The claims, backed by several clinical studies, referenced the supplement’s ability to reduce, "hot flushes, mood swings, crushing fatigue, sleepless nights" in menopausal women and said the product was "endorsed and recommended by leading doctors and gynaecologists".
The product claimed to have no effect on “breast or uterus tissue or blood clotting”, effects that have been linked with hormone replacement therapies commonly used by menopausal women.
But the ASA backed the Proprietary Association of Great Britain (PAGB) challenge to the claims and found them to be unauthorised medicinal claims.
Femarelle product manager Alison Free told NutraIngredients this morning that the company disagreed and was disappointed with the ruling but had abided by it because, “there is not much point fighting it in the current climate where product claims are so restricted.”
But she added: “The claims were not medicinal because menopause is not a disease but a lifestage.”
She said the company had received advice from the UK Food Standards Agency, claim consultants and the UK Health Food Manufacturers’ Association (HFMA) in formulating the claims, and would now pursue a registration for the product under the EU Traditional Herbal Medicinal Products Directive (THMPD).
The product website continues to carry links to scientific literature in the area and soft claims about menopause and bone health. It rather frankly states:
“There is a lot of inconsistency shown in trials of plant derived supplements. This is mainly due to 2 problems:
- Difficulty with standardizing the ingredients. Whether soy, black cohosh or red clover, each plant has thousands of species, a different chemical profile and can vary from season to season.
- As they are not standardized, it is difficult to show consistency in clinical trials.
This is why most of these products have no viable, scientific and clinical backup proving their efficacy, let alone their safety.”
She said a UK FSA representative had told the company it was a difficult and ambiguous time for claim-making with, “everything up in the air with regard to the EU nutrition and health claims regulation and the rulings from the European Food Safety Authority (EFSA).”
She said the marketing change had not affected sales of the product.