A radio advertisement for Higher Nature stated:
“If you suffer from asthma, hay fever or chronic snoring then the salt pipe from Higher Nature may be the solution.
The salt pipe is an easy to use respiratory aid which offers the benefits of portable salt therapy, clinically proven to cleanse the lungs and thin mucus significantly.
Available from health stores and pharmacies nationwide.”
The complainant considered that the advertisement had made unproven medical claims.
The distributor, Wholefoods Wholesale, stated that they invested a lot of resources in screening their suppliers and their products to ensure that they were compliant with EU and National regulations. The product in question was supplied to them by Higher Nature in the UK and had been assessed and certified as a medical device Class IIA throughout Europe and as such, in Ireland by Oxford Medical Instruments and had fulfilled all the essential and other requirements put forward in Directive 93/42/EEC. They provided a copy of all up to date certificates to ASAI.
In regards to the complaint, they stated that a study on the evaluation of clinical data from salt therapy and medical applications of salt inhalation therapies was commissioned by Oxford Medical Instruments based on the coordination issued by the notified bodies of medical devices with respect to Council Directives 90/385/EEC (AIMD), 93/42/EEC (MDD) and 98/79/EC in 2012. They said that one of the findings of this study stated “Due to their particle size, inhaled salt grains can penetrate even the farthest, narrowest sections of airways, and after dissolving in the mucus covering the airway surface they induce processes that promote improvement of the patient’s condition. The dissolved salt increases the osmolarity of mucus, resulting in an efflux of water into the airways, diluting and thinning the mucus, thus easing its removal. This is important because, as described above, clogged airways and colonising and proliferating pathogens are responsible for the exacerbation of the patient’s condition.”
They also said that other clinical trials had been carried out by Hovrath 1986, Chervinskaya 2002 and Szelely & Co-Workers 2004, all with similar findings. They forwarded a copy of the trials for information.
Finally, they stated that they were happy with the bona fides of their supplier and that the product they were marketing in Ireland, to the best of their knowledge and experience, was not in breach of any regulatory requirements or codes of practice.
The ASAI Secretariat requested an independent expert, with a science background, to review the complaint and the advertisers’ response. The expert reviewed the details of the case and provided the following advice:
“The claims made regarding the use of the saltpipe in patients with asthma has some basis in literature. However, snoring is experienced by between 16% and 85% of the general population depending on definitions used. To maintain without evidence that the device may have a positive impact on those who snore is misleading and without foundation in the documentation submitted. Claims regarding the Saltpipe’s utility in hay fever require further clarification and have the potential to mislead.”
The Secretariat then provided the advertisers with a further period of time to provide substantiation for the claims regarding chronic snoring and hay fever. They asked that they either provide substantiation for these claims or refrain from using them in their marketing communications.
The advertisers failed to respond further in the matter.
Complaint upheld in part.
The Complaints Committee considered the detail of the complaint and the advertisers’ response. The Committee also noted the opinion provided by the independent expert. The Committee did not consider that sufficient evidence had been provided for the claim regarding chronic snoring or hay fever and therefore considered this aspect of the advertisement to be in breach of Section 8.1 of the Code.
In regards to the claims regarding chronic snoring and hay fever, the Committee told the advertiser not to repeat the claims in the absence of evidence to substantiate them.