ASA Adjudication on Pinnacle Health Ltd
Pinnacle Health Ltd t/a
2nd Floor Osprey House
5-7 Old Street
7 January 2009
Health and beauty
Number of complaints:
A mail order catalogue, for Simply Supplements, titled "A Healthy Beat in Your Heart" included claims for a number of products: Co Enzyme Q10, Ginger, Ginkgo Biloba, Feverfew, Echinacea and Omega 3.
The Health Food Manufacturer's Association (HFMA) challenged whether the following claims were misleading and could be substantiated.
In relation to Co Enzyme Q10:
1. "Co Enzyme Q10 is essential in helping to keep a healthy heart, as well as keeping energy up to optimum ability"; and
2. "Trials showed that there was a drop of up to 75% of Co Enzyme Q10 cells in the heart of congestive heart failure patients, which suggests taking this nutrient can help quite effectively with this disease."
In relation to Ginger 700 mg and Super Strength 12000 mg:
3. "Ginger extract can help to reduce arthritis pain and stiffness";
4. "During a clinical trial, after only six weeks of treatment, Ginger extract patients showed nearly twice as much improvement in mobility and 63% had reported reduced stiffness"; and
5. "Our natural ginger supplement offers an effective and safe means of treating joint pain and stiffness without the side effects associated with conventional pain killers."
In relation to Ginkgo Biloba:
6. "Clinical trials have shown that supplementing Ginkgo Biloba can reverse the decline in cognitive function that often accompanies ageing";
7. "A preliminary study ... suggests leaf extracts of the Ginkgo Biloba tree may help prevent Alzheimer's disease";
8. "Ginkgo has long been known to improve brain (cognitive) function in older people and to favorably influence other signs of aging"; and
9. "Ginkgo has also been reported to improve other age-related problems, including ringing in the ears (tinnitus), vertigo, headaches, mood disturbances, erectile dysfunction, macular degeneration (an eye condition that results in loss of vision), and intermittent claudication (leg pain on walking caused by hardening of the arteries)".
In relation to Feverfew:
10. "Recent research has studied Feverfew for its ability to prevent severe migraine and headaches. Clinical studies have provided preliminary evidence that Feverfew may be able to prevent both the frequency and severity of migraines".
In relation to Echinacea 100 mg and Super Strength 3200 mg:
11. "Echinacea increases production of interferon, an important part of the body's response to viral infections such as cold and flu"; and
12. "Recent research has found that taking the herbal remedy can reduce the risk of catching the common cold and flu by more than half - Echinacea reduced the risk by 65% and the duration of colds by one and a half days."
The ASA challenged whether:
13. the catalogue made medicinal claims for unlicensed products; and
14. the claim in relation to Omega 3 was misleading and could be substantiated: "It can help a child's brain development, and has shown positive results in scientific trials so far. It is thought to help improve concentration, mood and learning ability".
CAP Code (Edition 11)
1. Simply Supplements said they believed substantial evidence existed which showed that Co Enzyme Q10 was essential to keeping a healthy heart. They nevertheless stated that they were unable to provide documentary evidence due to time constraints and would therefore remove the claim from further literature.
2., 3., 4., 5., 6., 7., 8., 9., 10., 11., 12. & 14. Simply Supplements reiterated that, due to time constraints, they were unable to provide the documentary evidence requested. They said the claims would be removed from further literature.
13. They said, as a Guernsey-based company, the reference to medicinal claims was not relevant to them because the Medicines and Healthcare Products Regulatory Agency (MHRA) had no jurisdiction in the Channel Islands. They nevertheless understood Guernsey legislation would be aligned with MHRA guidelines in the future.
1.-12. & 14. Upheld
The ASA noted Simply Supplements had been unable to provide evidence due to time constraints. We were concerned by this as marketers should hold documentary evidence to prove all claims before submitting a marketing communication for publication. We did not therefore consider that that was a satisfactory reason for failing to provide substantiation.
We noted Simply Supplements believed the claim about Co Enzyme Q10 could be substantiated but did not submit evidence of that or the other claims in the ad.
We considered that some of the claims being made were new or breakthrough claims, and in order to substantiate these and the other claims being made, Simply Supplements should have submitted a robust body of evidence, consisting of trials conducted on people, to show that the vitamins and supplements worked in the way described. In the absence of such evidence, we concluded that the claims were misleading.
On these points, the catalogue breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness), 50.1 (Health and beauty products and therapies - General), 50.20 and 50.21 (Vitamins, minerals and other food supplements).
We noted the brochure included claims such as "Clinical trials have shown that supplementing Ginkgo Biloba can reverse the decline in cognitive function that often accompanies aging." and "Echinacea increases production of interferon, an important part of the body's response to viral infections such as cold and flu". We considered that a number of the claims listed in the catalogue 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 Simply Supplements' point that, as a Guernsey-based company, they were not within the MHRA's jurisdiction and they therefore believed they could make medicinal claims. We noted however the Channel Islands were subject to the CAP Code which stated that medicinal claims should not be made for unauthorised products. Although we noted Simply Supplements' point that Guernsey legislation would be aligned with MHRA guidelines in the future, we considered that, until such time, the products were unlicensed and medicinal claims should not be made for them.
On this point, the catalogue breached CAP Code clauses 50.11(Medicines).
The catalogue must not appear again in its current form. We told Pinnacle Health to remove the claims set out at points 1-12 and 14 from their future catalogues and to ensure that they did not make medicinal claims for unauthorised products. We advised them to contact the CAP Copy Advice team for guidance with future marketing material.
Adjudication of the ASA Council (Non-broadcast)