Monograph: Plant Stanol Esters

Date: 2022-01-21

NHPID name

Plant stanol esters ( US Govt Printing Office 2009 )

Proper name(s)

Common name(s)

Plant Stanol Esters

Source material

Route Of administration

Oral ( Chen et al. 2005 , de Jong et al. 2008 , FDA 2000 , FDA 2009 , Goldberg et al. 2006 , Hallikainen et al. 2008 )

Dosage form(s)

The acceptable pharmaceutical dosage forms suited to oral administration include, but are not limited to, chewables (e.g. gummies, tablets), caplets, capsules, strips, lozenges, powders or liquids where the dose is measured in drops, teaspoons or tablespoons. This labelling standard is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or purpose(s)

Statement(s) to the effect of:

• Helps maintain healthy cholesterol levels.  (FDA 2009, Hallikainen et al. 2008, de Jong et al. 2008, Goldberg et al. 2006, Chen et al. 2005, FDA 2000)
• Helps lower blood total and LDL cholesterol.  (FDA 2009, Hallikainen et al. 2008, de Jong et al. 2008, Goldberg et al. 2006, Chen et al. 2005, FDA 2000)

Dose(s)

Duration of use

No statement is required

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): Consult a health care practitioner prior to use if you are pregnant or breastfeeding. Contraindication(s): No statement is required Known Adverse Reaction(s): No statement is required

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database 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 NHPD Quality of natural health products guide.
• The medicinal ingredient must comply with the requirements outlined in the Natural health products ingredient database (NHPID).