Inulin

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 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 on the label.

Date

September 27, 2024

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)
Inulin	Inulin	Cichorium intybus	Root
		Helianthus tuberosus	Tuber

References: Proper name: CFIA 2016; IOM 2005; Common name: CFIA 2016; IOM 2005; Source information: USDA 2024; CFIA 2016; IOM 2005; Gardner and McGuffin 2013.

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 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)

• Source of fiber for the maintenance of good health (FCC 2023; CFIA 2016; IOM 2005).
• Helps support and maintain a healthy digestive system (FCC 2023; CFIA 2016; IOM 2005).
• Helps stimulate the growth of healthy bacteria (such as bifidobateria) in the intestine/gut (Marteau et al. 2011; Roberfroid 2007a; Menne et al. 2000; Gibson et al. 1995).
• Prebiotic (Marteau et al. 2011; Ramnani 2010; Roberfroid 2007a,b; Menne et al. 2000; Gibson et al. 1995).
• Helps provide gentle relief of constipation and/or irregularity (Marteau et al. 2011; IOM 2005; Kleessen et al. 1997).

Notes:

• The above uses can be combined on the product label (e.g. Prebiotic which helps stimulate the growth of healthy bacteria (such as bifidobacteria) in the intestine/gut).
• The terms 'Helps' or 'Helps to' can be used interchangeably on the label.

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)¹

All products

2-15 grams of Inulin, per day (Kolida and Gibson 2007; IOM 2005; Menne et al. 2000; Coussement 1999).

¹Note: Inulin preparations containing 90% or more inulin are acceptable, provided the quantity of inulin listed on the PLA form and label represents the inulin content only.

Direction(s) for use

Products providing 5 g or more of Inulin, per dose

• Take with at least 250 ml of liquid (Pray 2006).
• Take a few hours before or after taking other medications or health products (Pray 2006).

For powder dosage forms

Mix well with liquid and drink immediately (Pray 2006).

Optional

Take during the day (not immediately prior to bedtime) (Sweetman 2007).

Duration(s) of use

No statement required.

Risk information

Caution(s) and warning(s)

Products for constipation/irregularity

Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms worsen or if laxative effect does not occur within 7 days (Pray 2006).

Products providing 5 g or more of Inulin, per dose

Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have diabetes (Pray 2006).

Contraindication(s)

Products for constipation/irregularity

Do not use if you have fever or any undiagnosed gastrointestinal trouble (HC 2009).

Known adverse reaction(s)

All products

Stop use if hypersensitivity/allergy occurs (Brinker 2010; Hendler and Rorvik 2008; Franck et al. 2005; Gay-Crosier et al. 2000).

Products providing 5 g or more of Inulin, per day

When using this product you may experience temporary gas and bloating (Marteau et al. 2011; Kolida and Gibson 2007; Menne et al. 2000; Coussement 1999; Klessen et al. 1997).

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.

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.

Example of product facts

Consult the Guidance Document, Labelling of Natural Health Products for more details.

References cited

• Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
• CFIA 2016: Canadian Food Inspection Agency, Food Labelling for Industry, Chapter 6: Elements Within the Nutrition Facts Table Section 6.8.1 Dietary Fibre. [Accessed 2019 June 26]. Available from: http://www.inspection.gc.ca/food/requirements-and-guidance/labelling/industry/eng/1383607266489/1383607344939
• Coussement PAA 1999. Inulin and Oligofructose: safe intakes and legal status. The Journal of Nutrition 1999;129:1412S-1417S.
• FCC 8: Food Chemicals Codex. Eighth edition. Rockville (MD): The United States Pharmacopeial Convention; 2012.
• Franck P, Moneret-Vautrin DA, Morisset M, Kanny G, Mégret-Gabeaux ML, Olivier JL. Anaphylactic reaction to inulin : first identification of specific IgEs to an inulin protein compound. International Archives of Allergy and Immunology 2005;136:155-158.
• Gardner Z. and McGuffin M. editors. American Herbal Products Association's Botanical Safety Handbook, 2nd edition. American Herbal Products Association. Boca Raton (FL): CRC Press; 2013.
• Gay-Crosier F, Schreiber G, Huaser C. Anaphylaxis from inulin in vegetables and processed food. The New England Journal of Medicine 2000;342(18):1372.
• Gibson GR, Beatty ER, Wang X, Cummings JH. Selective stimulation of bifidobacteria in the human colon by oligofructose and inulin. Gastroenterology 1995;108(4):975-82.
• HC 2009: Laxatives: General - Laxatives - Labelling Standard. Ottawa (ON): Drugs and Health Products; Health Canada. [Accessed 2024 January 6]. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/nonprescription-drugs-labelling-standards/laxatives-labelling-standards-non-prescription-drugs.html
• 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 26]. Available from: https://www.nap.edu/read/10490/chapter/12#680
• Kleessen B, Sykura B, Zunft H-J, Blaut M. Effects of inulin and lactose on fecal microflora, microbial activity, and bowel habit in elderly constipated persons. American Journal of Clinical Nutrition 1997;65(5):1397-1402.
• Kolida S, Gibson GR. 2007. Prebiotic capacity of inulin-type fructans. The Journal of Nutrition 2007;137:2503S-2506S.
• Marteau P, Jacobs H, Cazaubiel M, Signoret C, Prevel J-M, Housez B. Effects of chicory inulin in constipated elderly people: a double-blind controlled trial. International of Food Sciences and Nutrition 2011;62(2):164-170.
• Menne E, Guggenbuhl, Roberfroid M. Fn-type chicory inulin hydrolysate has a prebiotic effect in humans. Journal of Nutrition 2000;130:1197-1199.
• Pray WS. Non-Prescription Product Therapeutics, 2nd edition. New York (NY): Lippincott Williams & Wilkins; 2006.
• Ramnani P, Gaudier E, Bingham M, van Bruggen P, Tuohy KM, Gibson GR. Prebiotic effect of fruit and vegetable shots containing Jerusalem artichoke inulin: a human intervention study. British Journal of Nutrition 2010;104(2):233-240.
• Roberfroid MB. Inulin-type fructans: functional food ingredients. The Journal of Nutrition 2007a;137:2493S-2502S.
• Roberfroid M. Prebiotics: The Concept Revisited. The Journal of Nutrition 2007b;137:830S-837S.
• Sweetman SC, editor. 2007. Martindale: The Complete Drug Reference, 35th edition. London (GB): Pharmaceutical Press.
• USDA 2024: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) - Global. U.S. National Plant Germplasm System. [Accessed 2024 January 6]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysearch

References reviewed

• BHC 1992: Bradley PR, editor. British Herbal Compendium Volume 1: A Handbook of Scientific Information on Widely Used Plant Drugs—Companion to Volume 1 of the British Herbal Pharmaocopeia. Bournemouth (GB): British Herbal Medicine Association; 1992.
• Brighenti F, Casiraghi MC, Canzi E, Ferrari A. Effect of consumption of a ready-to-eat breakfast cereal containing inulin on the intestinal milieu and blood lipids in healthy male volunteers. European Journal of Clinical Nutrition 1999;53(9):726-33.
• Causey JL, Feirtag JM, Gallaher DD, Tungland BC, Slavin JL. Effects of dietary inulin on serum lipids, blood glucose and the gastrointestinal environment in hypercholesterolemic men. Nutrition Research 2000;20:191-201.
• Den Hond E, Geypens B, Ghoos Y. Effect of high performance chicory inulin on constipation. Nutrition Research 2000;20(5):731-736.
• ESCOP 2003: E/S/C/O/P Monographs: The Scientific Foundation for Herbal Medicinal Products. 2nd edition. Exeter (GB): ESCOP, the European Scientific Cooperative on Phytotherapy in collaboration with Georg Thieme Verlag and Thieme; 2003.
• Kim SH, Lee DH, Meyer D, Supplementation of infant formula with native inulin has a prebiotic effect in formula-fed babies. Asia Pacific Journal of Clinical Nutrition 2007;16(1):172-177.
• Pourghassem GB, Dehghan P, Aliasgharzadeh A, Asghari J-AM. Effects of high performance inulin supplementation on glycemic control and antioxidant status in women with type 2 diabetes. Diabetes Metabolism Journal 2013;37(2):140-148.
• Rao AV. Dose-Response effects of inulin and oligofructose on intestinal bifidogenesis effects. Journal of Nutrition 1999;129:1442S-1445S.
• Roberfroid MB, Van Loo JAE, Gibson GR. The bifidogenic nature of chicory inulin and its hydrolysis products journal of nutrition 1998;128:11-19.
• Szajewska H, Wizman Z, Abu-Zekry M, Kekez A, Braegger C, Kolacek S, Micetic-Turk D, Ruszczynski M, Vukavic T. Inulin and fructo-oligosaccharides for the prevention of antibiotic-associated diarrhea in children: report by the ESPHGAN working group on probiotics and prebiotics. Journal of Pediatric Gastroenterology and Nutrition 2012;54(6):828-829.
• Van Dokkum W, Wezendonk B, Srikumar TS, van den Heuvel EGHM. Effect of nondigestible oligosaccharides on large-bowel functions, blood lipid concentrations and glucose absorption in young healthy male subjects. European Journal of Clinical Nutrition 1999;53(1):1-7.
• Yap WKW, Mohamed S, Jamal MH, Meyer D, Manap YA. Changes in infant faecal characteristics and microbiota by inulin supplementation. Journal of Clinical Biochemistry Nutrition 2008;43:159-166.
• WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CH): World Health Organization; 1999.