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Botanicals · Gummies

Black Cohosh

INCI: Actaea racemosa

Black Cohosh (Actaea racemosa) is a botanical extract from the root of a North American perennial plant, traditionally used in herbal wellness practices. In private-label gummy manufacturing, it is positioned for women's health and hormonal balance during menopause. As a botanical on the EFSA on-hold list, it carries no authorised EU health claims under Reg. (EU) 432/2012.

  • women's health, hormonal balance, menopause support
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Black Cohosh

At a glance

Definition
Black Cohosh (Actaea racemosa) is a botanical extract from the root of a North American perennial plant, traditionally used in herbal wellness practices. In private-label gummy manufacturing, it is positioned for women's health and hormonal balance during menopause. As a botanical on the EFSA on-hold list, it carries no authorised EU health claims under Reg. (EU) 432/2012.
Authorised wording (summary)
2 authorised statements — see "US structure-function statements" below.
Common positionings
  • Menopause comfort
  • Hot flash relief
  • Night sweat management
  • Mood balance during menopause
  • Hormonal transition support
Format suitability
Reviewed for gummies and sachets — confirmed per project.
Format & category fit

Where this ingredient fits in the DAT Supply catalogue

Every format chip links through to its manufacturing hub and to the private-label catalogue for that format. The category chip routes to the matching vertical hub on the categories index.

Positioning

What it is

Black Cohosh (Actaea racemosa) is a botanical extract derived from the root of a perennial plant native to eastern North America. It has been used in traditional herbal wellness practices for generations, particularly in the context of women's health during the menopausal transition. In modern nutraceutical manufacturing, Black Cohosh is typically supplied as a dried root extract standardised to triterpene glycosides, the active marker compounds.

Brands choose Black Cohosh for gummy formats because it addresses a well-defined consumer need — menopause comfort and hormonal balance — in a category that remains underserved in gummy form. The ingredient's strong consumer recognition, combined with its compatibility with gummy processing, makes it a commercially viable addition to women's health ranges. DAT Supply works with suppliers who provide standardised extracts suitable for gummy and sachet formats.

Origin and history

Black Cohosh has a documented history of traditional use among Native American tribes, who used the root for various wellness purposes. European settlers adopted the plant into their herbal practices, and by the 19th century it was listed in the United States Pharmacopeia. Its common name derives from the dark colour of the dried root, and "cohosh" is an Algonquian word meaning "rough" or "bumpy," referring to the root's appearance.

Today, commercial Black Cohosh is primarily wild-crafted or cultivated in the Appalachian region of the United States. Industrial production involves harvesting the root after three to five years of growth, drying, and extracting with ethanol or water to produce a standardised extract. The extract is then spray-dried into a powder suitable for encapsulation, tableting, or incorporation into gummy formulations.

Scientific overview

The primary active constituents in Black Cohosh are triterpene glycosides, including actein and cimifugoside. These compounds are believed to interact with serotonin receptors and modulate neurotransmitter activity, which may contribute to the ingredient's traditional use for temperature regulation and mood balance during menopause. Unlike soy isoflavones, Black Cohosh does not appear to have direct oestrogenic activity, which distinguishes its mechanism from phytoestrogen-based botanicals.

Bioavailability of triterpene glycosides from oral administration is considered moderate. Standardisation of extracts to a consistent percentage of triterpene glycosides (typically 2.5% to 5%) is important for batch-to-batch reproducibility. The powdered extract is heat-stable and soluble in gummy processing, though the bitter taste requires careful flavour masking with fruit-forward profiles such as berry or pomegranate.

Manufacturing watchpoints include the potential for hepatotoxicity in rare cases, which has led to regulatory caution in some markets. DAT Supply reviews supplier documentation for heavy metal testing, microbial limits, and solvent residues per project. The cost-per-mg is mid-tier, making Black Cohosh suitable for gummy formulations where the target dose of 40 mg to 160 mg per serving is achievable within reasonable raw material cost.

Why brands use Black Cohosh

Black Cohosh is one of the most familiar and commercially understood botanical actives for women's health across EU and US markets. The menopause wellness category is growing, and gummy formats offer a consumer-friendly alternative to tablets or capsules, particularly for women seeking a more pleasant daily supplement experience. Black Cohosh gummies can be positioned alongside other women's health ingredients such as Vitex, Sage, or Soy Isoflavones to create comprehensive hormonal balance formulations.

From a formulation perspective, Black Cohosh extract is heat-stable and soluble in gummy processing, which simplifies manufacturing. The primary challenge is taste — the bitter, earthy profile requires robust flavour masking. DAT Supply recommends fruit-forward profiles and may adjust sweetness levels to achieve acceptable organoleptic properties. The standardised extract form ensures consistent dosing per gummy, and the mid-tier cost allows for commercially viable retail pricing.

For pack copy in EU markets, brands must remember that Black Cohosh is a botanical on the EFSA on-hold list with no authorised health claims under Reg. (EU) 432/2012. Claim wording should avoid disease or treatment language. Brands may use non-health claim positioning such as "traditionally used in herbal wellness" or co-formulate with nutrients carrying authorised claims (e.g., Vitamin B6 for hormonal activity regulation). DAT reviews claim strategy per project with regulatory counsel and confirms certification status per project and batch before final label claims.

Supported formats

Formats this ingredient is reviewed for

DAT Supply covers gummy, capsule, softgel, tablet, powder, oral strip, liquid drop, shot, jelly and pet formats. The list below reflects every format this ingredient is reviewed for — chips link through to the manufacturing hub for each format. Final compatibility, dose and matrix are confirmed per project.

Formulation notes

Verified formulation reference across the formats this ingredient is reviewed for — the Supported formats section lists every product format this active is approved for, and the per-format Considerations section below covers matrix-specific guidance. Final formulation, dose and on-pack copy are confirmed per project.

Gummy fit
Good
Heat stable
Yes
Soluble in matrix
Yes
Cost tier
Medium

Forms available

  • Dried root extract (standardised to triterpene glycosides), powdered root

Dosage reference

Brand positioning typically ranges from 40 mg to 160 mg per serving. No reference-intake target reviewed per market established for botanicals. DAT confirms final dosage per project based on target market and claim strategy.

Taste & sensory

Bitter, earthy. Masking required in gummy formats — fruit-forward profiles (berry, pomegranate) recommended.

Manufacturing notes

Gummy-optimised dosing and format considerations. Standardised extract preferred for consistent triterpene glycoside content. Bitter taste requires robust flavour masking.

Format considerations

Per-format formulation notes

Safe-baseline considerations for each format this ingredient is reviewed for. Final formulation, dose and on-pack copy are confirmed per project.

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.
  • Matrix choice (pectin vs gelatin) and its effect on ingredient stability — confirmed per project.
  • Per-gummy dose and serving count needed to hit the label claim — confirmed per project.

Develop in gummies →

Sachets

  • Powder flow and dose accuracy at single-serve sachet weights — confirmed per project.
  • Barrier requirements (oxygen, moisture) for the active — confirmed per project.
  • Reconstitution behaviour when the sachet is dosed into water — confirmed per project.

US structure-function statements

  • Traditionally used to support women's health during menopause.Structure-function (DSHEA)
  • May help maintain comfort during hormonal transition.Structure-function (DSHEA)

Structure-function statements must appear with the FDA disclaimer in the same field of vision on the label. % Daily Value (DV) based on FDA 21 CFR 101.9.

Wording to avoid on pack copy

  • No disease claims — cannot state or imply treatment, cure, or prevention of any disease.
  • Structure-function claims must be accompanied by the FDA disclaimer: 'These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.'
  • No certification promises on pack until confirmed per project and batch documentation.
  • No guaranteed shelf-life on pack until confirmed with stability data.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Structure-function claims are permitted under DSHEA (21 USC §343(r)(6)). No Daily Value (DV) has been established for Black Cohosh under FDA 21 CFR 101.9.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Studies & evidence

External peer-reviewed sources and regulatory opinions. Citations only — DAT does not endorse the publishers.

  1. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)·EFSA Journal·2010

  2. Leach MJ, Moore V·Cochrane Database of Systematic Reviews·2012

  3. Dugoua JJ, Seely D, Perri D, Koren G, Mills E·Canadian Journal of Clinical Pharmacology·2006

  4. Nuntanakorn P, Jiang B, Yang H, et al.·Journal of Natural Products·2006

  5. Teschke R, Bahre R, Genthner A, et al.·Regulatory Toxicology and Pharmacology·2009

Catalogue match

Product concepts featuring Black Cohosh

Private-label product concepts where Black Cohosh appears in the formula. Each opens to a product brief and quote route.

Synergies & conflicts

Pairs well with

Pairs with Vitex (hormonal balance), Sage (hot flashes), Soy Isoflavones (phytoestrogen).

Care when combining with

Hepatotoxicity rare but possible — monitor liver function. Contraindicated with hormone-sensitive cancers.

Similar ingredients

Ingredients that frequently sit alongside this one in private-label supplement briefs.

Adjacent reading

Pairings, resource guides and blog notes most often associated with Black Cohosh on DAT Supply briefs.

Common pairings

Ingredients that frequently co-formulate with Black Cohosh.

Project handoff

Develop a formula featuring Black Cohosh

A ready white-label formula exists — open a product brief, or talk to our team to align the launch plan.

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Drop your work email and a member of the DAT team will follow up with the right context for this concept. Project documents, certificates and pricing are released through the project workspace in the DAT portal.

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