Potters Ltd t/a Equazen 1 Botanic Court Martland Park Wigan WN5 0JZ Number of complaints: 2

Date: 12 December 2007 Media: National press, Leaflet Sector: Health and beauty

Ad
A national press ad and leaflet for eye q™ products:

a.  The national press ad stated "Naturally-sourced Omega-3 & Omega-6 oils  A Hi-EPA fish oil formula that may help maintain concentration levels and healthy brain development.  Will you choose the 'Clever Capsule' for your child?  Scientifically tested in schools*  Independently tested*  Naturally-sourced omega-3 & omega-6  No aspartame  No hydrogenated fats  No artificial colours". Text in a stamp in the top left-hand corner of the ad stated "NEW TRIAL PUBLISHED**".  The asterisks linked to small print that stated "*The Oxford-Durham Schools' Trial, Peterlee Sure Start Study, The Greenfield Study, The Eaton Hall Special School Study, The Sussex Research Project.  **'The Adelaide Trial' Sinn, N. & Bryan, J. (2007) Journal of Developmental & Behavioral Pediatrics, 28(2), 82-91 ...".

b.  The leaflet was headed "The original Omega 3 fish oil proven in schools".  Further text stated "The original hi-EPA Omega 3 and Omega 6 oils.  A unique fish oil formula that may help maintain concentration levels and healthy brain development ...".  Text inside the leaflet continued "Proven by Science ... The eye q™ formula has been independently tested by Education Authorities and researchers at leading universities, and the results have been published in leading scientific journals.  Many health and education professionals advise taking eye q™ as a trusted omega oils formulation.  More than one thousand children have taken part in independent trials using eye q™.  Children from the trials have shown significant improvements in concentration, reading and writing.  Children from the trials have become less excitable, less hyperactive and are less likely to be disruptive.  88% of customers said they believed that the formulation used in the trials had been of benefit (in an assessment of 2,732 respondents) ... eye q™ is naturally high in EPA because research shows this particular omega 3 fatty acid plays an important role in maintaining and developing certain aspects of brain and eye function, specifically learning ability ... Testimonials from both parents and children have indicated real benefits in mood and concentration ...".  

Issue
1.  One complainant challenged whether the claim "A Hi-EPA fish oil formula that may help maintain concentration levels and healthy brain development" in ad (a) could be substantiated.

A second complainant challenged:

2.  whether the eye q™ formula had been independently tested, as claimed in ads (a) and (b), because he understood that trial initiatives involving eye q™ had been sponsored by Equazen, the manufacturer of eye q™ products, and were therefore not independent;

3. the validity of the research conducted in the trials referred to in ad (b), because he believed that children who took part had to cut out sugary food from their diet and undertake exercise, which, he argued, would make the effects of the fish oil impossible to determine; and   

4. whether the trials could support the implication in ad (b) that the concentration and learning of all children would improve following supplementation with eye q™, because he understood that most trials were conducted on children with special educational needs or who displayed signs of Attention Deficit Hyperactivity Disorder (ADHD).

The CAP Code:

50.1;3.1;7.1;50.20

Response
1.  Equazen said ad (a) included a pack shot of Equazen eye q™ capsules and pointed out that the pack copy, which contained the claim "A Hi-EPA fish oil formula that may help maintain concentration levels and healthy brain development", had been approved by the Health Food Manufacturers' Association (HFMA).  They said the claim was a standard omega-3 food supplement pack claim, which was used by several manufacturers of omega-3 products.  They submitted examples of other marketers' packaging and advertising, which showed that similar claims relating to children's concentration and brain development were used by them.  They also submitted a copy of the certificate given by the HFMA upon approval of the packaging.

Equazen explained that the UK population, and children in particular, did not have sufficient nutrient intake, including polyunsaturated fatty acids (PUFAs), which were usually present in oily fish.  They sent a summary of available evidence which, they said, supported the importance of an adequate supply of key omega-6 and omega-3 PUFAs for optimal cognitive development and for promoting and preserving brain function throughout life.  They added that there was also evidence to suggest a benefit from the use of omega-3 and omega-6 supplementation in the management of certain neurodevelopmental problems such as ADHD, dyslexia and developmental coordination disorder (DCD), also known as dyspraxia, where there could be an underlying PUFA deficiency or an abnormality of PUFA metabolism.

They sent information on the results of four trials, which had examined the use of PUFA supplementation in relation to healthy brain function.  One study by Fontani et al. (2005), showed that when 33 healthy subjects were supplemented with essential fatty acids (EFA), omega-3 series compounds, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of 2:1, the results indicated a positive influence on the mental functions of the group, with effects on reactivity, attention, cognitive analysis of stimuli and emotional responses.

A second trial, Richardson and Puri (2002), investigated the effect of PUFA supplementation on the cognitive and behavioural symptoms of subjects with specific learning difficulties who also showed signs of ADHD.  29 subjects, 15 of whom were randomly allocated to receive supplementation of both omega-6 and omega-3 fatty acids and 14 of whom were allocated a placebo, participated in the trial, which demonstrated that supplementation was superior to the placebo in normalising a range of ADHD-related symptoms in children with specific learning difficulties.  

A third trial, Richardson and Montgomery (2005), investigated the effect of supplementation of PUFA, in the form of Equazen eye q™, on children who suffered from DCD.  The trial incorporated 117 children aged from five to 12 years and showed that, although supplementation appeared to have no effect on motor skills, significant improvements in literacy and behaviour were noted.  It concluded that supplements of the type used in the trial could provide a safe, tolerable and effective solution for improving academic progress and cognitive/behavioural problems among children with DCD.  

The fourth trial, Sinn and Bryan (2007), examined the effect of supplementation of PUFAs, in the form of Equazen eye q™ and other micronutrients (vitamins and minerals), on learning and behavioural problems associated with ADHD. The trial involved 132 children aged seven to 12 years who were randomised to receive either a placebo, PUFA supplementation or PUFA supplementation plus micronutrients.  Although no additional treatment effects were found in the PUFA plus micronutrient group compared to the PUFA only group, it was shown that PUFA supplementation reduced the core symptoms of ADHD - hyperactivity, impulsivity and inattention - to mildly clinical levels.

Equazen said four other observational studies had been carried out using eye q: the Greenfield Study; the Sure Start study; Durham SAT; and Durham Year 11 Initiatives.

The Greenfield study was a non-controlled trial, which incorporated 20 children who exhibited problems with concentration, behaviour and, in some cases, aggression.  Clinical assessment demonstrated symptoms of fatty acid deficiency.  After supplementation for three months, the participants' ratings on the Connors' Teacher Rating Scales, which indicated behavioural problems according to ADHD criteria, reduced significantly. The children had calmed down and were more focussed in the classroom, and behavioural incidents had reduced dramatically.  

The Sure Start initiative gave fatty acid supplementation to children aged 18 months to three years who had been identified as having significant language delays and were from a socio-economically deprived area. Sixty-five children participated, by taking supplementation for five months, and 47 completed the trial.  The results were based on parents' rating of their children's behaviour and concentration and reported significant improvements in both areas.  Although the group's language development was substantially behind that expected for their chronological age at the start of the study, after five months the group taking supplements showed a reduced lag in language ability.  

The Durham SATs methodology involved 97 pupils aged from nine to 11 in County Durham primary schools.  The primary outcome measures were based on Key stage 2 SAT results and changes in teacher-rated, ADHD-related symptoms.  

The Durham Year 11 Initiative methodology involved 3030 year 11 pupils in 35 mainstream schools and two special schools in County Durham.  The primary outcomes were measured by GCSE results and comparisons between those who had and those who had not participated.  Secondary outcome measures were to be evaluated from qualitative data from pupils, parents and schools.

Equazen said none of the methods involved the reduction of sugar intake and extra exercise.  Although not all of the study results were yet available, Equazen submitted a regional news article, which reported better than expected SAT results for the children who participated in the Durham trials.

Equazen also pointed out that none of the trials reported adverse effects associated with the product.  They believed, in view of the body of evidence in support of PUFA supplementation, together with the use of conditional language, the claim "A Hi-EPA fish oil formula that may help maintain concentration levels and healthy brain development" had been substantiated and did not mislead.

2.  Equazen said their research programme encouraged rigorous scientific practices to investigate the specific roles of EFA.  They said two randomised double-blind placebo-controlled trials (RCT) had been published to date: the Oxford-Durham Study (previously referred to as Richardson and Montgomery (2005)) and the Adelaide Trial (previously referred to as Sinn and Bryan (2007)).  They explained that neither of those trials were sponsored by Equazen but they had supplied active and placebo capsules at the respective investigators' request.  

Equazen said they were also involved in a parallel tier of study, which they facilitated but for which they did not provide financial support.  They explained that eye q™ was used in children's support groups or schools, using standardised assessments and observational methods to test its effect in a health or educational setting.  They said those types of open study were conducted independently and proved useful in obtaining subjective reports and insight into the mechanism of fatty acid supplementation.  

They explained that in all of the studies of that type referred to in ad (a) - i.e. Peterlee Surestart Study, Greenfield Study, the Eaton Hall Special School Study and the Sussex Research Project - Equazen supplied eye q™ free of charge but provided no other financial support. They pointed out that those projects were not sponsored by Equazen and they had in no way sought to influence their outcome.

3.  Equazen said the trials referred to in ad (b) were the Oxford-Durham Study and the Adelaide Trial, both of which were RCTs, were published in peer-reviewed publications and did not involve any reduction in the participating children's intake of sugary food or increase in the amount of exercise they undertook.  They submitted both trials in full for the ASA's attention.

The Oxford-Durham Study was sub-titled "A Randomized, Controlled Trial of Dietary Supplementation With Fatty Acids in Children With Developmental Coordination Disorder" and incorporated 117 children aged between five and 12 years who were identified as having signs of DCD.  The study's report showed that the results were reliant on supplementation only -  the trial did not involve any other dietary deviation or additional exercise programme - and concluded that children with DCD-related symptoms gained improvements in literacy and behaviour following supplementation with fatty acids.  

The Adelaide Trial, sub-titled "Effect of Supplementation with Polyunsaturated Fatty Acids and Micronutrients on Learning and Behavior [sic] Problems Associated with Child ADHD", involved 132 Australian children aged from seven to 12 years.  The children, who were identified as having symptoms of ADHD according to the Conners Index (a system to help assess ADHD and evaluate problem behaviour in children and adolescents), participated in a randomized, placebo-controlled, double blind intervention over 30 weeks, taking PUFAs alone, PUFAs plus micronutrients or a placebo.  The PUFA supplement used throughout the course of the study was Equazen eye q™.  It concluded that ADHD-related problems with inattention, hyperactivity and impulsivity might respond to treatment with PUFAs.  

The trial did not involve a biochemical analysis, so it was not possible to determine whether the children had nutritional deficiencies, but apart from the supplements supplied no other alteration in diet or activity levels was specified.

4.  Equazen said the claim "... may help maintain concentration levels and healthy brain development ..." was supported by those who purchased eye q™ and responded to an in-pack survey, which showed that 88% reported a benefit from taking the supplement.  They argued that this was a statistically robust UK consumer survey result and supported their belief that children's concentration and brain development could improve following supplementation with Equazen eye q™.

They added that scientific evidence, for example, Fontani et al (2005), supported the theory that there were cognitive benefits to be had from omega-3 supplementation in healthy subjects.

Assessment
1.  Upheld
The ASA noted packaging for eye q™ had been approved by the HFMA.  We understood that HFMA approval confirmed that the product's packaging met with all regulatory requirements, such as Food Labelling and Food Supplements Regulations, but also noted it did not indicate approval of any claims used on the pack, or endorsement of the product.  We acknowledged the packaging and ads Equazen submitted from other omega-3 product manufacturers incorporated similar claims.  We considered, however, that those were not appropriate evidence to support their own claim.

We noted Equazen had referred to the role of PUFAs in cognitive development; they had also pointed to scientific testing that had demonstrated the part PUFAs played in the correction of symptoms associated with ADHD and DCD.  We also noted their reference to studies that discussed the relationship between PUFAs and the normal growth and development of children, as well as their psychosocial and mental functioning, and the brain health of adults.  

We considered, however, that the claim "A Hi-EPA fish oil formula that may help maintain concentration levels and healthy brain development", in conjunction with the claims "the 'Clever Capsule'" and "Scientifically tested in schools", implied it had been scientifically proven that the product could have a positive effect on concentration levels and healthy brain development in a general population of all ages (we noted text in the ad stated "5 years to adult").        

We noted the four trials submitted by Equazen in support of the claim: Fontani et al (2005), Richardson and Puri (2002), Richardson and Montgomery (2005) and Sinn and Bryan (2007).  We understood that two of those four trials used Equazen's eye q product as the PUFA supplement in the testing and also recognised that the results showed a positive outcome in relation to the cognition, behaviour and reactivity of those who participated in the trials.  We noted, however, that three of the trials engaged with children who had been identified as having symptoms of ADHD or DCD and considered that those trials were unsuitable for use in support of a claim that was likely to be seen as referring to a general population.  

The fourth of those trials, Fontani et al (2005), examined the effects of PUFA supplementation on healthy subjects.  While we acknowledged that the trial reported improvements in the attention span and physiological functions of the participants, we noted the dosage used in the trial was not comparable with the daily recommended dosage of eye q™.  In the trial, a capsular supplement containing 200 mg EPA and 100 mg DHA was used over a period of five weeks, with participants required to ingest eight capsules per day.  We understood that Equazen recommended a daily intake of six capsules per day for 12 weeks followed by a daily intake of two capsules per day; eye q™ contained a compound of omega-3 fish oils together with omega-6 in the form of Evening Primrose oil and Natural Vitamin E.  Each capsule contained 83 mg EPA and 29 mg DHA.

Because the trial used a supplement with a different composition to Equazen's eye q™ and because the recommended dosage of the two supplements was not comparable, we considered that we had not seen evidence to show that the results of the trial were likely to be achieved from supplementation with eye q™.

In addition, we noted the trial included only 49 participants.  In the absence of further robust testing involving healthy subjects, we considered that that number was too low on which to base a claim for the general population.

We considered the further observational studies Equazen submitted: the Greenfield Study, the Sure Start Study, Durham SAT and Durham Year 11 Initiatives.  We understood that, while they indicated promising results, they were not randomised, controlled studies. It was therefore not possible to deduce whether the outcome results were based solely on eye q™ supplementation or any other factor.  Their findings, therefore, could not definitely support claims made in relation to children's concentration and learning.  In addition, we noted The Greenfield Study and the Sure Start Initiative were conducted on children who exhibited signs of behavioural problems or language development concerns and considered that the findings of those studies were not suitable for use in support of claims aimed at a general population.   

On this point, ad (a) breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness), 50.1 (Health & beauty products and therapies - General) and 50.20 (Health & beauty products and therapies - Vitamins, minerals and other food supplements).

2.  Not upheld
We noted Equazen had supplied the test material for use in the trials referred to in both ads but understood that they had had no further involvement in the trials. They had not initiated the tests or supplied financial backing in any other context.   

We considered that the ads' references to independent testing and trials implied eye q had been tested but Equazen had not initiated the tests or paid for them.  Because we understood that that was the case, we considered that the claim "independent" in relation to those trials was unlikely to mislead.

On this point, we investigated the ads under CAP Code clause 7.1 (Truthfulness) but did not find them in breach.

3.  Not upheld
We noted the complainant's concern that any benefit to be realised from omega-3 or omega-6 supplementation could not be detected if the trial participants simultaneously had to change their diet and undertake exercise.  We also noted Equazen's comment that the trials referred to in ad (b) were the Oxford-Durham and Adelaide studies and acknowledged that no other supplementation and no exercise was employed in either of those trials.

We noted the number of children involved in the Oxford-Durham and Adelaide studies was 117 and 132 respectively.  We also noted ad (b) stated "More than one thousand children have taken part in independent trials using eye q™".

Equazen had referred to further observational studies: the Greenfield Study, the Sure Start study and two Durham initiatives: SATs and Year 11.  We understood that those studies involved over 3,000 participants.  We also understood that the observational studies had not involved dietary or other lifestyle changes such as increased exercise.  

Although we considered that, for the reasons outlined in point 1, the results of neither the controlled nor the observational studies could substantiate claims about a benefit in the concentration and learning of a general population of either children or adults, we noted none of the studies had involved any changes to dietary or exercise behaviour.  

We concluded that, while the research was invalid for supporting the claims made for the product, it was not invalidated by lifestyle changes because the participants had not  cut out sugary food from their diet and undertaken exercise when taking part in the research.  

On this point, we investigated ad (b) under CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness), 50.1 (Health & beauty products and therapies - General) and 50.20 (Health & beauty products and therapies - Vitamins, minerals and other food supplements) but did not find it in breach.

4.  Upheld
We considered that the claim, "... may help maintain concentration levels and healthy brain development ..." although conditional, in conjunction with the claims "proven in schools" and "Proven by Science" and the references to trials, implied it had been scientifically proven that the product could have a positive effect on concentration levels and healthy brain development in a general population of all ages (we noted text in the ad stated "5 years to adult").  

We noted ad (b) made specific reference to the fact that eye q™ capsules were "used in the Durham Schools trial", which we understood was carried out on children who showed signs of having ADHD.  We considered, therefore, that that study was not suitable for substantiating a claim that was likely to be seen as referring to a general population of both children and adults.

We also understood that Equazen had conducted a general customer survey and reported a positive response rate, relating to the benefit from taking the supplement, of 88%.  

We acknowledged that the customer survey had indicated that the majority of respondents had reported a benefit and understood that Equazen believed the survey results to be sufficiently robust to support the ad's claims.  We considered, however, that that type of information, while providing a useful indicator, was not scientific evidence and was therefore not robust enough to substantiate the claims.  

We also acknowledged the trial Equazen brought to our attention in their response: Fontani et al (2005).  Although we understood that the trial conducted by Fontani et al had used 'healthy' participants, we noted the supplement used in that trial was not eye q and had a different composition to eye q.  We considered, therefore, that that trial was not satisfactory evidence for use in support of a product-specific claim.  

We concluded that we had not seen evidence to substantiate the implication in ad (b) that the concentration and learning of a general population of children or adults could improve following supplementation with eye q™.

On this point, ad (b) breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness), 50.1 (Health & beauty products and therapies - General) and 50.20 (Health & beauty products and therapies - Vitamins, minerals and other food supplements).

Action
We told Equazen to remove the claims "... may help maintain concentration levels and healthy brain development", "the Clever Capsule"Scientifically tested in schools", "proven in schools" and "proven by Science" from future advertising for eye q.  We also told them to avoid implying in future that the advertised product could benefit the general population or that a trials results related to a product with exactly the same composition and dosage as the advertised product if that was not the case.


Adjudication of the ASA Council (Non-broadcast)