Ad description
A website for feminine hygiene products, seen on 16 November 2011, stated "Natural Feminine Hygiene and Health products ... As sole distributors, let us introduce You to Dr Dolhay superior Feminine Hygiene products for intimate Sexual Health, happy carefree days free of itch, irritation and discomfort for all ladies ... Feminine problems? BUY FEMIFIT MULTI NOW at our Limited Promotional offer! Please phone Our Doctor for any concerns You may have regarding Our products on 075 XXXX XXXX ... Health Benefits of using Dr Dolhay products: Femifit Multi and Femifit Wash provide complete cleanliness which makes you feel more fresh, healthy and confident! No more embarrassing odor or discharge! You are in charge of vaginal discharge as our products help balance your pH right! Also enjoy Reduced Risk of Cervical Cancer and STDs!"
A testimonial stated "After my abnormal cervical smear test at the age of 19, I was recommended to use Dr Dolhay products. Since then I have never had any problems and could not be without Dr Dolhay products. As the number 1 feminine hygiene products range, this being the reason I decided to introduce the finest natural feminine hygiene products available to all women within the UK".
Issue
Two complainants challenged whether the claim "enjoy Reduced Risk of Cervical Cancer and STDs" was misleading and irresponsible.
Response
Ladydologz Natural Feminine Hygiene and Health (Ladydologz) believed the claim was accurate and could be substantiated. They said Femifit products were registered as CE marked medical devices or CE marked cosmetic products, and provided evidence of registration as a medical device. They said the products were not able to treat or prevent any kind of cancer, but they could lower the risk. They said they chose their words carefully when preparing their advertising to make this clear.
They said the ingredients within the products included prebiotics and probiotics from asses' milk, and these were proven to balance the vaginal PH. They said the products built up natural protection within the vagina, and this reduced the risk of viruses being able to enter the blood stream, thus reducing the risk of cancer. They provided a study of 120 women which they said proved using the product reduced the vaginal PH, making it more acidic, and that this indicated an increase in the amount of Doderlein-bacteria. They said that for legal reasons they were not able to provide the quantitative composition of the ingredients, but that they had proof from the manufacturer the products were successful after clinical trials. Ladydologz provided information from the manufacturer about the product range. They said there were no known side effects to using the products. They said the normal vaginal PH was acidic, and when this was the case it was less likely that harmful bacteria or viruses would be able to get into the blood stream. They said using their products meant women built up a natural self-protection, which reduced the risk of feminine problems. They said other products such as soap changed the PH to alkaline, which could lead to health problems. They provided a journal article about the probiotic properties of vaginal bacteria isolated from healthy women. They also provided a journal article about possible links between vaginal inflammation in women with the human papilloma virus (HPV) and cervical cancer, and an article about possible links between inflammation and cancer in general.
Assessment
Upheld
The ASA acknowledged Ladydologz had provided evidence their products were licensed as medical devices. We noted this meant the products were safe and fit for their intended purpose, but that we would still need to see robust evidence for claims being made for the products. We considered that for claims a product could reduce the risk of serious medical conditions such as cancer and sexually transmitted diseases (STDs) we would expect to see sound data, relevant to the claim made, collated to form a body of evidence. We would normally expect this to include at least one experimental human study (ideally double-blind and placebo-controlled) and often observational human studies, and would also take into account whether these studies were peer reviewed and/or published in reputable journals. We did not consider journal articles regarding possible links between inflammation and cervical cancer were sufficient as they did not refer to the product being advertised, or to douching in general. We noted the study submitted by the advertiser referred to Colpo-Cleaner Lactose Effervescent Tablets, which we understood were a different product to the Femifit tablets. In addition we noted the study did not refer to cancer or STDs, state if it was double-blinded or appear to have been published or peer-reviewed. Because we had not seen robust evidence that using the product could reduce the risk of developing cancer or contracting STDs, we concluded the claim was misleading.
We noted Ladydologz said they did not believe the product would treat cancer. However, we also noted the customer testimonial stated they had used the product after an abnormal smear test, and that they had not had any problems since, which we considered implied the product was suitable for use in respect of early abnormalities of the cervix.
We also considered that the claim "enjoy Reduced Risk of Cervical Cancer and STDs" might discourage people from using a barrier method of protection, which we understood was recommended by the NHS as the best way to avoid contracting STDs, including HPV which was linked to the development of cervical cancer. We therefore concluded the claim was irresponsible.
The ad breached CAP Code (Edition 12) rules
1.3
1.3
Marketing communications must be prepared with a sense of responsibility to consumers and to society.
(Social responsibility),
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation),
3.47
3.47
Claims that are likely to be interpreted as factual and appear in a testimonial must not mislead or be likely to mislead the consumer.
(Endorsements and testimonials),
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
and
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
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
).
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.
(Medicines, medical devices, health-related products and beauty products)
Action
The ad must not appear again in its current form. We told Ladydologz not to state or imply their products could treat, or reduce the risk of developing, medical conditions unless they held robust evidence this was the case.
