An ad for a dry salt inhaler from Vytaliving, seen in The Daily Express newspaper on 4 April 2020, featured the headline “Breathe Easy with MICRO Miracle Pure Breather”. Text above the title listed: “ALLERGIES”; “SINUS/BRONCHITIS”; “SMOKERS COUGH”; “LACK OF MOBILITY”; and “PROMOTES HEALTHY LUNGS”. Alongside an image of a woman using the inhaler, further text stated “50% off”, “100% NATURAL DRY SALT CRYSTALS have been used for centuries for their natural healing and health benefits” and “The amazing health benefits can now be found in this micro-sized inhaler than fits into your pocket. You can now benefit from the amazing benefits anytime in any place”. Text next to an image of the product stated “Give your lungs an extra boost! Natural relief from respiratory issues such as” followed by bullet points: “Allergies; Sinus/Bronchitis; Smokers Cough; Lack of Mobility; Age Related Conditions; Natural Relief (oral); Safe and effective; Compact, Natural dry Salt Inhaler; Lasts up to 3 months”.
Images of two women were featured, alongside their testimonials, which stated “This amazing little device gives my lungs an extra boost when they need it. I feel relaxed, rested and ready to get on with my day … I was so impressed with the Miracle Pure Breather that I bought one for my husband too” and “It’s like being next to the fresh ocean air”.
Further text below stated “BUSINESS AS USUAL – UK STOCK READY TO SEND” and included details to order the product by phone, online and by postal order.
IssueThe complainant challenged whether the efficacy claims for the medical conditions listed in the ad were misleading and could be substantiated.
ResponseBioenergiser Ltd t/a Vytaliving said that the product was a certified Class I medical device which was in the process of being assessed through clinical studies. They said that an on-going study been put on hold due to the COVID-19 pandemic. They provided one study as evidence. Bioenergiser said that they would not advertise the product through the press in the future.
The ASA acknowledged that the product had been CE-marked as a class I medical device. Class I medical devices were generally CE-marked on a self-declaration basis. CE certification in itself did not constitute evidence for medical efficacy claims, and advertisers needed to ensure that they held evidence for such claims.
The ad made a number of claims including “Give your lungs an extra boost! Natural relief from respiratory issues such as Allergies, Sinus/Bronchitis, Smokers Cough, Lack of Mobility, Age Related Conditions, Natural Relief (oral)”, and “PROMOTES HEALTHY LUNGS”, as well as two testimonials which included the claims “gives my lungs an extra boost when they need it” and “It’s like being next to the fresh ocean air”. We considered that consumers would understand these claims to mean the product would be able to relieve the symptoms of the respiratory conditions listed as well as generally improve lung function.
We therefore required Bioenergiser to provide evidence to support the claims made in the ad, including the testimonials. They provided the results of an unpublished double-blind, randomized, single-crossed clinical trial with 21 patients, which evaluated the effects of inhaled dry salt in stages 2 and 3 Chronic Obstructive Pulmonary Disease (COPD) patients and patients with asthma, in improving lung function. The clinical trial was not relevant to the claims made in the ad because it did not measure the product’s efficacy in relieving the respiratory conditions listed.
The study had a crossover design whereby the two groups alternated between using a dry salt inhaler and a placebo inhaler, and therefore acted as their own controls. The results showed an improvement in measurements of breathing capacity and flow and quality of life in the treatment periods versus the placebo periods. However, the conclusion of the study acknowledged that the magnitude of the changes was relatively small. The sample size was relatively small, with no power calculation provided, and details of group demographic characteristics and the follow-up process were also missing. Furthermore, the study had not been subject to peer review. We had not seen adequate evidence to substantiate that the product could relieve allergies, sinus issues, bronchitis, or smokers’ cough, or generally improve lung function.
We therefore concluded that the ad was misleading and breached the Code. The ad breached CAP Code (Edition 12) rules
Marketing communications must not materially mislead or be likely to do so.
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease. (Medicines, medical devices, health-related products and beauty products).
The ad must not appear again in its current form. We told Bioenergiser Ltd t/a Vytaliving not to make efficacy claims to relieve respiratory issues, such as allergies, sinus issues, bronchitis, or a smokers cough, or make claims about improving lung function generally unless they held adequate evidence to substantiate such claims.