CALIFORNIA POPPY - ESCHSCHOLZIA CALIFORNICA

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

(PDF Version - 64.7 KB)

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 26, 2024

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
Proper name(s)	Common name(s)	Source material(s)	Part(s)	Preparation(s)
Eschscholzia californica	California poppy	Eschscholzia californica	Herb top	Dry

References: Proper name: USDA 2023; Common name: McGuffin et al. 2000; Source information: Mills and Bone 2005, Hoffmann 2003.

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 to help relieve restlessness and/or nervousness (calmative) (Mills and Bone 2005; Hoffmann 2003; Felter and Lloyd 1983).
(Traditionally) used in Herbal Medicine as a sleep aid (during times of mental stress) (Mills and Bone 2005; Hoffmann 2003; Felter and Lloyd 1983).
Traditionally used in Herbal Medicine as an analgesic (Mills and Bone 2005; Hoffmann 2003; Felter and Lloyd 1983).

Notes:

The above claims can be combined on the product label if from the same traditional system of medicine e.g. Traditionally used in Herbal Medicine to help relieve restlessness and/or nervousness and as a sleep aid during time of mental stress.
For multi-ingredient products:

To prevent the product from being represented as a "traditional medicine," any indicated traditional use claim must refer to the specific medicinal ingredient(s) (MI) and recognized traditional system of medicine from which the claim originates when 1) both traditional and modern claims are present or 2) when claims originate from multiple systems of traditional medicine (e.g. California poppy is traditionally used in Herbal Medicine to help relieve restlessness and/or nervousness).
When ALL of the MIs in the product are used within the SAME identified system of traditional medicine AND the product makes ONLY traditional claims, listing of MIs in the traditional claim(s) is not required.

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)

0.2 - 3 grams of dried herb top, per day (Mills and Bone 2005; Hoffmann 2003)

*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

Sleep aid

Take (1 hour) before bedtime, as needed.

Other uses

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Sleep aid

Ask a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists continuously for more than 4 weeks (chronic insomnia) (Berardi et al. 2002; Dipiro et al. 2002).

Other uses

Ask a health care practitioner/health care provider/health care professional/doctor/physician if symptoms persist or worsen.

All products

Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are breastfeeding (Brinker 2010; Mills and Bone 2005).
When using this product avoid taking with alcohol or products that cause drowsiness and/or with analgesic properties (Brinker 2010; Mills and Bone 2005; Hoffmann 2003).
When using this product exercise caution if you drive or use machinery as you may experience drowsiness (EMA 2015; Berardi et al. 2002).

Contraindication(s)

Do not use if you are pregnant (Brinker 2010; Blumenthal et al. 2000).

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.

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.

EXAMPLE OF PRODUCT FACTS:

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

Product Facts Table

References Cited

Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13^th edition. Washington (DC): American Pharmaceutical Association; 2002.

Blumenthal M, Goldberg A, Brinkmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.

Brinker F. Herb Contraindications and Drug Interactions, 4^th edition. Sandy (OR): Eclectic Medical Publications; 2010.

Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy: a pathophysiologic approach, 5^th edition. New York (NY): The McGraw-Hill Companies, Inc.; 2002.

EMA 2015: European Medicines Agency. European Union herbal monograph on Eschscholzia californica Cham., herba London. (UK): Committee on Herbal Medicinal Products (HMPC); 2015. [Accessed 2024 March 1]. Available from: https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-eschscholzia-californica-cham-herba_en.pdf.

Felter HW, Lloyd JU. King's American Dispensatory, Volume 2, 18^th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].

Hoffmann D. Medical Herbalism. Rochester (VT): Healing Arts Press; 2003.

McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.

Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.

USDA 2023: United States Department of Agriculture Agricultural Research Service (USDA ARS), Germplasm Resources Information Network (GRIN) - Global. U.S. National Plant Germplasm System. [Accessed 2023 September 11]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysearch

References Reviewed

McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press; 1997.

Moore M. Medicinal Plants of the Pacific West. Santa Fe (NM): Red Crane Books, Inc.; 1993.

Sayre LE. A Manual of Organic Materia Medica and Pharmacognosy. Philadelphia (PA): P. Blakiston's Son & Co.; 1917.