queenan et al. 2007; IOM 2005; Johnston et al. 1998; Braaten et al. 1994; Torronen et al. 1992; Uusitupa et al. 1992).

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

Preserve in well-closed containers (USP 35 2012).

Specifications

References Cited

References Reviewed