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Drugs and Health Products

Plant Sterol Esters

This abbreviated labelling standard is intended to serve as a guide to industry for the preparation of a Product Licence Applications (PLAs) and labels for natural health product market authorization. It includes generalized claims and is not intended to be a comprehensive review of the medicinal ingredient. Wording of the claim on the PLA and label must therefore be identical to this labelling standard.

Date

2009-10-15

NHPID Name

  • Plant sterol esters (US Govt Printing Office 2009)
  • Phytosterols (Natural Standard 2009)

Proper Name(s)

Plant sterol esters ( FDA 2009 , European Commission 2002 , FDA 2000 )

Common Name(s)

Plant sterol esters ( FDA 2009 , European Commission 2002 , FDA 2000 )

Source Material(s)

  • Arachis hypogaea (Whole) (USDA 2008, European Commission 2002, Kerckhoffs et al. 2002, FDA 2000)
  • Brassica napus (Whole) (USDA 2008, European Commission 2002, Kerckhoffs et al. 2002, FDA 2000)
  • Glycine max (Seed) (USDA 2008, European Commission 2002, Kerckhoffs et al. 2002, FDA 2000)
  • Gossypium herbaceum (Seed) (USDA 2008, European Commission 2002, Kerckhoffs et al. 2002, FDA 2000)
  • Olea europaea (Whole) (USDA 2008, European Commission 2002, Kerckhoffs et al. 2002, FDA 2000)
  • Secale cereale (Whole) (USDA 2008, European Commission 2002, Kerckhoffs et al. 2002, FDA 2000)
  • Triticum aestivum (Whole) (USDA 2008, European Commission 2002, Kerckhoffs et al. 2002, FDA 2000)
  • Zea mays (Whole) (USDA 2008, European Commission 2002, Kerckhoffs et al. 2002, FDA 2000)

Route(s) of Administration

Oral ( Chen et al. 2005 , Clifton et al. 2004 , Davidson et al. 2001 , de Jong et al. 2008 , FDA 2000 , FDA 2009 , Hendriks et al. 2003 , Hendriks et al. 1999 , Westrate and Meijer 1998 )

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 lower blood total and LDL cholesterol (FDA 2009, de Jong et al. 2008, Chen et al. 2005, Clifton et al. 2004, Hendriks et al. 2003, Davidson et al. 2001, FDA 2000, Hendriks et al. 1999, Westrate and Meijer 1998)
  • Helps maintain healthy cholesterol levels (FDA 2009, de Jong et al. 2008, Chen et al. 2005, Clifton et al. 2004, Hendriks et al. 2003, Davidson et al. 2001, FDA 2000, Hendriks et al. 1999, Westrate and Meijer 1998)

Dose(s)

Adults:

Dose(s): 0.8 - 4.8 Grams per day including at least 80 Percent Combined beta-Sitosterol, Campesterol and Stigmasterol per day (FDA 2009, de Jong et al. 2008, Chen et al. 2005, Clifton et al. 2004, Hendriks et al. 2003, European Commission 2002, Kerckhoffs et al. 2002, Davidson et al. 2001, FDA 2000, Hendriks et al. 1999, Westrate and Meijer 1998)

Directions For Use: With food (FDA 2009, de Jong et al. 2008, Chen et al. 2005, Clifton et al. 2004, Hendriks et al. 2003, Davidson et al. 2001, FDA 2000, Hendriks et al. 1999, Westrate and Meijer 1998)

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 (NHPID) and must meet the limitations outlined in the database.

Specifications

A Finished Product Specifications Form must accompany the application. The product must comply with the requirements of the most recent published version of the "Evidence for Quality of Finished Natural Health Products" guidance document.

References Cited

  • Chen JT, Wesley R, Shamburek RD, Pucino F, Csako G. 2005. Meta-Analysis of Natural Therapies for Hyperlipidemia Plant Sterols and Stanols versus Policosanol for Hyperlipidemia. Pharmacotherapy. 25: 171-183.
  • Clifton PM, Noakes M, Sullivan D, Erichsen N, Ross D, Annison G, Fassoulakis A, Cehun M, Nestel P. 2004. Cholesterol-lowering effects of plant sterol esters differ in milk, yoghurt, bread and cereal. European journal of clinical nutrition. 58: 503-509.
  • Davidson, MH, Maki KC, Umporowicz DM, Ingram KA, Dicklin MR, Schaefer E, Lane RW, McNamara JR, Ribaya-Mercado JD, Perrone G, Robins SJ, Franke WC. Safety and Tolerability of Esterified Phytosterols Administered in Reduced-Fat Spread and Salad Dressing to Healthy Adult Men and Women. 2001 Journal of the American College of Nutrition. 20: 307-319.
  • de Jong A, Plat J, Bast A, Godschalk RW, Basu S, Mensink RP. Eur J Clin Nutr. Effects of plant sterol and stanol ester consumption on lipid metabolism, antioxidant status and markers of oxidative stress, endothelial function and low-grade inflammation in patients on current statin treatment. 2008 Feb;62(2):263-73
  • European Commission. 2002. General view of the Scientific Committee on Food on the long-term effects of the intake of elevated levels of phytosterols from multiple dietary sources, with particular attention to the effects on beta-carotene. Health & Consumer Protection Directorate-General. http://ec.europa.eu/food/fs/sc/scf/out143_en.pdf [Accessed on October 14, 2009]
  • FDA (Food and Drug Administration) October 2009. 101.83 Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD). http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=b39601aa6d95670faf7f0c388a191312&rgn=div8&view=text&node=21:2.0.1.1.2.5.1.15&idno=21 [Accessed October 14, 2009]
  • FDA. (Food and Drug Administration), HHS. 2000. Food labeling: health claims; plant sterol/stanol esters and coronary heart disease. Interim final rule; notice of extension of period for issuance of final rule. Federal Register. 66(109):30311-3.
  • Hendriks HF, Brink EJ, Meijer GW, Princen HM, Ntanios FY. 2003. Safety of long-term consumption of plant sterol esters-enriched spread. European journal of clinical nutrition. 57: 681-692.
  • Hendriks HFJ, Weststrate JA, Vliet T, Meijer GW. 1999. Spreads enriched with three different levels of vegetable oil sterols and the degree of cholesterol lowering in normocholesterolaemic and mildly hypercholesterolaemic subjects. European journal of clinical nutrition. 53:319-327.
  • Kerckhoffs DA, Brouns F, Hornstra G, Mensink RP. Effects on the human serum lipoprotein profile of beta-glucan, soy protein and isoflavones, plant sterols and stanols, garlic and tocotrienols. J Nutr. 2002 Sep;132(9):2494-505.
  • USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • Westrate JA, Meijer GW. 1998. Plant sterol-enriched margarines and reduction of plasma total- and LDL-cholesterol concentrations in normocholesterolaemic and mildly hypercholesterolaemic subjects. European journal of clinical nutrition. 52:334-343.

References Reviewed

  • Goldberg AC, Ostlund RE Jr, Bateman JH, Schimmoeller L, McPherson TB, Spilburg CA. Effect of plant stanol tablets on low-density lipoprotein cholesterol lowering in patients on statin drugs. Am J Cardiol. 2006 Feb 1;97(3):376-9.
  • Hallikainen M, Lyyra-Laitinen T, Laitinen T, Moilanen L, Miettinen TA, Gylling H. Effects of plant stanol esters on serum cholesterol concentrations, relative markers of cholesterol metabolism and endothelial function in type 1 diabetes. Atherosclerosis. 2008 Aug;199(2):432-9.
  • JOINT FAO/WHO EXPERT COMMITTEE ON FOOD ADDITIVES Sixty-ninth meeting Rome, Italy, 17-26 June 2008 SUMMARY AND CONCLUSIONS issued 4 July 2008 http://www.who.int/ipcs/food/jecfa/summaries/summary69.pdf
  • Lau VW, Journoud M, Jones PJ. Plant sterols are efficacious in lowering plasma LDL and non-HDL cholesterol in hypercholesterolemic type 2 diabetic and nondiabetic persons. American Journal of Clinical Nutrition. 2005 81:1351-8.
  • Thomsen AB, Hansen HB, Christiansen C, Green H, Berger A. Effect of free plant sterols in low-fat milk on serum lipid profile in hypercholesterolemic subjects. Eur J Clin Nutr. 2004 Jun;58(6):860-70.