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Drugs and Health Products


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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.


  • 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.


August 28, 2018

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

References: Proper name: USDA 2018, McGuffin et al. 2000; Common names: NS 2018, USDA 2018, 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


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 (Mertens-Talcott et al. 2008; Schauss et al. 2006; Lichtenthäler et al. 2005).
  • Source of/Provides antioxidants that help fight/protect (cell) against/reduce (the oxidative effect of/the oxidative damage caused by/cell damage caused by) free radicals (Mertens-Talcott et al. 2008; Schauss et al. 2006, Lichtenthäler et al. 2005).



Adults 18 years and older


Methods of preparation: Dry, Powder, Non-Standardised 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).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding (NS 2018; derMarderosian and Beutler 2008).


No statement required.

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (NS 2018; 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 (NHPR).


  • 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

  • derMarderosian A, Beutler JA, editors. The Review of Natural Products. [Acai: Date of issue January 2008]. St Louis (MO): Facts and Comparisons, Wolters Kluwer Health; Printed in 2008 and Updated to April 2012.
  • Faccolia S. Cornucopia II A source book of edible plants. Vista (CA): Kampong Publications; 1998.
  • Lichtenthäler R, Rodrigues RB, Maia JG, Papagiannopoulos M, Fabricius H, Marx F. Total oxidant scavenging capacities of Euterpe oleracea Mart. (Açaí) fruits. International Journal of Food Sciences And Nutrition 2005;56(1):53-64.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
  • Mertens-Talcott SU, Rios J, Jilma-Stohlawetz P, Pacheco-Palencia LA, Meibohm B, Talcott ST, Derendorf H. Pharmacokinetics of anthocyanins and antioxidant effects after the consumption of anthocyanin-rich açai juice and pulp (Euterpe oleracea Mart.) in human healthy volunteers. Journal of Agriculture and Food Chemistry 2008;56(17):7796-7802.
  • Mors WB, Toledo Rizzini C, Alvares Pereira N, Defilipps RA. Medicinal Plants of Brazil. Algonac (MI): Reference Publications Inc.; 2000.
  • NS 2018: Natural Standard: The Authority on Integrative Medicine. Acai (Euterpe oleracea) Natural Standard Professional Monograph, Copyright © 2018 [Internet]. [Accessed 2018 June 29. Available from:
  • Schauss AG, Wu X, Prior RL, Ou B, Huang D, Owens J, Agarwal A, Jensen GS, Hart AN, Shanbrom E. Antioxidant capacity and other bioactivities of the freeze-dried Amazonian palm berry, Euterpe oleraceae mart. (açai). Journal of Agriculture and Food Chemistry 2006;54(22):8604-8610.
  • Schreckinger ME, Lotton J, Lila MA, Gonzalez de Mejia E. Berries from South America: a comprehensive review on chemistry, health potential, and commercialization. Journal of Medicinal Food 2010;233-246.
  • Tonon RV, Brabet C, Hubinger MD. Anthocyanin stability and antioxidant activity of spray-dried açai (Euterpe oleracea Mart.) juice produced with different carrier agents. Food Research International 2010;43(3):907-914.
  • USDA 2018: USDA ARS, National Genetic Resources Program. Germplasm Resources
  • Information Network (GRIN) [Internet]. National Germplasm Resources Laboratory, Beltsville: (MD). [Accessed 2018 June 15]. Available from: ttp://

References Reviewed

  • Duke JA, Vazquez Martinez R. Amazonian Ethnobotanical Dictionary. Boca Raton (FL): CRC Press; 1994.
  • Important Information about Acai Berry Products containing Prescription Medication. Ottawa (ON): Marketed Health Products Directorate. Date Modified 2010 January 15; [Accessed 2012 January 20]. Available from:
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association’s Botanical Safety Handbook. Boca Raton (FL): CRC Press; 1997.
  • Pozo-Insfran DD, Brenes CH, Talcott St. Phytochemical composition and pigment stability of açai (Euterpe oleracea Mart.). Journal of Agriculture and Food Chemistry 2004;52(6):1539-1545.
  • Rocha APM, Carvalho LCRM, Sousa MAV, Madeira SVF, Sousa PJC, Tano T, Schini-Kerth VB, Resende AC, Soares de Moura R. Endothelium-dependent vasodilator effect of Euterpe oleracea Mart. (Açaí) extracts in mesenteric vascular bed of the rat. Vascular Pharmacology 2007;46:97-104.
  • Sosnowska J, Balslev H. American palm ethnomedicine: a meta-analysis. Journal of Ethnobiology and Ethnomedicine 2009;5:43