The website www.ladycare-uk.com, seen on 4 January 2019, promoted LadyCare “a novel discreet device, found to reduce menopause symptoms in 71% of cases”. Text on the home page stated, “LADYCARE MENOPAUSE … PROVEN TO REDUCE OR COMPLETELY ELIMINATE MENOPAUSE SYMPTOMS, IN OVER 71% OF WOMEN … May reduce Hot Flushes, Increased Energy, Weight Reduction, Better Skin Tone, Improved Mood and more … You may find relief for up to 24 different symptoms of menopause such as night sweats, weight gain and mood swings … Menopause symptoms are the result of diminishing natural hormones which then causes an imbalance of the ANS (autonomic nervous system). LadyCare has been shown to rebalance the ANS in many cases”.
A page entitled “LadyCare Research” outlined the details of “two major studies” which “reveal[ed] that LadyCare could help relieve menopausal symptoms”. The page listed a number of “menopause symptoms”.
The complainant challenged whether the efficacy claims for the LadyCare were misleading and could be substantiated.
LadyCare Menopause Ltd said their website described the outcome of clinical trials and reported observations from their customers, but did not make efficacy claims. They believed they were entitled to report findings from trials that had investigated the effectiveness of the device and to explain what they and their customers believed it could do.
They said LadyCare was registered as a Class I medical device by the Medicines and Healthcare products Regulatory Agency (MHRA) and that the claims in their ad complied with an agreement they had reached with the Office of Fair Trading (OFT) in 2006.
The ASA understood that on 24 November 2006, Magnopulse Ltd, a company which at that time manufactured and sold magnetic therapy products, and its directors Derek Price and Wendy Price in their personal capacity, gave undertakings to the court following notification by the OFT that it believed the company's old advertising claims were misleading under the Control of Misleading Advertisements Regulations (CMARs). Those undertakings stated that they would not make advertising claims stating or giving the impression that (among other things): magnetic products will produce a therapeutic effect for those who wear or use them (as opposed to saying that they may have such an effect and/or some trials have shown that there may be such an effect and/or some consumers have reported such an effect); the cause of the products' therapeutic effect is (as opposed to may be) a specified physiological mechanism; and the products' therapeutic efficacy is established or proved by clinical and/or scientific trials (as opposed to the possibility of the therapeutic effect having been suggested or reported in some trials under medical or scientific supervision).
At the time the claims appeared on the ladycare-uk.com website, Derek Price and Wendy Price were the directors of LadyCare Menopause Ltd (previously LadyCare Lifetime Ltd). As of 26 May 2008 the Consumer Protection from Unfair Trading Regulations 2008 (the CPRs) revoked and replaced the CMARs. The OFT ceased to exist on 1 April 2014. The CAP Code stated that the ASA may take the CPRs into account when it rules on complaints about marketing communications that are alleged to be misleading and that the ASA will take into account the impression created by marketing communications as well as specific claims, ruling on the basis of the likely effect on consumers. It also stated that advertisers must hold adequate evidence for their claims.
We noted that the top of the home page included the product name “Ladycare Menopause” and that two of the further information tabs were labelled “How it Helps” and “Can it Help Me”. The most prominent claim on the page stated “PROVEN TO REDUCE OR COMPLETELY ELIMINATE MENOPAUSE SYMPTOMS, IN OVER 71% OF WOMEN”. The third of four bulleted claims below that text stated “Natural Alternative for Menopause”. Further down the page text stated “LadyCare a novel discreet device, found to reduce menopause symptoms in 71% of cases, using unique patented SM fields in a safe, gentle but powerful way”. Further claims on the page included “LadyCare is a small, yet extremely powerful, therapeutic device … May reduce Hot Flushes, Increased Energy, Weight Reduction, Better Skin Tone, Improved Mood and more … A million women worldwide use LadyCare to Reduce Hot Flushes … It’s not just hot sweats that LadyCare helps reduce. You may find relief for up to 24 different symptoms of menopause such as night sweats, weight gain, and mood swings … Menopause symptoms are the result of diminishing natural hormones which then causes an imbalance of the ANS (automatic nervous system). LadyCare has been shown to rebalance the ANS in many cases”. The page then listed various symptoms of the menopause and included the names and qualifications of two doctors who were said to have conducted research on the device together with brief descriptions of their research, which included a quote from Dr Michael Kucera that read “We have trialled LadyCare on around 20 patients … With the exception of one patient they all improved 100% with resolution of symptoms”.
We considered that consumers were likely to understand from the home page that the LadyCare device had a therapeutic effect for those who experienced some or all of the symptoms of the menopause; that the product’s therapeutic effect was the result of a specified physiological mechanism (namely, rebalancing the ANS); and that the product’s efficacy was proved by clinical and/or scientific trials. While we accepted that some of the language used was conditional, such as “LadyCare has been shown to rebalance the ANS in many cases” and “may reduce [symptoms]”, in the context of the page as a whole we considered those statements would be understood only as a recognition that ‒ as with many medical interventions that were proven to be efficacious ‒ the LadyCare device would not necessarily have the same effect for every woman who used it. It did not alter the overall impression that the product was proven to be efficacious in the treatment of symptoms of the menopause.
We had never previously accepted that the claimed therapeutic effects of magnets or magnetic devices were supported by satisfactory scientific evidence. We therefore considered it necessary to see sound data, relevant to the claims made, collated to form a body of evidence that ideally included at least one adequately controlled experimental human study. LadyCare had supplied no evidence to support the claims and the research featured on their website consisted entirely of self-assessment surveys. Such evidence was not acceptable as sole support for the claims made. For that reason, we concluded that the website breached the Code.The ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).
The claims must not appear again in their current form. We told LadyCare Menopause Ltd not to make efficacy claims about their device, for example, in relation to relieving symptoms of the menopause, in the absence of adequate evidence. We also told them not to state or imply that the product had an established physiological effect on the body, for example, rebalancing the ANS.