Church & Dwight UK Ltd Wear Bay Road Folkestone Kent CT19 6PG Number of complaints: 1

Date: 1 October 2008 Media: Television Sector: Health and beauty Agency: Media Therapy

Ad
A TV ad, for a pregnancy test, featured a woman saying "Am I really pregnant?"; a voice-over stated "For the first time it's possible to find out six days earlier than your missed period. First Response early pregnancy test tells you first". The ad showed a picture of the packaging which stated "TELLS YOU FIRST ... 6 DAYS EARLY"; text at the bottom of the screen stated "Always read leaflet. 62% could get results 5 days before expected period".

Issue
SPD Swiss Precision Diagnostics GmbH (SPD) objected that the claim "... it's possible to find out six days earlier than your missed period" misleadingly implied the product was effective six days before the day the period was due, whereas the on-screen text stated it was only effective five days before the day the period was due. They believed all other pregnancy tests in the UK referred to "the day the period was due" rather than "the day of the missed period".

BCAP TV Advertising Code:

5.2.1;5.2.2;5.4.6;5.1

Response
Church & Dwight UK (C&D) said their advertising for the First Response pregnancy test kit was based on facts obtained from clinical data and evidence concerning the use of the test kit. They asserted that the claims made in the ad were directly derived from their application to their notified body for enhanced chemistry and product performance claims in packaging as part of obtaining a "conformity assessment" and a CE mark under EC law. They said the on-package claims concerning testing before the missed period were intended use statements related to the actual performance of the pregnancy test kit. They said the performance of the product was supported by extensive laboratory and clinical data which had been evaluated by their notified body (TUV Rheinland) as required by the In-Vitro Diagnostics Directive (IVDD) 98/79/EC. They said TUV Rheinlands evaluation determined that the device met the Essential Requirements of the IVDD for the consumers safe and effective use of the product as intended for the detection of the hormone associated with pregnancy before a womans menses.  They said performance criteria were provided to TUV Rheinland as part of the dossier of information they submitted to demonstrate conformity to the Essential Requirements of the IVDD and those performance criteria were stated on the outer packaging of the First Response product, in particular for pregnancy detection "as early as six days before day of missed period".

C&D said the claims used on the outer packaging and in the ad were the same as the "performance" claims reviewed by TUV. They argued that TUV's assessment that the First Response Product conformed with the Essential Requirements of the IVDD (which included that "each device must be accompanied by information needed to use the device safely taking into account of the training and knowledge of the potential user") and the resulting granting of the CE mark, demonstrated that the claims on the outer packaging and in the ad were truthful and substantiated and were therefore not misleading.  

C&D believed the six day intended use statement was substantiated and was clarified by the text on the bottom of the screen. They argued that the ad and the packaging made clear that a consumer could test as early as six days before the day of their missed period or five days before the day of their expected period; they defined the day after a woman's expected period as the day of their missed period. They said they used both statements to enable the consumer to test by whichever method they were more comfortable with.  

C&D said they were not aware that market practice in the UK was for pregnancy test kits to refer to "the day the period was due" rather than "the day of the missed period".  They understood that manufacturers described the effectiveness of the product by measuring the day of either the "missed" or "expected" period and referred to both of those days because women chose to test for pregnancy either on their expected day of menses or the first missed day of menses.

C&D said they would be willing to amend the ad if it was found in breach of the CAP (Broadcast) TV Advertising Standards Code.

Clearcast said they approved the ad after reviewing compelling scientific evidence. They said the ad used two ways of communicating that consumers could receive early notification of being pregnant, because some women would want to test themselves on the day of their period and others the expected day after they had missed their period.

Assessment
Upheld
The ASA acknowledged that a notified body had awarded the product a CE mark and passed the claims on the packaging as conforming to the relevant Directive; we considered, however, that that did not mean the advertising claims were automatically acceptable. We considered that the difference between the day the period was due and the day of the missed period would not be immediately clear to viewers; viewers could understand that, if their period was due on a certain day and it did not come, that would be the day of the missed period. We considered therefore that they could interpret the claim "... it's possible to find out six days earlier than your missed period" to mean that the product could tell them if they were pregnant six days before the date their period was due. Because that was not the case, we considered that the ad was misleading. We noted the text at the bottom of the screen but considered that that was contradictory and was likely to further confuse, rather than clarify, the meaning for the viewer.

We welcomed C&D's offer to amend the ad.

The ad breached CAP (Broadcast) TV Advertising Standards Code rules 5.1 (Misleading advertising), 5.2.1 (Evidence) and 5.2.2 (Implications) and 5.4.6 (Comparative advertising).

Action
The ad must not be broadcast again in its current form.

Adjudication of the ASA Council (Broadcast)