BLACK WALNUT - JUGLANS NIGRA

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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

April 29, 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)	Preparation(s)
Juglans nigra	Black walnut	Juglans nigra	Unripe hull	Unripe

References: Proper name: USDA 2018; Common name: USDA 2018; Source information: Mills and Bone 2005, Tilgner 1999.

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)

(Traditionally) used in Herbal Medicine (as a vermifuge/as an anthelmintic) to help expel intestinal worms (Mills and Bone 2005; Willard 1991; Grieve 1971).

Note

Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Methods of preparation: Dry, Powder, Non-Standardised Ethanolic Extracts (Dry extract, Tincture, Fluid extract)

0.65 - 2.75 grams of unripe hulls, per day (Mills and Bone 2005; Willard 1991).

Direction(s) for use

No statement required.

Duration(s) of Use

• For occasional use only.
• Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 14 days (Mills and Bone 2005; Tilgner 1999).

Risk Information

Caution(s) and warning(s)

• Consult a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.
• Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding (Gardner and McGuffin 2010; Mills and Bone 2005).

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

• Gardner ZE, McGuffin M, editors. American Herbal Products Association's Botanical Safety Handbook, 2^nd edition. Boca Raton (FL): CRC Press, Taylor & Francis Group; 2010.
• Grieve M. A Modern Herbal. Volume 2. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
• Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): ELSEVIER Churchill Livingstone; 2005.
• Tilgner S. Herbal Medicine from the Heart of the Earth. Cresswell (OR): Wise Acres Press; 1999.
• USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Last updated 2010 July 15; Accessed 2018 August 14]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
• Willard T. The Wild Rose Scientific Herbal. Calgary (AB): Wild Rose College of Natural Healing Limited; 1991.

References Reviewed

• Brinker F. Herb Contraindications and Drug Interactions, 4th edition. Sandy (OR): Eclectic Medical Publications; 2010.
• Felter HW, Lloyd JU. King's American Dispensatory. Volume 1, 18^th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
• Peirce A. The American Pharmaceutical Association Practical Guide to Natural Medicines. New York (NY): Stonesong Press, William Morrow and Company, Inc; 1999.