Note: This advice is given by the CAP Executive about non-broadcast advertising. It does not constitute legal advice. It does not bind CAP, CAP advisory panels or the Advertising Standards Authority.
Rule 12.1 of the British Code of Advertising, Sales Promotion and Direct Marketing (the CAP Code) requires marketers of health and beauty products to ensure that clinical trials are held in support of any health and beauty claims made in ads.
In Autumn 2004, CAP considered the use of electrical muscle stimulation devices as an aid to reducing urinary incontinence. Urinary incontinence can affect women throughout all stages of their lives but particularly after pregnancy and childbirth and during the menopause. Urinary incontinence is defined as “the involuntary loss of urine that is a social or hygienic problem”. Loss of control of the pelvic floor muscles, for example after childbirth, can lead to this involuntary loss of urine. Incontinence of faeces can result from loss of control of the anal sphincter but is not discussed here.
Urinary incontinence is frequently embarrassing and has led to medical intervention from many sources. The Department of Health has recommended that conservative methods, for example a regimen of pelvic floor exercises, should always be tried first. If those measures are unsuccessful, surgical procedures could be desirable.
If a woman is unable to contract her pelvic floor muscles, if the muscles are very weak or she has poor muscle awareness, a battery-operated electrical muscle stimulation device may be used to help identify those muscles. Such devices (variously referred to as neuromuscular electrical stimulation, neuromuscular stimulation, electrical stimulation, muscular electrical stimulation, functional electrical stimulation, and trophic stimulation depending on the specification of the device) use a vaginal probe, are operated by a hand-held control unit and are intended to train the pelvic floor muscles by producing a series of electrically induced contractions, to improve strength and function.
CAP understands that the Medicines and Healthcare products Regulatory Agency (MHRA) are likely to classify hand-held units of this nature as medical devices and as such marketers will need a licence. For the definition of a medical device and for more information about the classification procedure, marketers are advised to seek the assistance of the Devices division of the MHRA (email devices@mhra.gsi.gov.uk). The MHRA can also advise about what contraindications should be stated in accompanying usage instructions distributed with the product.
CAP has recently accepted that electrical stimulation devices may be targeted at sufferers of mild incontinence so long as a Devices Licence is held and claims do not go beyond the terms of that licence. Claims for the devices may include information that the product is an accompaniment to pelvic floor muscle rehabilitation but should not include claims such as ‘cure’ (NuroMed Ltd, 16 February 2005). The ad should not discourage essential treatment and should, if possible, state the device should not be used in isolation, i.e. users should “join in” by contracting their pelvic floor muscles at the same time as the stimulation is felt to help re-educate the muscles in question. The ad may also include information about how the device is used, for example, “An internal probe is inserted into the vagina and operated using a hand-held control unit”. Evidence suggests that optimum usage levels are 15 to 30 minutes daily and usage instructions of that nature may be included in marketing communications.
Because incontinence could be caused by, or a symptom of, more serious medical conditions, marketers could helpfully refer users to their GP (Rule 12.2).
Marketers wanting to make claims about the efficacy of their product based on clinical data or customer surveys should provide that information to the CAP Copy Advice team for consideration. Customer satisfaction surveys should not be presented as clinical trials but could form the bases of claims such as “Hundreds of satisfied customers” or “Many satisfied customers have provided testimonials, available to read on request”. Marketers should be aware that rules 3.45, 3.48 of the CAP Code explains that testimonials can be used only if they are demonstrably genuine and, unless the testimonials are in the public domain, marketers should hold permission to use them. That might affect whether the testimonials can be used at all: those submitting them might not want to have their name included in a marketing communication for such an intimate product.
Last modified : 29 March 2012