Health Claims References

For the woman who reads the bottle and looks up the trial.

This page exists because the £27.99 supplement she has done the research on deserves the same transparency as the £380 prescription she's been waiting twelve weeks to discuss with her GP.

Every claim Belle Balance makes about its ingredients sits in one of three places below. Authorised health claims that have passed regulatory scientific assessment. Research-context references for ingredients with substantial published literature but no authorised claim. Traditional-use references for adaptogens with documented historical use but no modern clinical claim.

None of this is a substitute for medical advice. Belle Balance is a food supplement, not a medicine — and we don't claim it treats, cures, or prevents any condition. What it gives you is a transparent ingredient stack at the doses the research actually supports, and the full audit trail behind every word on the product page.

How to read this page

The framework Belle Balance operates under has three claim tiers, in descending order of regulatory weight.

Tier 1 — Authorised health claims. Statements that have passed scientific assessment by EFSA (the European Food Safety Authority) and are listed on the GB Nutrition and Health Claims Register administered by the FSA. Worded verbatim from the register. The seven authorised claims Belle Balance cites all sit at this tier.

Tier 2 — Research-context references. Citations of published research on an ingredient, framed as context (the dose the research used, the populations studied) rather than as substantiation of a specific health claim. Belle Balance uses this framing for inositol — an ingredient with substantial published literature but no authorised health claim on the GB register.

Tier 3 — Traditional-use references. Citations of an ingredient's documented historical use in established herbal traditions. Belle Balance uses this framing for Rhodiola Rosea (Russian and Scandinavian adaptogenic tradition) and Shatavari (Ayurvedic herbal practice). The phrase "based on traditional use" appears wherever these ingredients are referenced on the product page.

Tier 1 · Authorised health claims

Each claim below is reproduced verbatim from the GB Nutrition and Health Claims Register. To make an authorised claim on a product, the product must deliver at least 15% of the Nutrient Reference Value (NRV) per recommended daily intake. Every Belle Balance claim sits well above this threshold — the lowest is Magnesium at 40% NRV per sachet.

The Reference column above shows the EFSA opinion ID under which each claim was originally assessed and authorised. These IDs are the canonical identifiers used across the register and in regulatory correspondence.

Tier 2 · Research-context for inositol

Inositol is the headline ingredient in Belle Balance — 4,000mg of Myo and D-Chiro Inositol in a 40:1 ratio per daily sachet. There is no authorised health claim for inositol on the GB Nutrition and Health Claims Register. Belle Balance does not claim a specific health benefit from inositol.

What it does cite is the published research context that shaped the dose and ratio.

The 4,000mg daily dose is the dose used in much of the published myo-inositol research, including the systematic review:

This review aggregated controlled trials of myo-inositol at the 4,000mg daily dose. Subsequent and ongoing trials registered through ClinicalTrials.gov continue to use this dose — a search of the registry under "myo-inositol" returns trials at this dose conducted across multiple research populations and indications, with the 40:1 Myo to D-Chiro ratio being the most commonly studied combination.

This is research context, not claim substantiation. The ingredient is included at the dose the literature consistently uses. What that ingredient does for you is your own body's answer — which is why the 30-day money-back guarantee exists.

Tier 3 · Traditional-use references

Rhodiola Rosea (300mg, standardised to 3% Rosavins / 1% Salidroside)

Rhodiola Rosea is a flowering plant native to mountain regions of Europe, Asia, and North America. Its rhizome and root have been used in traditional herbal medicine in Russia, Scandinavia, and Central Asia for several centuries, classified within the broader category of adaptogens — herbs traditionally used to support the body's response to physical and mental stress.

Belle Balance includes Rhodiola Rosea at 300mg, standardised to 3% Rosavins and 1% Salidroside — the standardisation typical of contemporary herbal extracts. The claim language used on the product page is "traditionally used in herbal practice as an adaptogen, based on traditional use" — framed under the UK's recognition of traditional herbal use within the broader herbal medicines framework (THMPD — Traditional Herbal Medicinal Products Directive 2004/24/EC, retained in UK law).

Belle Balance does not make any specific health benefit claim for Rhodiola Rosea. The ingredient is included for the traditional adaptogenic role it has played across documented herbal traditions.

Shatavari (200mg)

Asparagus racemosus — commonly known as Shatavari — is a climbing plant native to the Indian subcontinent. Its roots have been used in traditional Ayurvedic herbal practice for several thousand years, classified within the Rasayana category of herbs traditionally used for women's wellbeing across the female lifecycle. The Sanskrit name translates as "she who possesses a hundred husbands" — a poetic reference to its traditional use within Ayurvedic medicine for women's health.

Belle Balance includes Shatavari at 200mg. The claim language used on the product page is "traditionally used in Ayurvedic herbal practice for women's wellbeing, based on traditional use" — framed under the UK's recognition of traditional herbal use.

No other UK hormonal balance supplement currently includes Shatavari. Belle Balance does not make any specific health benefit claim for Shatavari. The ingredient is included for its long-documented traditional role.

Femme Flora references

Femme Flora is a pre & probiotic complex containing 16 strains of live cultures (10 Lactobacillus, 6 Bifidobacterium) at 50 Billion CFU per serving, with a 250mg prebiotic fibre blend and 50mg organic cranberry extract.

Live cultures and cranberry have no authorised health claims on the GB Nutrition and Health Claims Register. This means the framework Femme Flora operates under is different from Belle Balance. There are no Tier 1 authorised claims to cite. The product page works in Tier 2 framing throughout — published research referenced as context for ingredient choices and dose decisions, not as substantiation of specific health claims.

Each citation referenced on the Femme Flora product page is reproduced below, with the published source it derives from.

Tier 2 · Research-context for live cultures

1 · Oral probiotic delivery to the vaginal tract

The Femme Flora product page describes the route by which oral Lactobacillus reaches the vaginal tract via the gut-rectum pathway. The original randomised trial cited:

This was a randomised, placebo-controlled trial in 64 healthy women. Daily oral probiotic supplementation significantly altered vaginal flora compared to placebo over the trial period. The trial established the oral-administration mechanism that subsequent literature has continued to investigate.

2 · The IgA axis and gut-vagina mechanism

The Femme Flora product page describes Lactobacillus-reactive immune cells travelling via the IgA axis, supporting vaginal defence from the gut. The 2025 paper cited:

This is a review paper proposing the immunological mechanism by which oral probiotic Lactobacillus may promote vaginal colonisation via IgA-mediated regulation. It is described on the product page as a 2025 review — this is research context, not confirmed evidence of a specific product effect.

3 · Vaginal detection of orally-administered Lactobacillus

The Femme Flora product page references oral L. gasseri detection in vaginal samples in over 55% of women across an 18-day intervention. The original randomised trial cited:

This was a randomised, double-blind, placebo-controlled trial in 48 healthy premenopausal women aged 18–45. Vaginal samples were collected every three days across an 18-day intervention. L. gasseri was detected in vaginal swabs of 55.9% of women in the active probiotic groups, statistically significant compared to placebo (P = 0.005). The trial was registered on ClinicalTrials.gov under NCT05688397.

Tier 2 · Research-context for cranberry

4 · Cranberry products and urinary tract infection risk

The Femme Flora product page references the 2023 Cochrane Review on cranberry products and urinary tract infections:

This Cochrane systematic review aggregated 50 randomised controlled trials with 8,857 randomised participants. The headline meta-analysed finding was a relative risk of 0.70 (95% CI 0.58 to 0.84) — equivalent to an approximately 30% reduction in UTI risk — for cranberry products versus placebo or no treatment, in women with recurrent UTIs.

Femme Flora cites this review as published research relevant to cranberry as an ingredient — not as substantiation of a specific Femme Flora product effect. The review explicitly notes that the evidence does not support cranberry use in pregnant women, in the elderly, or in patients with bladder emptying problems. Femme Flora is a food supplement, not a medicine, and is not intended to treat or prevent urinary tract infections.

Tier 1 · Authorised health claims (Femme Flora)

None. Live cultures and cranberry do not have authorised health claims on the GB Nutrition and Health Claims Register. Femme Flora makes no Tier 1 claims, and the product page does not attribute any specific health benefit to the supplement itself.

Tier 3 · Traditional-use references (Femme Flora)

None applicable. Femme Flora does not include any ingredients framed under traditional herbal use.

Regulatory framework

Belle Balance and Femme Flora operate under the prevailing UK regulatory framework for food supplements. The relevant bodies and frameworks:

• FSA — Food Standards Agency, administers the GB Nutrition and Health Claims Register.
• EFSA — European Food Safety Authority, original scientific assessor of the authorised claims listed on the GB register.
• Commission Regulation (EU) No 432/2012 — the original list of permitted health claims, retained in GB law.
• ASA / CAP Code — Advertising Standards Authority and the UK Code of Non-broadcast Advertising and Direct & Promotional Marketing, governing what supplement brands can and cannot say in advertising.
• THMPD — Traditional Herbal Medicinal Products Directive 2004/24/EC, retained in UK law — the framework underpinning "based on traditional use" language for herbal ingredients.
• MHRA — Medicines and Healthcare products Regulatory Agency, the regulator that maintains the boundary between food supplements and medicines.