Background
Summary of Council decision:
Two issues were investigated, of which both were Upheld.
Ad description
A poster for a product that claimed to relieve the symptoms of the menopause stated "Horrible Hot Flushes Gone! Massive Mood Swings Gone! Nasty Night Sweats Gone! Menopause Miseries™? Discover Relief Beyond Belief!™ Guaranteed to stop Hot Flushes, Night Sweats, Mood Swings, Lack of Energy, Sleeplessness, etc. Clinically Proven* and Doctor Recommended. Amberen is unique. It prompts your body to make its own natural Estrogen during your menopause, restoring proper hormonal balance from within. 95% of women find relief starts within 1-4 weeks ... Amberen is a major breakthrough in safe, drug-free Menopause Relief … Forget dangerous HRT, with all its health risks and nasty side-effects …". Small print stated "*Very few other natural products are ever Clinical Tested (sic). If they were, almost all would be shown to be ineffective … Amberen is an all-natural extract, mainly of succinates, from Baltic Amber."
Issue
1. The complainant challenged whether the efficacy claims made for the product could be substantiated.
2. They also challenged whether the claim "Forget dangerous HRT, with all its health risks and nasty side-effects" exaggerated the potential negative consequences of hormone replacement therapy (HRT).
Response
1. & 2. USA Direct Ltd (USA Direct) said there were several health risks associated with taking HRT and these were well documented in clinical studies carried out throughout the world. The dangers included, but were not limited to, increased risks of breast cancer, blood clotting, thrombosis, and other forms of cardiovascular disease and a Google search for "What are the dangers of taking HRT" supported this. They also said Amberen was probably the most effective alternative to HRT, as it had no health risks or side effects and provided relief to the suffering associated with menopause symptoms at all levels. It was also only one of a very small number of non-pharmaceutical products to have been subjected to voluntary clinical testing to prove its efficacy.
Assessment
1. & 2. Upheld
The ASA considered that the claims that the product could relieve symptoms of the menopause were medicinal claims. The complainant challenged whether the efficacy claims could be substantiated and whether the claim "Forget dangerous HRT, with all its health risks and nasty side-effects" exaggerated the potential negative consequences of HRT.
However, because the claims that the product could be used with a view to treating or preventing a range of adverse conditions, and were classed by the Medicines and Healthcare products Regulatory Agency (MHRA) as medicinal claims, we understood that USA Direct Ltd were required to hold a marketing authorisation for the product from the MHRA before marketing it to UK consumers. Because USA Direct Ltd did not hold the relevant authorisation, we did not investigate the ad further, but reminded USA Direct Ltd of their obligation to check their claims were legal under medicines law (CAP Code rule
12.11
12.11
Medicines must have a licence from the MHRA, VMD or under the auspices of the EMA before they are marketed. Marketing communications for medicines must conform with the licence and the product's summary of product characteristics. For the avoidance of doubt, by conforming with the product's indicated use, a marketing communication would not breach rule
12.2
12.2
Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see rule 12.11).
Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
Marketing communications must not suggest that a product is "special" or "different" because it has been granted a licence by the MHRA, VMD or under the auspices of the EMA.
. We concluded that the ad breached the Code.
The ad breached CAP Code (Edition 12) rules
12.2
12.2
Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see rule 12.11).
Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
and
12.6
12.6
Marketers should not falsely claim that a product is able to cure illness, dysfunction or malformations.
(Medicines, medical devices, health-related products and beauty products) and
12.11
12.11
Medicines must have a licence from the MHRA, VMD or under the auspices of the EMA before they are marketed. Marketing communications for medicines must conform with the licence and the product's summary of product characteristics. For the avoidance of doubt, by conforming with the product's indicated use, a marketing communication would not breach rule
12.2
12.2
Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see rule 12.11).
Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
Marketing communications must not suggest that a product is "special" or "different" because it has been granted a licence by the MHRA, VMD or under the auspices of the EMA.
(Medicines).
Action
The ad must not appear again in its current form. We told USA Direct Ltd to ensure that their marketing complied with the relevant statutory requirements in future.
