Background
Summary of Council decision:
Two issues were investigated, both were Upheld.
Ad description
A six-page direct mailing for an erectile dysfunction treatment included a letter from "Dr. John Hammil PhD, Product Director" on the first three pages. The letter began "Take sex to limits you never even dreamed of and leave your lover BEGGING for MORE! With Blue Devil: You will BE harder and last longer in bed. You will ENJOY worry-free sexual performance. You will HAVE enhanced sexual energy. You will GIVE you and your lover powerful spine-shuddering orgasms. You will EXPERIENCE incredible ejaculation with rapid recovery times. You will FEEL younger, more confident, happy and full of life. You will SATISFY your partner every time ... and all the time ... the safe, natural way".
The letter continued "GET A STEEL-HARD ERECTION THAT LASTS AND LASTS IN JUST A FEW MINUTES ... Forget about pills and potions that make you wait. Only Blue Devil uses exclusive Fast Acting Absorption Technology to rush its powerful prosexuals into your bloodstream up to 150% faster than anything else ... Only Blue Devil guarantees you instant, all night, sexual pleasure with a 100% safe, totally natural blend that is so powerful. Unlike the famous 'Blue Pill' and other alternatives you NEVER need a prescription or even a doctor's visit. And you NEVER have to worry about harmful side effects. With Blue Devil you get virtually instant erections and lasting energy the safe, natural way, made effective with Medical grade Ingredients."
The lower half of the third page included two testimonials. The fourth page explained how the product worked, and listed "7 Enormous Advantages of Blue Devil". The fifth page featured a comparison with a product referred to as "Blue Pill", and included the text "Before Blue Devil was put on the market, we conducted a 6 month clinical study involving 287 healthy males, ages ranging from 18-72 experiencing either mild to severe cases of sexual dysfunction ... Men consuming Blue Devil on a daily basis exhibited the highest results". The concluding paragraph on that page stated "Defeat: Erectile Dysfunction, Premature Ejaculation & Low Testosterone Once And For All! Maximize Pleasure, Libido, Arousal & Release ... Enjoy All Night Sex!".
Issue
The complainant challenged whether:
1. the medical and efficacy claims were misleading and could be substantiated; and
2. the mailing could discourage essential treatment for erectile dysfunction, which was a condition for which medical supervision should be sought.
Response
Wyldfire Ltd did not respond to the ASA's enquiries.
Assessment
The ASA was concerned by Wyldfire's lack of response and apparent disregard for the Code, which was a breach of CAP Code (Edition 12) rule 1.7 1.7 Any unreasonable delay in responding to the ASA's enquiries will normally be considered a breach of the Code. (Unreasonable delay). We reminded them of their responsibility to respond promptly to our enquiries and told them to do so in future.
1. Upheld
We noted that the CAP Code required medicines to have a licence from the Medicines and Healthcare products Regulatory Agency (MHRA) before they were marketed, irrespective of whether there was evidence to support their efficacy. The MHRA confirmed that the product did not have a licence and we therefore concluded that the ad breached the Code.
On that point, the ad breached CAP Code (Edition 12) 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.
(Medicines).
2. Upheld
We noted that the CAP Code stated that ads should not contain references to conditions for which medical supervision should be sought because of the risk that it might discourage readers from seeking essential treatment for those conditions. We noted that the mailing twice made reference to sexual/erectile dysfunction, which we considered to be a condition for which medical supervision should be sought. Because the ad made reference to that condition, we considered that it could discourage readers from seeking essential treatment for it and we concluded that the ad breached the Code for that reason also.
On that point, the ad breached CAP Code (Edition 12) 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.
(Medicines, medical devices, health-related products and beauty products).
Action
The ad must not appear again in its current form. We told Wyldfire to ensure that they did not market medicines that were not licensed by the MHRA and that they did not discourage essential treatment for conditions for which medical supervision should be sought in future. We referred the matter to CAP's Compliance team.
