ASA Adjudication on Church & Dwight UK Ltd

Ad

A magazine and a radio ad for the First Response Early Result Pregnancy Test appeared in September and October 2010:

a. The magazine ad featured an image of the First Response test result showing two pink lines, above text that stated “Yes, you’re pregnant”, and an image of a digital test result showing the words "Not pregnant", above text that stated “Can’t tell, try me again in a couple of days". Further text stated “Unlike digital pregnancy tests we operate on a 'you need to know basis' All pregnancy tests are not created equal. Only First Response detects the pregnancy hormone 6 days before your missed period.* Digital tests can’t say that”. The ad included an image of the product packaging, which featured the text “TELLS YOU FIRST... 6 DAYS EARLY*” and “Over 99% Accurate!**”. Small print at the bottom of the ad stated “*Always read the leaflet. 62% could get accurate results 6 days before day of missed period (5 days before period due)”.

b. The radio ad stated “Pregnant? Can’t wait to find out? Only First Response detects the pregnancy hormone six days before a missed period. With First Response the definitive sign is a pink line ... Always read the leaflet. 62% could get accurate results six days before the day of the missed period five days before period due.”

Issue

SPD Swiss Precision Diagnostics GmbH (SPD) objected that:

1. The claims "6 days before your missed period", "6 DAYS EARLY" and "6 days before day of missed period" in ad (a), and "six days before a missed period" and "six days before the day of the missed period" in ad (b), misleadingly implied the First Response pregnancy test was accurate six days before a period was due, and the small print in the magazine ad and the statement in the radio ad, "five days before period due", were therefore likely to be seen as contradictory and confusing. They believed consumers would expect the day of the missed period to be the day the period was due, and would not expect the six days to have been measured by counting backwards from the day after the day that the period was due.

2. Ad (a) misleadingly implied that the test was "Over 99% Accurate!**" six days before the day of the missed period, which was contradicted by the small print "62% could get accurate results 6 days before day of missed period", and the ad did not make clear that the test was "Over 99% Accurate!**" one day before the period was due but no earlier than that.

3. The claim in ad (a) "Can't tell, try me again in a couple of days" misleadingly implied the First Response test could register accurate results for pregnant women two days before digital pregnancy tests could, whereas it could register accurate results for pregnant women only one day before their own digital pregnancy test could.

4. The claim in ad (a) "Over 99% Accurate!**" was misleading and could be substantiated, because they believed it implied the product would have that level of effectiveness in ascertaining whether a woman was pregnant or not, whereas they understood the claim related only to the products accuracy in detecting the pregnancy hormone rather than to its accuracy in terms of a not pregnant result. They also believed the rate of effectiveness could be affected by false positive results for some peri-menopausal women.

CAP Code (Edition 12)

BCAP Code

Response

1. Church & Dwight UK Ltd (C&D) said they were confident that the phrase "date of missed period" was well understood by consumers, because it was logical that a woman could not be said to have 'missed' her period until it had failed to arrive, until which point it was 'due'. They said, for example, if a student had to submit an essay between 12 pm and 1 pm, they could not be said to have missed the deadline until after 1 pm. They said a woman who had a regular menstrual cycle expected her period at any point during the 'due date' and, while she might feel anxious if it did not arrive in the morning, she would know it might arrive later in the day. C&D said it was only if her period did not arrive by the following morning that the woman would know she had missed her period and therefore that date would be considered to be the day of the missed period. They said the ads also explained the concept of a "missed period" with the footnote " ... 6 days before day of missed period (5 days before period due)" in ad (a) and the voice-over " ... six days before the day of the missed period five days before period due" in ad (b).

They believed reference to either date would have been sufficient, because both were understood by the majority of their target customers, however they were happy to refer to both the due date and the day of the missed period to allow consumers to use the kit by reference to whichever date was more convenient and comfortable for them. They believed it was preferable to refer to both dates, rather than only the day of the missed period, because it was helpful to consumers and avoided any potential confusion. C&D said there had not been any complaints from consumers about their advertising; they strongly believed consumers would not be misled by the ads.

In relation to ad (b), the RACC said they believed the qualifying statement "six days before the day of the missed period five days before period due" addressed concerns raised in previous ASA adjudications, that consumers could interpret the claim to mean that the product could tell them if they were pregnant six days before the date their period was due. They said the statement was clearly audible and listeners would understand that the product gave results six days before the period did not arrive, which equated to five days before the due date.

2. C&D said they strongly disagreed that the "99% Accurate" claim was misleading or required amendment. They said modern consumers were accustomed to viewing ads and interpreted advertising statements in the context of that experience. They said, in particular, where statistics were included in marketing material, consumers would look for an explanation of the basis and would not expect such statistics to have blanket applicability. They said the small print in the ad clearly set out the basis of the claim: that the accuracy of the kit increased the closer to the day of the missed period it was used. They said that would not be surprising to consumers, because the kit was an early results product by nature. They said they would, however, be prepared to amend the small print to provide further detail in relation to the claim.

3. C&D said the statement "Can't tell, try me again in a couple of days" was intended to be colloquial and to emphasise that in certain circumstances, the kit was the only product on the market that could provide an accurate result. They said it was not intended to suggest there was a two-day difference between the performance of the product and that of its nearest competitor. They said they had since amended the text to "Can't tell, try me again later", which they hoped would rectify any concerns.

4. C&D said the kit was over 99% accurate in both detecting the pregnancy hormone and in determining whether or not a woman was pregnant. They said when a fertilised egg was implanted in the wall of the uterus, it secreted the hormone human chorionic gonadotropin (hCG). Home pregnancy kits used antibodies to test for the presence of hCG and any hCG that was present in urine would react with the antibodies to give a 'pregnant' result. They said the effectiveness of the kit in detecting the pregnancy hormone was known as 'analytical accuracy' and that had been the subject of many tests by C&D, using urine samples from pregnant and non-pregnant females. C&D said the claim therefore accurately referred to the kit's analytical accuracy in detecting hCG in the urine of users.

They said in certain cases the kit accurately detected the presence of hCG but in circumstances where the user was not pregnant, which was known as a false positive. A false positive could be caused by several factors, such as a chemical pregnancy, where the user had miscarried but hCG was still present, by chemical interference, for example when the user was undergoing fertility treatment that contained hCG, or if the user was a peri-menopausal woman. C&D said in peri-menopausal women a certain amount of hCG was produced naturally by the pituitary gland. They said the ability of the kit to detect whether the user was pregnant was known as its 'clinical accuracy', which had also been the subject of studies. In one study, conducted in December 2009, 300 subjects were enrolled and provided daily urine samples around the time of their expected periods. Of the 300 subjects, 200 were clinically non-pregnant and 100 were clinically pregnant. They said the data generated from the studies conclusively demonstrated that the accuracy of the kit to detect whether or not a woman was pregnant was greater than 99% at around the time of the expected period, which supported the "Over 99% Accurate!**" claim.

They said they had also carried out tests in 2007 on peri-menopausal subjects aged 41 to 55 years, in which the observed false positive rate was found to be 4.17%. They said, however, intended users of the kit were fertile women of childbearing age and the percentage of peri-menopausal users within the population of fertile women of childbearing age was less than 10%. C&D said when the data from the test was extrapolated, the rate of false positives across the entire intended user population would be 0.42%. That meant the rate of accuracy for the population as a whole was 99.58%. They said that in the 2009 test the 200 non-pregnant women were further sub-divided by age, including 10% of the cohort being peri-menopausal women aged 41 to 55 years, and the results of that study also demonstrated the ability of the kit to accurately detect whether a woman was pregnant was around 100% at the time of the expected period. They said as the ads stated, as would be expected, the clinical accuracy of the kit decreased the earlier it was used.

C&D submitted the studies as well as a memo related to the extrapolation of results related to peri-menopausal women to the wider target population. They said the claim was not misleading and it applied to both the kit's detection of the pregnancy hormone and to its accuracy in determining whether or not a woman was pregnant.

Assessment

1. Upheld

The ASA noted that the ads had been amended as a result of previous ASA adjudications. We also noted that those adjudications concluded that the difference between the day the period was due and the day of the missed period might not be immediately clear to consumers, and that the previous ads were misleading because some consumers might interpret the claims to mean that the product could tell them if they were pregnant six days before the date their period was due, when that was not the case.

We acknowledged that C&D had amended the ads to include the footnote " ... 6 days before day of missed period (5 days before period due)" in ad (a) and the voiceover " ... six days before the day of the missed period five days before period due" in ad (b). We considered, however, that did not go far enough to clarify the ambiguity of the phrase "missed period" and was likely to cause confusion for viewers about the performance of the product. We considered viewers might understand that if their period did not come on the day it was due that would be the day of the missed period, rather than the day after, and we therefore considered the ads could still be interpreted to mean the product could tell viewers if they were pregnant six days before the date their period was due. We considered that impression was reinforced by the text "... TELLS YOU FIRST ... 6 DAYS EARLY*" in the pack shot in ad (a). We considered the ads should have explained clearly and prominently what was meant by "missed period" and "day of missed period" so viewers could easily understand how early the product could be used. Because they did not, we concluded that the ads were misleading.

On this point, ad (a) breached CAP Code (Edition 12) rules 3.1 and 3.3 (Misleading advertising), 3.9 and 3.10 (Qualification). Ad (b) breached BCAP Code rules 3.1 and 3.2 (Misleading advertising) and 3.10 and 3.11 (Qualification).

2. Upheld

We noted the claim "Over 99% Accurate!**" was qualified by the text "62% could get accurate results 6 days before day of missed period". We considered, however, the qualification was ambiguous and contradicted the claim that the product was 99% accurate. We considered consumers were likely to interpret the claim to mean that the product was 99% accurate when used from the earliest time described in the ad. Because that was not the case, we concluded that the claim was misleading.

On this point, ad (a) breached CAP Code (Edition 12) rules 3.1 and 3.3 (Misleading advertising) and 3.9 and 3.10 (Qualification.

3. Upheld

We noted C&D had amended the claim. We considered, however, the text "Can't tell, try me again in a couple of days" was likely to be interpreted as suggesting that the product was effective two days sooner than digital tests. Because that was not the case, we concluded that the claim was misleading.

On this point, ad (a) breached CAP Code (Edition 12) rules 3.1 and 3.3 (Misleading advertising) and 3.38 (Other comparisons).

4. Not upheld

We noted the studies submitted by C&D. The study conducted in 2007 involved only women who were not pregnant. The results indicated a false positive result for 4.17% of the cohort of peri-menopausal women and for greater than 1% of the total study population. We were therefore concerned that the results of that study did not support the "Over 99% Accurate!**" claim. We were also concerned that the memo related to the extrapolation of the results for peri-menopausal women to the wider target population was dated after the ad appeared, whereas the Code stated that advertisers must hold documentary evidence in support of a claim before an ad appeared.

We also noted the study dated 2009 that involved both pregnant and non-pregnant subjects, which included a proportion of peri-menopausal women; that proportion was based on studies on the age demographics of women who bought pregnancy tests. That study demonstrated that the incidence of incorrect test results, including false negative results for women who were pregnant, false positive results for women who were not pregnant and results for the peri-menopausal cohort, supported a claim that the kit was "Over 99% Accurate!**" in determining whether or not a woman was pregnant around the time of the expected period. We considered the results of the more recent study supported the claim and therefore concluded that it was not misleading.

On this point, we investigated ad (a) under CAP Code (Edition 12) rules 3.1 (Misleading advertising) and 3.7 (Substantiation) but did not find it in breach.

Action

The ads must not appear again in their current form. We told C&D that if they wished to continue making claims based on 'the day of the missed period' they should explain clearly in the body copy of the ad what was meant by "missed period" and "day of missed period". We also told them to ensure qualifying text did not contradict claims in future and to ensure future advertising did not include misleading claims.

Adjudication of the ASA Council (Broadcast)

Adjudication of the ASA Council (Non-broadcast)