ASA Adjudication on Prime Health Direct Ltd

Ad

Three leaflets from Prime Health Direct included claims for a number of products: Gerovital GH3 Gold, Gerovital GH3 Advance, sHGH Sublingual, Kreflex, Kreflex Cream and Kreflex Advance, Rosehip, Saw Palmetto and Horny Goat Weed Extract.

Issue

The Health Food Manufacturers Association (HFMA) challenged whether the following claims were misleading and could be substantiated and whether they implied the products could be used to prevent or treat illness, elevate mood or enhance normal performance:

1.  "Gerovital GH3 Gold  Whatever your age, help yourself NOW to: Less body fat and leaner muscle  Increased memory, concentration and brainpower  Smoother, healthier, blemish-free skin  Enhanced sexual energy  More flexible, pain free joints  Fuller, lustier grey-free hair  Better, more refreshing sleep  Greater strength and vigour  Improved resistance to infections ... Enhanced sex drive, normalised cholesterol levels, healed peptic ulcers, less painful arthritis ... Effect is cumulative - taken over 3 months ... has been credited with improving sleep, mobility and memory, and with restoring hair colour".

2.  "Gerovital GH3 Advance is a super-charged variation with an enhanced procaine molecule to kick-start your metabolism and produce faster improvements".

3.  "Unique triple potency sHGH, formulated to:  Increase energy  Reduce fat  Gain strength  Increase stamina  Improve memory  Re-hydrate skin  Heighten mood  Improve sexual desire".

4.  "Only Kreflex can claim to do ALL the following:  Enhance cell membranes to stop inflammation  Restore flexibility and Stimulate Renewal of Cartilage  Achieve pain free levels within 5-20 days  Achieve benefits for diverse forms of arthritis  Have no known side effects  Be anti-inflammatory and immunotherapeutic  Speed up the healing of sprains and strengthen joints, preventing future injury  Increase range of motion  Help repair ageing and damaged joints in the knees, hips, spine and hands ... Works Fast ... Enhanced Absorption And Efficacy For Your Joints ... Improved Joint Mobility ... Supports Cartilage Building and Repair ... Effective Back Pain Relief ... The 250mg of Glucosamine in Kreflex Advance provides the restorative power to your joints of 2,500mg of Glucosamine taken on its own! ... Kreflex capsules and Kreflex Cream can fight the infection, remove inflammation and restore mobility.  Kreflex Advance will restore your joints to their healthy condition before inflammation and protect against future joint pain ... KREFLEX  KREFLEX CREAM  KREFLEX ADVANCE ... Anti inflammator  Immune modular  Shown to achieve significant benefits within 1 day  Enhances cell membranes to stop inflammation  Restores flexibility  Achieves pain free levels within 5-30 days  Shown to achieve benefits for diverse forms of arthritis  Benefits shown to continue after cessation  No known side effects  Very safe at high dosage levels".

5.  "Rosehip ... Who would have thought this natural plant extract could hold the secret to arthritis relief? ... also offers great relief from the pain caused by arthritis and osteoarthritis - without the side effects of anti-inflammatory drugs".

6.  "Prostabeta Advance ... the all-natural multi-generation supplement to help any man who has prostate enlargement ... we have created a sensational new improved natural choice that combines unprecedented effectiveness with no unpleasant side-effects ... If doctors decide your prostate has become cancerous, your life will be at risk ... Even if the surgery is successful, a huge percentage of men find themselves both impotent and unable to control their bladder.  Dont let this happen to you or your loved ones - take Prostabeta Advance daily! ... Prime Health Direct absolutely guarantee that if you take Prostabeta Advance daily for 6 months, you will experience a significant improvement in prostate health.  No ifs... no buts [sic] ... no qualifiers.  This guarantee is complete, absolute and total!".

7.  "Natural Saw Palmetto extract ... Studies have repeatedly shown its beneficial effects in treating benign prostatic hyperplasia (BPH) ... unlike many pharmaceutical treatments for BPH Saw Palmetto can actually increase libido and male sexual performance".

8.  "HORNY GOAT WEED EXTRACT ... This ancient aphrodisiac works to raise the libido, correct erectile dysfunction, increase energy and stamina, and assist in sperm production ... This action improves libido and sexual desire, sensory stimulation, erectile dysfunction, energy, stamina and sperm production".   

The ASA challenged whether the leaflets:

9.  made medicinal claims for unlicensed products;

10.  discouraged recipients from seeking proper medical treatment for serious medical conditions; and

11.  encouraged consumers to use products to excess, suggested they were guaranteed to work and without side effects.  

CAP Code (Edition 11)

Response

Prime Health Direct did not respond to the ASA's enquiries.

Assessment

Upheld

The ASA was concerned by Prime Health Direct's lack of response and apparent disregard for the Code, which was a breach of CAP Code clause 2.6 (Non-response).  We reminded them of their obligations under the Code and told them to respond promptly in future.

1. - 8. Upheld

We considered that some of the claims made in the leaflet were 'new' or 'breakthrough' claims, and in order to substantiate those and the other claims being made, Prime Health Direct should have submitted a robust body of evidence, consisting of trials conducted on people, to show that the products worked in the way described.  In the absence of such evidence, we concluded that the claims were unsubstantiated and, therefore, likely to mislead.

On this point, the leaflets breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness), 50.1 (Health and beauty products and therapies - general) and 50.20 and 50.21 (Vitamins, minerals and other food supplements).

9. Upheld

We noted the leaflets included claims such as "Only Kreflex can claim to do ALL the following: Enhance cell membranes to stop inflammation ... Help repair ageing and damaged joints in the knees, hips, spine and hands...", "Rosehip ... Who would have thought this natural plant extract could hold the secret to arthritis relief?" and "Prostabeta Advance ... If doctors decide your prostate has become cancerous, your life will be at risk ... Even if the surgery is successful, a huge percentage of men find themselves both impotent and unable to control their bladder.  Don't let this happen to you ... take Prostabeta Advance daily!".   

We considered that a number of the claims listed in the leaflets suggested the products could treat or prevent a disease or restore, correct or modify physiological functions by pharmacological, immunological or metabolic action and were, therefore, medicinal.  We noted we had not seen evidence to show that any of the products had a valid marketing authorisation.  We concluded that the leaflets made medicinal claims to promote unlicensed products and, therefore, breached the Code.

On this point, the leaflets breached CAP Code clause 50.11 (Medicines).

10. Upheld

We noted the leaflets made reference to arthritis, erectile dysfunction and prostate problems, which we considered were serious medical conditions.  We considered that, by making reference to and offering advice on those conditions, the ad could discourage readers from seeking essential treatment for serious medical conditions.

On this point, the leaflets breached CAP Code clause 50.3 (Health and beauty products and therapies - general).

11. Upheld

We noted the leaflets made claims such as "... In collusion with a doctor of urology, we have created a sensational new improved natural choice that combines unprecedented effectiveness with no unpleasant side effects.", "Kreflex ... no known side effects ... very safe at high dosage levels", "Rosehip ... also offers great relief from the pain caused by arthritis and osteoarthritis - without the side effects of anti-inflammatory drugs" and "Prime Health Direct absolutely guarantee that if you take Prostabeta Advance daily for 6 months, you will experience a significant improvement in prostate health.  No ifs... no but's [sic] ... no qualifiers.  This guarantee is complete, absolute and total!".

We considered that the leaflets implied that the products were guaranteed to work and without side effects even at high dosage levels in the case of one product.  Given that we had not seen evidence in support of the efficacy claims of any of the products, or evidence to show that they carried no side effects, particularly when taken at high dosage levels, we concluded that the leaflets could mislead.

On this point, the leaflets breached CAP Code clauses 3.1 (Substantiation) and 50.4 (Health and beauty products and therapies - general).

Action

The leaflets must not appear again in their current form.  We asked CAP to advise its members of the problem with Prime Health Direct.

Adjudication of the ASA Council (Non-broadcast)