ACAI – EUTERPE OLERACEA

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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

Date

December 29, 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) Preparation(s)
Euterpe oleracea
  • Acai
  • Açai
  • Assai palm
  • Cabbage palm
Euterpe oleracea
  • Fruit flesh
  • Fruit juice
Dry

References: Proper name: USDA 2023, McGuffin et al. 2000; Common names: USDA 2023, derMarderosian and Beutler 2008, McGuffin et al. 2000, Mors et al. 2000; Source information: Schreckinger et al. 2010, Schauss et al. 2006, Lichtenthäler et al. 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)

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Methods of preparation: Dry, Powder, Non-Standardized Extracts (Dry extract*, Tincture, Fluid Extract, Decoction, Infusion)

Not to exceed 14 grams of dried fruit flesh or dried fruit juice, per day (Tonon et al. 2010; Facciola et al. 1998).

*Note: Solvents allowed for the method of preparation "Non-standardized extracts (Dry extract)" as part of this monograph are ethanol and/or water only.

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are pregnant or breastfeeding (derMarderosian and Beutler 2008).

Contraindication(s)

No statement required.

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (derMarderosian and Beutler 2008).

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

EXAMPLE OF PRODUCT FACTS:

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

Product Facts Table

References Cited

References Reviewed