Background
Summary of Council Decision:
Two issues were investigated, both of which were Upheld.
Ad description
A website, Amazon listing and two eBay listings by Home Health UK for a breathalyser, seen on 10 February 2017:
a. The eBay listing, stated that the product was “EU Wide approved” and “EU wide certified” and below included a table which provided the drink drive limits for each EU country.
b. The Amazon listing stated that the product was “EU certified” and below included a table which provided the drink drive limits for each EU country.
c. The website, homehealth-uk.com, included a table below the product description which provided the drink drive limits for each EU country.
Issue
AlcoSense challenged whether:
1. the claims “EU Wide approved”, “EU certified” and “EU wide certified” in ads (a) and (b) were misleading and could be substantiated; and
2. the ads misleadingly implied the product was suitable for use in all EU countries, as they understood each country used a different formula for calculating the volume of alcohol in blood from the volume of alcohol in breath and that the product did not account for that.
Response
1. & 2. Home Health UK Ltd stated that the claims “EU Wide approved”, “EU wide certified” and “EU certified” were not misleading. They provided an assessment of the legal requirements of the product by a German notified body for EU medical device regulation. The assessment stated that in the absence of particular regulations or European standards, or inability to apply the standards, the product safety should be assessed with special consideration of national standards, being a transposition of other applicable European or international standards, best practices codes and craftsmanship as well as safety levels expected by consumers.
In the case of disposable alcohol tests, the assessment stated that the applicable standard could be a French test ‘NF X 20-702:2007 - Determination of alcohol content in exhaled air analysis’. That test determined technical parameters and test methods being the reference for chemical alcotests to enable the determination of alcohol content in exhaled air. It also provided guidelines for product marking and user manual contents.
Home Health UK provided a copy of a certificate from a testing body which stated that the product had been tested according to the standards NF X 20-702, June 2007 paragraphs 4.1-4.4 and NF X 20-702 October 2014 paragraphs 6.1-6.5. Home Health UK stated that their product was for sale in the UK to UK customers and contained a table giving the drink driving limits in the rest of the EU which they stated were correct.
Assessment
1. Upheld
The ASA considered that consumers would be likely to understand the claims “EU wide approved”, “EU certified” and “EU wide certified” in ads (a) and (b) to mean that either there was a specific standard that the product should comply with in order to be used across the EU or there were standards set out by individual EU states, and that the product complied with all the relevant EU standards.
Home Health UK provided a report from a notified body stating that for the product to be considered suitable to sell throughout the EU, in the absence of particular regulations and European standards, the product safety should be assessed with special consideration of national standards. The applicable standard in this case was “NF X 20-702”, a French standard which breathalysers carried by drivers in France had to comply with. We were not aware of any other specific national standards in the EU for breathalysers.
Home Health UK provided certification that showed that the product had been tested to the standard NF X 20-702, June 2007 paragraphs 4.1-4.4 and NF X 20-702 October 2014 paragraphs 6.1-6.5. However, the text of the NF X 20-702 stated that in order to meet the standard, the product must be tested against the entire standard rather than a part of it. We contacted the laboratory responsible for administering the NF standard in France, which confirmed that the whole standard needed to be used.
Home Health UK did not provide documentation to show that the device met the other sections of the standard and therefore had not shown that the device met the French national standard for breathalysers. We therefore considered that Home Health UK had not substantiated that the device was “EU Wide approved”, “EU Wide certified” or “EU certified” and concluded that the claims were misleading.
On this point ads (a) and (b) breached CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising) and 3.7 3.7 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. (Substantiation).
2. Upheld
We considered that consumers would understand the claims in ads (a), (b) and the table in ad (c) which displayed the drink driving limits for different European countries to mean that the product was suitable for use throughout Europe and that the product would give an indication of the level of alcohol in their blood based on a breath sample.
Ads, (a), (b) and (c) each gave measurements of alcohol in blood in blood metric of g/L. They also stated that the product was “a disposable breathalyser used to measure blood alcohol content from a breath sample”. Ads (a) and (c) both stated that “Test Drive results will be reliable if used correctly” and also that “Test & Drive is designed for personal use and is not approved for official blood alcohol content measurement. The blood alcohol content readout may not be used as evidence and in particular to demonstrate being/not being intoxicated after consuming alcohol”. We considered that consumers would understand from these statements in ads (a), (b) and (c) that they should be able to rely on the device to provide a sufficiently accurate measure of blood alcohol content from a breath sample, to inform their decision about whether they were safe to drive, taking into account local drink driving limits. The image of the product in ads (b) and (c) also featured writing on it which stated “Accuracy over 98%”. We considered that consumers would interpret this to mean that the product would produce an accurate reading of the level of alcohol in blood, in any country in Europe, of over 98%.
Documents referred to by the complainant suggested that different EU countries used different values to calculate blood alcohol from breath samples. We noted that the French and UK government published separate limits for blood alcohol and alcohol in breath. We also noted from these same sources that although Scotland and France held the same limit for alcohol in blood, they held different limits for alcohol in breath, which showed that they used different ratios to calculate blood alcohol from the level of alcohol measured in breath. Because the ads said that the product gave a reading in g/L, a measure of alcohol in blood, if it was set to the French standard as implied by the ads, it would therefore be more accurate in France than in Scotland, and that would also apply to other countries which used different ratios to calculate blood alcohol from breath samples. Because we considered that the claims in ads (a), (b) and (c) implied that the product could be used in any European country and would give an accurate reading, when that was not the case, and did not make the varying accuracy levels clear within the ad, we concluded that the ad was misleading.
On this point the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
and
3.3
3.3
Marketing communications must not mislead the consumer by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that the consumer needs to make informed decisions in relation to a product. Whether the omission or presentation of material information is likely to mislead the consumer depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the marketer takes to make that information available to the consumer by other means.
(Misleading advertising) and
3.7
3.7
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.
(Substantiation).
Action
The ads must not appear again in its current form. We told Home Health UK Ltd not to state or imply that their product had been “EU Wide approved”, “EU Wide certified” or “EU certified”, unless they held new evidence that this was the case. We told Home Health UK Ltd not to imply that the product was equally suitable for use in any European country.
