Who: Boots UK Ltd (“Boots“), Advertising Standards Authority (“ASA“)
When: 11 November 2015
Law stated as at: 9 December 2015
Boots has recently been the subject of an ASA adjudication in relation to its poster, shown on the London Tube, for its “COLD & FLU DEFENCE Nasal Spray” product. The poster stated that the nasal spray was “clinically proven to defend against cold and flu”. The nasal spray was an approved EU Class IIa medical device as it provided a physical barrier to the virus rather than destroying it.
Under Rule 3.7 of the CAP Code marketers must hold documentary evidence to substantiate any objective claim, such as “clinically proven to defend against cold and flu”. Rule 12.1 of the CAP Code states that, in relation to medical devices, “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”.
Boots submitted a lengthy response citing technical, non-clinical and clinical data aimed at supporting their claim. In summary, Boots claimed that the nasal spray contained ioto-carrageenan and kappa-carrageenan which formed a physical barrier when applied to the nasal cavity. The viral infections that were the most common causes of cold and flu would, they submitted, become attached with the carrageenan and therefore would not enter the body’s cells.
Boots referred to a number of different studies which, they stated, showed that the product was effective in “defending” (i.e. resisting attack) from cold and flu as the fluid formed a barrier and prevented the virus from entering cells and being released into the body.
After consideration, however, the ASA held that the term “defend against”, although not a claim that the nasal spray would prevent colds, suggested to consumers that it had a prophylactic effect and would actively fend off colds and flu. They held that Boots had not submitted sufficient evidence to robustly prove this claim.
Although the ASA agreed that the claim was based on the carrageenan included in the nasal spray, the clinical trials relied upon by Boots were not in the regulator’s view sufficient to prove that this was effective in preventing and treating colds and flu.
The ASA therefore held that the claim that the nasal spray was “clinically proven to defend against cold and flu” was misleading.
Why this matters:
This decision underlines the importance of clinical studies when making objective claims for medical devices. Marketers must ensure that these are robust enough to support any associated claim.
This is reinforced by the ASA’s guidance on substantiation of claims for medical devices which stresses that a body of evidence submitted to support a claim should include at least one adequately controlled experimental study. If the body of evidence that does not include at least one of these, then “the ASA’s or CAP’s experts will usually need to be convinced of the soundness of the data provided and the futility or impracticality of commissioning an experimental human study.”
A final point to note is the need for care when devising product names which arguably contain innate objective efficacy claims. This may not necessarily be the case here, but a decision like this could in some circumstances make it advisable to undertake a not inexpensive renaming process.