PLANT STEROL ESTERS

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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

January 21, 2022

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

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

Plant sterol esters

Plant sterol esters
  • Glycine max
  • Gossypium herbaceum

Seed
  • Arachis hypogaea
  • Brassica napus
  • Olea europaea
  • Secale cereale
  • Triticum aestivum
  • Zea mays

Whole plant

References: Proper name: FDA 2018, EC 2002, FDA 2001; Common name: FDA 2018, EC 2002, FDA 2001; Source information: USDA 2019, EC 2002, Kerckhoffs et al. 2002, FDA 2001.

Route of administration

Oral (FDA 2018; de Jong et al. 2008; Chen et al. 2005; Davidson et al. 2001; FDA 2001; Clifton et al. 2004; Hendriks et al. 2003; Hendriks et al. 1999; Westrate and Meijer 1998)

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 oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.

Use(s) or Purpose(s)

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

0.8 - 4.8 grams of Plant sterol esters per day, including at least 80 % of Combined beta-Sitosterol, Campesterol and Stigmasterol, per day (FDA 2018; de Jong et al. 2008; Chen et al. 2005; Clifton et al. 2004; Hendriks et al. 2003; EC 2002; Kerckhoffs et al. 2002; Davidson et al. 2001; FDA 2001; Hendriks et al. 1999; Westrate and Meijer 1998).

Direction(s) for use

Take with food (FDA 2018; de Jong et al. 2008; Chen et al. 2005; Clifton et al. 2004; Hendriks et al. 2003; Davidson et al. 2001; FDA 2001; Hendriks et al. 1999; Westrate and Meijer 1998).

Duration(s) of use

No statement required.

Risk Information

Caution(s) and warning(s)

Consult a healthcare practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding.

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

Must be established in accordance with the requirements described in the Natural Health Products Regulations (NHPR).

Specifications

References Cited

References Reviewed