UK ASA Ruling: Femarelle

“A magazine ad for Femarelle was headlined “Thank you Femarelle, for giving me my life back!” and included the claim “Hot flushes, mood swings, crushing fatigue, sleepless nights … my life had changed beyond all recognition. I didn’t feel like myself at all. Nothing seemed to help. Then a friend suggested that I try Femarelle. I could really feel it working, even after just a couple of weeks. My mood lifted, I’ve been sleeping much better and those embarrassing hot flushes have nearly disappeared. I am really starting to feel like my old self again, ready to get on with my life!”. Further text stated “90% of menopausal women report an improvement in their health and wellbeing after just 1 month”, “Femarelle has no effect on the breast or uterus tissue or on blood clotting – and is recommended by leading Doctors and Gynaecologists worldwide” and “Femarelle has been the subject of 24 published clinical studies and medical abstracts, confirming its efficacy and safety for menopausal women. In December 2009 Femarelle was presented at the leading Medical Congress of the British Menopause Society. All studies are available online at [website]”. A round stamp-like image contained the text “ENDORSED & RECOMMENDED … by Leading Doctors and Gynaecologists” and text at the bottom of the ad stated “Proven and effective – without the risks”.”

ASA Adjudication on Passion for Life Healthcare (UK) Ltd 
Passion for Life Healthcare (UK) Ltd

http://asa.org.uk/ASA-action/Adjudications/2011/2/Passion-for-Life-Healthcare-(UK)-Ltd/TF_ADJ_49791.aspx

Ad
A magazine ad for Femarelle was headlined “Thank you Femarelle, for giving me my life back!” and included the claim “Hot flushes, mood swings, crushing fatigue, sleepless nights … my life had changed beyond all recognition. I didn’t feel like myself at all. Nothing seemed to help. Then a friend suggested that I try Femarelle. I could really feel it working, even after just a couple of weeks. My mood lifted, I’ve been sleeping much better and those embarrassing hot flushes have nearly disappeared. I am really starting to feel like my old self again, ready to get on with my life!”. Further text stated “90% of menopausal women report an improvement in their health and wellbeing after just 1 month”, “Femarelle has no effect on the breast or uterus tissue or on blood clotting – and is recommended by leading Doctors and Gynaecologists worldwide” and “Femarelle has been the subject of 24 published clinical studies and medical abstracts, confirming its efficacy and safety for menopausal women. In December 2009 Femarelle was presented at the leading Medical Congress of the British Menopause Society. All studies are available online at [website]”. A round stamp-like image contained the text “ENDORSED & RECOMMENDED … by Leading Doctors and Gynaecologists” and text at the bottom of the ad stated “Proven and effective – without the risks”.
Issue

The Proprietary Association of Great Britain (PAGB) challenged whether:

1. the ad made medicinal claims, such as the alleviation of “hot flushes, mood swings, crushing fatigue, sleepless nights” and “90% of menopausal women report an improvement in their health and wellbeing”;

2. the claim “ENDORSED & RECOMMENDED By Leading Doctors & Gynaecologists” misleadingly implied a medical benefit;

3. the ad misleadingly implied Femarelle was “clinically proven” as a medicine to help with the menopause;

4. the claims “Proven and effective – without the risks” and “Femarelle has no effect on the breast or uterus tissue or blood clotting” implied Femarelle was an alternative to Hormone Replacement Therapy (HRT).

Response

1. Passion For Life Healthcare (UK) Ltd (Passion for Life) said the ad did not state that the product alleviated “hot flushes, mood swings, crushing fatigue, sleepless nights” and that these were common symptoms of the menopause whose inclusion in the ad was merely intended to indicate that the product may be relevant to other women suffering from similar symptoms. They said that the claim “90% of menopausal women report an improvement in health and wellbeing” was not a medicinal claim and believed the menopause itself was not a medical condition.

2. They believed that general endorsements such as “ENDORSED & RECOMMENDED by Leading Doctors & Gynaecologists” were permitted and believed that the ad complied with regulatory and statutory requirements.

3. They did not believe the ad implied Femarelle was ‘clinically proven’ as a medicine to help with symptoms of the menopause and stated that the ad made clear that the product could potentially help women who were in the menopause stage of life. They said readers were provided with details of how to obtain the clinical trials on the product and, in the context of the ad as a whole, “Clinically proven” was true.

4. They stated that the ad made no reference to hormone replacement therapy and that the references to the product having “no effect on the breast or uterus tissue or blood clotting” was to indicate that women of menopausal age were more prone to those conditions and that it was therefore a further indication that Femarelle was a suitable product for that group of women.

Assessment

1. Upheld

The ASA noted the ad for the food supplement appeared in Menopause Matters magazine and considered that readers would understand that the magazine and its contents, including the ads, were targeted at women who were experiencing symptoms associated with the menopause. We considered that most readers would interpret the text “Hot flushes, mood swings, crushing fatigue, sleepless nights” as a claim that woman featured in the ad was suffering from symptoms associated with the menopause. We considered that most readers would interpret the additional text “Then a friend suggested that I try Femarelle. I could really feel it working, even after just a couple of weeks. My mood lifted, I’ve been sleeping much better and those embarrassing hot flushes have nearly disappeared” and the statement “90% of menopausal women report an improvement in their health and wellbeing” as a claim that the product treated those symptoms. We considered that the ad included claims that implied the product would have a physiological effect of relieving symptoms associated with menopause. We therefore concluded that the ad presented Femarelle as a medicinal product and made health claims without the relevant authorisations.

On this point the ad breached CAP Code (Edition 12) rule 12.1 (Medicines, medical devices, health-related products and beauty products).

2. Upheld

We considered the claim “ENDORSED & RECOMMENDED By Leading Doctors and Gynaecologists” implied the product would have a physiological effect of relieving symptoms associated with menopause. We therefore concluded that the ad presented Femarelle as a medicinal product and made health claims without the relevant authorisations.

On this point the ad breached CAP Code (Edition 12) rule 12.1 (Medicines, medical devices, health-related products and beauty products)

3. Upheld

We considered that most readers would interpret the claim “Clinically Proven” within the context of the implied claims that Femarelle could be taken to relieve physical symptoms of the menopause. We therefore concluded that the ad presented Femarelle as a medicinal product and made health claims without the relevant authorisations.

On this point the ad breached CAP Code (Edition 12) rule 12.1 (Medicines, medical devices, health-related products and beauty products).

4. Upheld

We considered that, within the context of the ad as a whole, most readers would interpret the text “Proven and effective – without the risks” as a claim that Femarelle was an effective treatment for some of the physical symptoms of the menopause, but without the risks that may be associated with other types of treatment for the condition. We considered that most readers of Menopause Matters would be aware of the potential risks associated with HRT and would interpret the claim “Femarelle has no effect on the breast or uterus tissue or on blood clotting” as a statement that the product effectively treated the symptoms of the menopause without the increased risks of some cancers and blood clotting that sometimes associated with the long-term use of HRT.

On this point the ad breached CAP Code (Edition 12) rules 12.19 (Medicines, medical devices, health-related products and beauty products).

Action

The ad should not appear again in its current form.

Adjudication of the ASA Council (Non-broadcast)

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