What is it used for?
(Traditionally) used in Herbal Medicine to help relieve the pain associated with menstruation (Hoffmann 2003, Blumenthal et al. 2000, Bradley 1992, Williamson et al. 1988, Ellingwood 1983, Felter and Lloyd 1983).
(Traditionally) used in Herbal Medicine to help relieve muscle and joint pain associated with rheumatic conditions (such as rheumatoid arthritis, osteoarthritis and/or fibrositis), and pain associated with neuralgia (such as sciatica) (Hoffmann 2003, BHP 1983, Ellingwood 1983, Felter and Lloyd 1983).
(Traditionally) used in Herbal Medicine (as a calmative) to help ease nervous tension (Hoffmann 2003, Williamson 2003, BHP 1983, Ellingwood 1983, Felter and Lloyd 1983)
Used in Herbal Medicine to help relieve premenstrual symptoms (Blumenthal et al. 2000, Bradley 1992).
(Used in Herbal Medicine to) help(s) relieve symptoms associated with menopause (EMA 2018; Raus et al. 2006, Wuttke et al. 2006, Frei-Kleiner et al. 2005, Blumenthal et al. 2000, Bradley 1992).
The above uses can be combined on the product label if from the same traditional or non-traditional system of medicine (e.g., Traditionally used in Herbal Medicine to help relieve muscle and join pain associated with rheumatic conditions, pain associated with neuralgia, and to help ease nervous tension).
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 active ingredient(s) 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. Black cohosh is traditionally used in Herbal Medicine to help ease nervous tension).
When ALL of the active ingredients (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.
What this guide covers
Text in parentheses is additional optional information which can be included on 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 on the label.
Who does this guide cover?
Adults 18 years and older
How is it taken?
Oral
Which forms are covered?
this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.
Quantities
Methods of preparation: Dry, Powdered, Non-Standardised Extracts (Dry extract*, Tincture, Fluid Extract, Decoction, Decoction concentrate, Infusion, Infusion concentrate)
40 - 2,400 milligrams of dried root and/or rhizome, per day [Source note 2].
*Note: Solvents allowed for the method of preparation “Non-standardized extracts (Dry extract)” as part of this reference are ethanol and/or water only.
How is it used?
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
How long is it used?
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
Warnings and precautions
Ask a healthcare professional if symptoms persist or worsen.
Ask a healthcare professional before use if you are breastfeeding.
Ask a healthcare professional before use if you have a liver disorder or develop symptoms of liver trouble [Source note 3].
When should it be avoided?
Do not use if you are pregnant [Source note 4].
Possible side effects
The reference does not require an additional label statement in this section. This does not establish an absence of risk.
Storage
Must be established in accordance with the requirements described in the applicable product regulations.
Preparation details
Ingredient identity, preparation requirements, and other details that define the scope of this guide.
Ingredients and preparations
| Proper name(s) | Common name(s) | Source information / Source material(s) | Source information / Part(s) | Source information / Preparation(s) |
|---|---|---|---|---|
| Actaea racemosa |
| Actaea racemosa |
| Dry |
References: Proper name: USDA 2024; Common names: Gardner and McGuffin 2013; Source information: BHP 1996.
Other ingredients
Must be chosen from the current source ingredient database and must meet the limitations outlined in the database.
Preparation and quality requirements
The finished product specifications must be established in accordance with the requirements described in the source authority source’s product quality guidance.
The active ingredient must comply with the requirements outlined in the source ingredient database.
source authority is aware of peer-reviewed published cases where products labelled as containing Black Cohosh were found by laboratory analysis to contain different species. In order to prevent misidentification, the identification of authentic Black Cohosh must be completed by an unambiguous validated method such as the HPLC-ELSD, HPLC-MS or HPLC-MS/MS to determine the presence of a specific marker compound and/or the absence of others. For example, Actaea racemosa contains the triterpene glycoside cimiracemoside C (also called cimigenol-3-Oarabinoside), while most other Actaea/Cimicifuga species do not; conversely, other Actaea/Cimicifuga species contain the phenolic acid derivatives cimifugin and (or) cimifigin-3-O-glucoside (e.g. A. cimicifuga and A. yunnanensis, but not A. dahurica) while Black Cohosh does not. The commonly used markers, 23-epi-26deoxyactein and actein, are found in more than one species of Actaea and therefore their presence is not sufficient evidence alone of the unambiguous identification of Actaea racemosa [Source note 5]. The source authority recognizes that there are numerous methods which can be used to unambiguously identify Black Cohosh. These methods include, but are not limited to, those cited in the following references: Avula et al. 2007; He et al. 2006; Jiang et al. 2006; Brigham et al. 2004; Zerega et al. 2002; He et al. 2000.
Note: Data relating to the identification of Black Cohosh, using an unambiguous validated method, is not to be submitted with the reference-based product documentation, although it may be requested at the source authority's discretion.
Guide change history
Updates to this SupplementSafety.org guide.
Minor updates
Updated guide wording, organization, and source presentation. Added our editorial change history.
Initial release
Initial SupplementSafety.org guide prepared from source reference material.
Validation: Not yet completed. Editorial updates do not constitute clinical validation.
Sources
Source information
This guide organizes source material about uses, preparations, amounts, and precautions. Read the conditions alongside each statement; the information may apply only to particular preparations or populations.
The source document includes supporting references. We have not independently summarized or assessed every cited study for this guide.
- Source document version
- January 31, 2025
- Source captured
- Aug 15, 2026
- Editorial work
- Editorial preparation. Independent clinical review has not been recorded for this guide.
Full citations are available through the link above. Verification is required to open them; reading this guide does not require verification.
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