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Monograph: Ginseng, American

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. Note: Text in parentheses is additional optional information which can be included on the PLA form and product label at the applicants' discretion. The solidus (/) indicates that the terms and or/statements are synonymous. Either term or statement may be selected by the applicant.

Date: 2015-07-06

NHPID Name

Panax quinquefolius (USDA 2008)

Proper Name(s)

Panax quinquefolius L. (Araliaceae) ( USDA 2005 )

Common Name(s)

American ginseng ( USDA 2005 , McGuffin et al. 2000 )

Source Material

Root ( PPRC 2015 , Lust 1974 , Wren 1956 )
Panax quinquefolius is an endangered plant in the wild; thus only the roots from cultivated plants are acceptable source material (EC 2009). See Specifications for further details.

Route Of Administration

Oral

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph 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:

Dose(s)

Adults:

Glucose levels; Mild sedative; Nervousness; Immune System
Preparation: Dry, Powder, Decoction, & Infusion, extract dry, extract liquid, tincture, fluid extract

Dose(s): 0.5 - 12 Grams per day, dried root
TCM
Preparation: Decoction

Dose(s): 2.4 - 9 Grams per day, dried root
Directions For Use: Prepare dried root as a decoction (PRC 2005)

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):

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).
  • Proof of sale or permit must be available for possession of the cultivated Panax quinquefolius because the wildlife species is endangered: (i) Panax quinquefolius is protected under the federal Species at Risk Act (SARA). Under section 32(2) of this Act, no person shall possess, collect, buy, sell or trade an individual of a wildlife species that is listed as an extirpated species, an endangered species or a threatened species, or any part or derivative of such an individual (JC 2015), (ii) Panax quinquefolius is protected by the Quebec Act Respecting Threatened or Vulnerable Species. Under this Act, it is prohibited to possess, trade, or harm this species, or to disturb its habitat (EC 2015).
  • The medicinal ingredient may comply with the specifications outlined in the American Ginseng, Powdered American Ginseng monographs published in the U.S. Pharmacopoeia (USP 38).

References cited

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