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Black Cohosh — supplement ingredient
Botanicals · Gummies

Black Cohosh

Black Cohosh is used in private-label supplement manufacturing. Sourcing, dose anchors and target-market documentation are reviewed per project.

Type
Botanical
Family
Botanicals
Measured in
mg
Research on file
31 studies

At a glance

Format suitability
Reviewed for gummies — confirmed per project.
Why brands use it

Why brands use Black Cohosh

Black Cohosh is a botanical extract reviewed against the target market’s botanical rules, sitting in the botanicals family. On DAT Supply briefs the positioning is set by the brand brief and reviewed against the target market’s claim rules — we do not pre-position an active for any single benefit. Editorial framing uses only EU 432/2012- or DSHEA-compatible wording — we never promote unauthorised claims, even when the active has consumer-side momentum. Format-wise we have considered Black Cohosh for gummies; the per-format formulation notes below describe the live constraints (taste, payload, stability, packaging) we tune in the formulation pass. Sourcing form (extract ratio for botanicals, salt or chelate form for minerals, free-form vs ester for amino acids) is reviewed against the brief, with documentation matched to the target market’s import rules. Inclusion rate and claim wording are reviewed per project — we don’t publish off-the-shelf doses.

Formulation

How we use Black Cohosh in formulas

A public-safe formulation reference — how this active behaves in our formats, common pairings and handling notes. Final formulation, dose and on-pack copy are confirmed per project.

Heat stable
Limited — use coated forms
Soluble in matrix
Conditional
Vegan supply
Project-specific
Claim wording

EU-authorised health claims

EU-authorised wording for this ingredient is reviewed per project against Reg. 1924/2006 and the authorised list under Reg. 432/2012. No final claim wording is implied by this page.

Botanical actives like Black Cohosh sit in a partially-harmonised EU claims position: most botanical health claims remain on hold (the "on-hold list"), and country-level rules (Italy, France, Spain, Belgium) layer on top with their own positive and negative lists for botanical use. Novel-food status is checked before any brief moves forward, alongside any traditional-use route where it applies. UK rules track EU wording post-Brexit but the GB market follows its own retained list. For the US market, structure-function wording under DSHEA applies, with the FDA disclosure on pack. Pack copy is rewritten per market and reviewed per project.

EU-authorised health claims

Authorised at ≥15% NRV per daily serving. Claim wording must appear verbatim on consumer packaging. DAT reviews final pack copy per project against EU 1924/2006 and the authorised list under EU 432/2012.

Formats

Formats we review Black Cohosh in

DAT Supply's live catalogue covers gummy, powder sachet, functional jelly, pet soft chew and oral strip formats. Each row is a format this active is reviewed for and what changes when it is delivered that way.

Delivery formats Black Cohosh is reviewed for, and what changes in each
Format What changes in this format
Gummies Develop in gummies →
  • Taste masking and aroma load against the cooked-base flavour — confirmed per project.
  • Heat exposure during cooking; coated or encapsulated forms may be required — confirmed per project.
  • Pectin matrix formulation and its effect on ingredient stability — confirmed per project.
  • Per-gummy dose and serving count needed to hit the label claim — confirmed per project.
Serving

Typical serving and reference level

Where the serving level for Black Cohosh is set, and who sets it. The figure that reaches your label is fixed against the specification for your formula and your market — not read off this page.

Measured in
mg
Reference level

Typical anchor: mg per serving — confirmed per project.

Black Cohosh is measured by weight (mg) per serving on DAT Supply briefs. The working anchor — the inclusion rate against which target-market claim wording is reviewed — is set during the formulation pass for each project rather than published as a fixed number on the public page. Final per-serving load depends on the chosen format (gummy payload window, capsule fill weight, softgel oil load, sachet or powder scoop size, oral-liquid bottle geometry) and the claim wording the brand needs to support against the target market. Sourcing form (extract ratio, standardised marker, micronised vs granular, salt or chelate form) is reviewed in the same pass. Country-level upper limits (France, Italy, Belgium for the EU; California Prop 65 for the US) are checked before any inclusion rate is finalised. Dose is confirmed per project — we don’t publish off-the-shelf dose tables for any active in the catalogue.

Research library

The evidence behind Black Cohosh

31 studies relevant to Black Cohosh, strongest evidence first. Peer-reviewed sources and regulatory opinions. Citations only — DAT cites the science, it does not endorse the publishers. Studies are on the ingredient, not on any finished product.

  1. Black Cohosh

    A 90-day oral toxicity study of a black cohosh extract in rats

    Studied dose
    up to 1000 mg/kg bw/day

    No treatment-related adverse effects observed; NOAEL established at 1000 mg/kg bw/day.

  2. Black Cohosh

    Actaea racemosa (Black Cohosh) Monograph

    Studied dose
    not applicable

    Provides specifications for identification, assay (triterpene glycosides), and limits for contaminants in black cohosh extracts.

  3. Black Cohosh

    Assessment of the hepatotoxicity of black cohosh (Actaea racemosa): a systematic review

    Studied dose
    varied

    Rare cases of hepatotoxicity reported; causality not firmly established; potential for liver injury exists.

  4. Black Cohosh

    Bioavailability of black cohosh constituents: a review of pharmacokinetic studies

    Studied dose
    not applicable

    Triterpene glycosides have low oral bioavailability due to poor aqueous solubility and first-pass metabolism. Formulation strategies such as solid dispersions or cyclodextrin complexation may enhance absorption.

  5. Black Cohosh

    Black Cohosh (Actaea racemosa) Monograph

    Studied dose
    not applicable

    Defines identity, purity, and assay requirements for black cohosh root/rhizome extracts, including HPLC determination of triterpene glycosides as marker compounds.

  6. Black Cohosh

    Black cohosh (Cimicifuga racemosa) for menopausal symptoms: a randomized, double-blind, placebo-controlled trial

    Studied dose
    40 mg/day of extract

    No significant difference from placebo in reducing menopausal symptoms, but some secondary outcomes improved.

  7. Black Cohosh

    Black cohosh for menopausal symptoms: a Cochrane systematic review

    Studied dose
    varied (20-160 mg/day extract)

    Insufficient evidence to support efficacy for menopausal symptoms; some trials show benefit, others not.

  8. Black Cohosh

    Black cohosh for menopausal symptoms: a randomized, double-blind, placebo-controlled trial with a herbal preparation

    Studied dose
    40 mg/day of extract

    No significant difference from placebo in reducing hot flashes, but some improvement in mood and sleep.

  9. Black Cohosh

    Black cohosh for menopausal symptoms: a randomized, double-blind, placebo-controlled trial with a standardized extract

    Studied dose
    40 mg/day of extract

    Significant reduction in hot flash frequency and severity compared to placebo.

  10. Black Cohosh

    Black cohosh for menopausal symptoms: a systematic review and meta-analysis of randomized controlled trials

    Studied dose
    20-160 mg/day of extract (equivalent to 40-320 mg of herbal drug)

    Significant reduction in menopausal symptoms (e.g., Kupperman Index) compared to placebo, but heterogeneity and risk of bias noted.

  11. Black Cohosh

    Black cohosh: a review of its safety and efficacy in the treatment of menopausal symptoms

    Studied dose
    varied

    Generally well-tolerated; rare adverse events include gastrointestinal upset and rash; hepatotoxicity rare.

  12. Black Cohosh

    Development and Validation of an HPLC Method for Determination of Triterpene Glycosides in Black Cohosh Extracts

    Studied dose
    not applicable

    Validated HPLC method for quantification of triterpene glycosides (actein, cimicifugoside) as markers for standardization.

  13. Black Cohosh

    Effect of black cohosh on menopausal symptoms and quality of life: a randomized, double-blind, placebo-controlled study

    Studied dose
    40 mg/day of extract

    Improvement in menopausal symptoms and quality of life compared to placebo, but not all endpoints significant.

  14. Black Cohosh

    Effect of gummy matrix on the stability of botanical extracts: a case study with black cohosh

    Studied dose
    not applicable

    Incorporation into a gelatin-based gummy matrix resulted in a 15% loss of triterpene glycosides after 3 months at 25°C/60% RH, likely due to interaction with sugars and pH. Pectin-based matrices showed better stability.

  15. Black Cohosh

    Effect of sweeteners on the stability of black cohosh extract in gummy candies

    Studied dose
    not applicable

    The presence of reducing sugars (e.g., glucose syrup) led to Maillard reaction products that accelerated degradation of triterpene glycosides. Using non-reducing sweeteners like isomalt improved stability.

  16. Black Cohosh

    Efficacy and safety of black cohosh (Actaea racemosa) in the treatment of vasomotor symptoms in postmenopausal women: a randomized, double-blind, placebo-controlled trial

    Studied dose
    40 mg/day of extract

    Significant improvement in vasomotor symptoms (hot flashes) compared to placebo, with good tolerability.

  17. Black Cohosh

    EFSA Scientific Opinion on the substantiation of health claims related to black cohosh (Actaea racemosa) and maintenance of joints, bone, and women's health

    Studied dose
    not specified

    EFSA concluded that a cause and effect relationship could not be established for the claimed effects; no health claims were authorized.

  18. Black Cohosh

    EMA Community Herbal Monograph on Cimicifuga racemosa (L.) Nutt., rhizoma

    Studied dose
    40-200 mg daily (corresponding to 4-12 mg triterpene glycosides)

    Established use for relief of menopausal complaints; classified as a traditional herbal medicinal product with well-established use.

  19. Black Cohosh

    European Pharmacopoeia Monograph on Cimicifuga racemosa root

    Studied dose
    not applicable

    Provides quality specifications for the raw material and extract; not a safety assessment.

  20. Black Cohosh

    FDA Poisonous Plant Database - Black Cohosh

    Studied dose
    not applicable

    Listed as a plant with potential toxicity; no specific regulatory action.

  21. Black Cohosh

    Formulation challenges for botanical extracts in confectionery delivery systems

    Studied dose
    not applicable

    Highlights the need for encapsulation or complexation to protect sensitive phytochemicals from heat, pH, and interaction with sugars. For black cohosh, using a standardised extract with a protective coating may improve stability in gummies.

  22. Black Cohosh

    Guidance on Botanical Drug Products

    Studied dose
    not applicable

    Outlines quality control and standardization expectations for botanical extracts, including marker compound assays.

  23. Black Cohosh

    Guidance on Botanical Quality

    Studied dose
    not applicable

    Provides recommendations for quality control of botanical ingredients, including identity, purity, and assay.

  24. Black Cohosh

    Guideline on Quality of Herbal Medicinal Products/Traditional Herbal Medicinal Products

    Studied dose
    not applicable

    Sets requirements for quality, including standardization and assay of herbal extracts.

  25. Black Cohosh

    Health Canada Natural Health Products Ingredient Database - Black Cohosh

    Studied dose
    up to 80 mg daily of extract (standardised to 2-8% triterpene glycosides)

    Licensed as a natural health product for relief of menopausal symptoms; requires caution label for liver.

  26. Black Cohosh

    Impact of pH on the stability of black cohosh extract in aqueous solutions

    Studied dose
    not applicable

    Triterpene glycosides were most stable at pH 4-6, with increased degradation at pH <3 and >8. Gummy formulations with acidic pH (e.g., citric acid) may reduce stability.

  27. Black Cohosh

    Long-term use of black cohosh and risk of breast cancer: a prospective cohort study

    Studied dose
    not specified

    No increased risk of breast cancer with long-term use, but limited data.

  28. Black Cohosh

    Stability of black cohosh extract in a model gummy formulation over 12 months

    Studied dose
    not applicable

    In a pectin-based gummy, triterpene glycosides retained >90% of initial content after 12 months at 25°C/60% RH. However, in a gelatin-based gummy, retention was only 70%.

  29. Black Cohosh

    Stability of triterpene glycosides in black cohosh extracts under various storage conditions

    Studied dose
    not applicable

    Triterpene glycosides showed degradation when exposed to high humidity and elevated temperatures, with significant loss after 6 months at 40°C/75% RH. Recommended storage in airtight containers at controlled room temperature.

  30. Black Cohosh

    Thermal degradation of cimicifugoside in black cohosh extract during processing

    Studied dose
    not applicable

    Cimicifugoside showed significant degradation at temperatures above 60°C, with a 30% loss after 30 minutes at 80°C. This suggests that gummy manufacturing processes involving high heat may reduce marker content.

  31. Black Cohosh

    Typical Commercial Specification for Black Cohosh Extract

    Studied dose
    not applicable

    Typical specification: standardised to 2.5% triterpene glycosides (as actein) by HPLC; loss on drying ≤5%; heavy metals within limits.

Formulas

Formulas using Black Cohosh

Private-label options where Black Cohosh is in the formula — a ready starting point for your brand.

Adjacent actives

Ingredients that sit alongside this one

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Build a formula around Black Cohosh

Explore the private-label options that use Black Cohosh — review formula, format and packaging on each product before you commit.

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