CITRUS BIOFLAVONOIDS

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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

• Text in parentheses is additional optional information which can be included on the PLA and product 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.

Date

March 31, 2023

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)
Citrus bioflavonoids	Citrus bioflavonoids	Citrus aurantiifolia Citrus limon Citrus paradisi Citrus reticulata Citrus sinensis	Fruit Fruit peel

References: Proper name: Burdock 2005; Common name: Burdock 2005; Source information: USDA 2019a,b,c,d, Nogata et al. 2006, Burdock 2005.

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/Provides antioxidants (Jung et al. 2003; Manthey et al. 2001).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Not to exceed 600 milligrams of Citrus bioflavonoids, per day (USDA 2013; Chun et al. 2007; Burbock et al. 2005; Blostein-Fujii et al. 1999).

Note
Must not exceed 600 milligrams of Citrus bioflavonoids, per day, when combined with other bioflavonoids such as but not limited to, quercetin, hesperidin, rutin, etc.

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Products providing 50 milligrams or more of Citrus bioflavonoids, per day

Consult a healthcare practitioner/health care provider/health care professional/doctor/physician prior to use if you are taking prescription medication as citrus bioflavonoids may alter the effectiveness of these medications (Brinker 2018).

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

• 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.

References Cited

• Blostein-Fujii A, DiSilvestro RA, Frid D, Katz C. Short term citrus flavonoid supplementation of type II diabetic women: no effect on lipoprotein oxidation tendencies. Free Radical Research 1999;30(4):315-320.
• Brinker 2018: Brinker F. Final updates and additions for Herb Contraindications and Drug Interactions, 4th edition, including extensive Appendices addressing common problematic conditions, medications and nutritional supplements, and influences on Phase I, II & III metabolism with new appendix on botanicals as complementary adjuncts with drugs. [Internet]. Sandy (OR): Eclectic Medical Publications. [Accessed 2019 May 14]. Available from: https://www.eclecticherb.com/herb-contraindications-drug-interactions
• Burdock G.A. Fenaroli's Handbook of Flavor Ingredients, 5^th ed. CRC Press; 2005.
• Chun OK, Chung SJ, Song WO. Estimated dietary flavonoid intake and major food sources of
• U.S. adults. Journal of Nutrition 2007;137(5):1244-1252.
• Jung UJ, Kim HJ, Lee JS, Lee MK, Kim HO, Park EJ, Kim HK, Jeong TS, Choi MS. Naringin supplementation lowers plasma lipids and enhances erythrocyte antioxidant enzyme activities in hypercholesterolemic subjects. Clinical Nutrition 2003;22(6):561-568.
• Manthey JA, Guthrie N, Grohmann K. Biological Properties of Citrus Flavonoids Pertaining to Cancer and Inflmmation. Current Medicinal Chemistry 2001;8(2):135-153.
• Nogata Y, Sakamoto K, Shiratsuchi H, Ishii T, Yano M, Ohta H. Flavonoid composition of fruit tissues of citrus species. Bioscience Biotechnology and Biochemistry 2006;70(1):178-192.
• USDA 2019a: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. Citrus reticulata Blanco. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 May 14]. Available from: https://npgsweb.arsgrin.gov/gringlobal/taxon/taxonomysimple.aspx
• USDA 2019b: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. Citrus sinensis (L.) Osbeck. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 May 14]. Available from: https://npgsweb.arsgrin.gov/gringlobal/taxon/taxonomysimple.aspx
• USDA 2019c: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. Citrus limon (L.) Burm.f. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 May 14]. Available from: https://npgsweb.arsgrin.gov/gringlobal/taxon/taxonomysimple.aspx
• USDA 2019d: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). [Internet]. Citrus aurantiifolia (Christm.) Swingle. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2019 May 14]. Available from: https://npgsweb.arsgrin.gov/gringlobal/taxon/taxonomysimple.aspx
• USDA 2013. USDA Database for selected Flavonoid Content of Selected Foods. Release 3.1. Prepared by S Bhagwat, DB Haytowitz, JM Holden. Nutrient Data Laboratory, Betsville Human Nutrition Research Center, Agriculture Research Service, U.S. Department or Agriculture; June 2013. [Accessed 2019 May 14]. Available from: http://www.ars.usda.gov/SP2UserFiles/Place/12354500/Data/Flav/Flav3-1.pdf

References Reviewed

• Ameer B, Weintraub RA, Johnson JV, Yost RA, Rouseff RL. Flavanone absorption after naringin, hesperidin, and citrus administration. Clinical Pharmacology and Therapeutics 1996;60(1):34-40.
• CNF 2013: Canadian Nutrient File, Food and Nutrition, Health Canada. [Accessed 2013 August 06] Available from: http://www.hc-sc.gc.ca/fn-an/nutrition/fiche-nutri-data/index-eng.php
• Linus Pauling 2009. Jane Higdon, and Roderick H. Dashwood. Copyright 2005-2009 Linus Pauling Institute. [Accessed 2013 August 06]. Available from: http://lpi.oregonstate.edu/infocenter/phytochemicals/flavonoids/