The UK Advertising Standards Authority (ASA) has upheld 7 of the 8 complaints against the Ainsworth Homeopathic Pharmacy over a leaflet for holiday goers (since withdrawn from circulation) in which the Pharmacy presented a certain number of claims concerning the efficacy of homeoprophylaxis (homeopathic disease prevention). The ASA warned the Pharmacy not to advertise unlicensed homeopathic products in future and to make certain claims for licensed homeopathic products did not exceed those claims allowed by law.
The ASA understood that the leaflet was intended to be supplemental to travel advice given in person by Ainsworths staff. We considered, however, that the oral information was unlikely to contradict the claims made for homeoprophylaxis in the leaflet and we noted that the leaflet could be retained by individuals and the travel kit could then be bought on the company’s website at a later date. We acknowledged that Ainsworths staff was trained to advise customers to first pursue conventional options available from their physician. We noted that the leaflet had been withdrawn.
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We understood that adverse reactions to conventional vaccines could occur in some individuals and we noted the terms of the BMJ article and the other resources that Ainsworths referred to. We understood that homeopathic products were generally designed to be ingested, rather than delivered directly into the bloodstream, and that they had been shown to have no side-effects. We considered, however, that readers would infer from the leaflet as a whole that homeopathic products were viable alternatives to conventional holiday vaccines and that they were in fact preferable because they were safer and less invasive. We noted that the leaflet did not state that customers should follow conventional vaccination opportunities first unless there was specific reason not to do so. We therefore considered that the leaflet was irresponsible, because it was likely to discourage readers from seeking medical advice regarding conventional vaccination against serious infectious diseases.
On this point the leaflet breached CAP Code (Edition 12) rules 1.3 (Social responsibility), 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1, 12.2 and 12.6 (Medicinal claims).
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We considered that, by making reference to serious infectious diseases such as typhoid, tetanus, polio, meningitis, Japanese encephalitis and malaria, the leaflet implied homeopathic products were effective in treating those conditions. We considered that Ainsworths had not provided sufficiently robust scientific evidence to support the implied claim and we concluded that the leaflet was therefore misleading and irresponsible, because it could discourage readers from seeking medical advice regarding conventional vaccination against serious infectious diseases.
On this point the leaflet breached CAP Code (Edition 12) rules 1.3 (Social responsibility), 3.1 (Misleading advertising), 3.7 (Substantiation), 3.11 (Exaggeration) and 12.1, 12.2 and 12.6 (Medicinal claims).
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We noted that the disclaimer “Since these products have not been tested in clinical trials we are unable to make claims for the effectiveness of this method of disease prevention” was immediately qualified by the statement that Ainsworths relied instead on the testimony of those that had used the products “successfully throughout the world”. We considered that the statement contradicted the disclaimer and implied a widespread acceptance of the effectiveness of the products in non-clinical conditions. We had not seen evidence to suggest that such broad acceptance of the effectiveness of these products existed. In the context of a leaflet that referred to serious infectious diseases, we considered that the disclaimer, which was immediately qualified, was insufficient to make readers suitably aware of the limitations of the advertised products. We concluded that the leaflet was misleading and irresponsible, because it could discourage readers from seeking medical advice regarding conventional vaccination against serious infectious diseases.
On this point the leaflet breached CAP Code (Edition 12) rules 1.3 (Social responsibility), 3.1 (Misleading advertising), 3.7 (Substantiation), 3.9 (Qualification) and 12.1, 12.2 and 12.6 (Medicinal claims).
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We accepted that some homeopathic products were licensed by the MHRA and that homeopathy was an established part of the NHS. We therefore considered that it was appropriate to use terms such as “dose”, “tablet”, “exposure” and “active cases” in relation to homeopathic products.
On this point we investigated the leaflet under CAP Code (Edition 12) rules 3.1 and 3.6 (Misleading advertising), 3.7 (Substantiation) and 12.1, 12.2 and 12.6 (Medicinal claims) but did not find it to be in breach.
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We considered that the claims made in relation to Chelidonium 6X, Ceanothus 6X and the “Anti-Bite Tincture” implied that those three remedies had a physiological effect on the body and were effective for the medicinal uses stated in the leaflet. We understood that these were natural substances that would be made into a finished product at a customer’s request but we did not consider that this effected Ainsworths obligation to provide scientific evidence to substantiate the claimed medicinal uses; and they had not provided scientific evidence to support the claims made. Furthermore, we had not seen evidence from Ainsworths that they held an MHRA marketing authorisation for Chelidonium 6X, Ceanothus 6X or the “Anti-Bite Tincture”. We therefore considered that the leaflet had made unsubstantiated medicinal claims for unlicensed products, which was a breach of the code, and that it was misleading.
On these points the leaflet breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), 3.11 (Exaggeration), 12.1, 12.2 and 12.6 (Medicinal claims) and 12.20 (Homeopathic medicinal products).
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We noted that the MHRA had issued a marketing authorisation for Apis 30C but that there were no approved indications for the product. We considered that the product information given in the leaflet should therefore have been confined to what appeared on the product label. We had not seen evidence from Ainsworths that they held a marketing authorisation for Histamine 200x. We concluded that the leaflet made unauthorised medicinal claims in respect of both products, which was a breach of the Code, and that it was misleading.
On this point the leaflet breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), 3.11 (Exaggeration), 12.1, 12.2 and 12.6 (Medicinal claims) and 12.20 (Homeopathic medicinal products).
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We noted that the travel kit contained remedies for minor ailments only, but we considered that the leaflet implied the travel kit contained the homeoprophylaxis remedies that had been mentioned and that it had recommended those products as an alternative to conventional vaccinations for the purpose of protecting customers against serious infectious diseases. In that context, we considered that reference to the products as “indispensible” and “important” reinforced the impression that the remedies mentioned were effective in preventing those diseases. We also considered that it implied the products were an essential purchase for those travelling abroad, which we concluded was irresponsible, because it could discourage readers from seeking medical advice regarding conventional vaccination against serious infectious diseases.
On this point the leaflet breached CAP Code (Edition 12) rules 1.3 (Social responsibility), 3.1 and 3.6 (Misleading advertising), 3.11 (Exaggeration), 12.2 and 12.6 (Medicinal claims) and 12.20 (Homeopathic medicinal products).
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We understood that the leaflet had already been withdrawn. We told Ainsworths to ensure in future that no marketing communications referred to serious medical conditions. We told them no medicinal claims should be made for unlicensed homeopathic products and that medicinal claims for licensed homeopathic products should not include indications other than those allowed by the MHRA marketing authorisation.
Note that in the United States, the federal government regulates homeopathic medicines in the same manner as OTC (over the counter) medicines. See here for more information.
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