ASA Adjudication on Equine America (UK) Ltd

Ad

Two ads, for a horse supplement, in equine magazines:

Ad (a) stated "The following equine joint supplements have no objective clinical evidence of improving joint mobility - NAF Five Star Superflex, EquiFlex, PREMIERflex HA, ExtraFlex HA, STRIDE HA, My Joints, Arthri Aid and NEW MARKET JOINT SUPPLEMENT. Cortaflex was successfully subjected to a double blind study of joint mobility at Michigan State University, Medicine Research Department. The rigorous study was led by world renowned clinician Dr Hilary Clayton BVMS, PhD, MRCVS. Force plates and six-camera Expert Vision Real Time were used to ensure that the findings were of the highest accuracy. The outstanding results of the study can be seen on the independent web site - www.jointsupplementresearch.com".

Ad (b) stated “The following Chondroitin / Glucosamine equine joint supplements have no objective clinical evidence of improving joint mobility - NAF Five Star Superflex, EquiFlex, PREMIERflex HA, ExtraFlex HA, STRIDE HA, My Joints, Arthri Aid and NEW MARKET JOINT SUPPLEMENT. Cortaflex was successfully subjected to a double blind study of joint mobility at Michigan State University, Medicine Research Department. The rigorous study was led by world renowned clinician Dr Hilary Clayton BVMS, PhD, MRCVS. Force plates and six-camera Expert Vision Real Time were used to ensure that the findings were of the highest accuracy. The outstanding results of the study can be seen on the independent web site - www.jointsupplementresearch.com".

Issue

VetVits Ltd challenged whether the claims:

1. that their product, EquiFlex, did not have any objective clinical evidence of improving joint mobility were misleading and could be substantiated;

2. denigrated VetVits Ltd.

3. RAP challenged whether the claims that Equine America (UK) Ltd (Equine America) had clinical studies for Cortaflex were misleading, because they understood that the trials had been conducted on a formulation of Cortaflex that was not available in the UK.

4. The ASA challenged whether the ads misleadingly implied that Equine America had robust objective clinical evidence that Cortaflex improved joint mobility.

CAP Code (Edition 12)

Response

1. Equine America stated that Equiflex had been the subject of a trial published under the title A Clinical Trial of an equine nutritional supplement containing glucosamine hydrochloride, chondroitin sulphate and manganese ascorbate on Equine Mobility. They said that the paper stated "the overall situation for each equine was achieved through the summation of the subjective assessment scores of four movement criteria". They said, from that statement, it was clear that VetVits Ltd did not have any objective clinical evidence of improving joint mobility and therefore the statement in the ads was not misleading.

2. Equine America said that the ads were solely making a statement of admitted fact. They also stated that they did not think the ads were either misleading or denigratory towards the other products listed. They considered that if a performance study had been undertaken on any of the products listed, it would have been made public either as a published ad or on the product websites. They said that they had conducted a careful review of those mediums for each product and, as there were no mentions of objective studies, they assumed that no such studies had been undertaken. They added that they had not received any information to the contrary from the other product manufacturers or distributors.

3. Equine America said that the clinical study referred to in the ads was conducted by Dr Clayton in summer 2002, on Equine Corta-Flx Solution, which was the version of their product sold in the US at the time. They said that the formulation of the product sold in the UK and Europe at that time was Equine Cortaflex Solution, which included all the same active ingredients. The two formulations did, however, have one differing ingredient, which was a preservative. The preservative used in the US formulation of the product, sodium benzoate, was not permitted for use in animal products in Europe and so this was substituted with ammonium proprionate.

Equine America also said that, since 2002, two additional active ingredients had been added to Cortaflex: sodium hyaluronate (also known as hyaluronic acid or hyaluronan) and avocado/soybean unsaponifiables, to further improve the products efficacy. Equine America gave the names of two published studies which they said had found that oral administration of the substances was beneficial to joint mobility.

4. Equine America said that Dr Claytons trial, which was detailed in the paper Double-Blind Study of the Effects of an Oral Supplement Intended to Support Joint Health in Horses with Tarsal Degenerative Joint Disease, was their objective clinical evidence that Cortaflex produced a more symmetrical gait pattern, which was interpreted as being indicative of an improvement in locomotor function. They said the claim that Cortaflex improved joint mobility was a fair and reasonable presentation of that conclusion. They submitted a copy of the paper, which was published in the Proceedings of the American Association of Equine Practitioners (AAEP) in 2002. They added that the representation of the study at www.jointsupplementresearch.com was less specific on a number of points than the original paper, and that it was not the evidence base on which they relied.

Assessment

1. Not upheld

The ASA noted that in a recent adjudication on a complaint that VetVits claim that the efficacy of their product Equiflex was "clinically proven" to benefit the joint health of horses, we had found that the trial on which the claim was based was not sufficient to substantiate the claim. We therefore concluded that the claim in the ads that Equiflex had "no objective clinical evidence of improving joint mobility" was accurate and was not misleading in relation to the competitors product.

On this point, we investigated the ads under CAP Code (Edition 12) rules 3.1 (Misleading advertising) and 3.33 (Comparisons with Identifiable Competitors), but did not find them in breach.

2. Upheld

We acknowledged that the ads accurately claimed that VetVits did not have objective clinical evidence that Equiflex improved joint mobility, and that therefore the claim was factually accurate. However, we considered the ads went beyond that, because they implied that Equiflex was an inferior product compared to Cortaflex, on the basis that Cortaflex did have objective clinical evidence of its efficacy. We considered the evidence Equine America submitted in support of the claim that Cortaflex improved joint mobility, under Point 4 below. Because Equine America also did not have objective clinical evidence that their product improved joint mobility and was therefore superior in that respect, we concluded that the ads unfairly discredited Equiflex and denigrated VetVits.

On this point, the ads breached CAP Code (Edition 12) rule 3.42 (Imitation and Denigration).

3. Upheld

We understood that at the time of Dr Claytons study in 2002, the US and European formulations of the product shared the same active ingredients but, to comply with European regulations, the products contained different preservatives. We considered that, because the active ingredients were the same, the findings of the study were at that time applicable to the European formulation of the product.

Nonetheless, we noted that, since 2002, two additional active ingredients had been added to the product. We noted that Equine America believed that the two studies in relation to those substances demonstrated that they would improve the efficacy of their product, but because we had not seen the studies we were unable to assess their findings. Furthermore, we understood from the titles of the studies that they examined the effects of those two substances in isolation, rather than in combination with the other active ingredients found in Cortaflex.

Because we understood that Equine America had not conducted any clinical studies on the formulation of Cortaflex currently available in the UK, we concluded that the ads were misleading.

On this point, the ads breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).

4. Upheld

We considered that the ads implied that the clinical paper at www.jointsupplementresearch.com constituted the "objective clinical evidence" that Cortaflex "improve[d] joint mobility". However, we noted that Equine America had stated that that clinical paper was not the evidence on which they had based their claim. We therefore considered that the ads were misleading in that regard.

We noted that the evidence on which Equine America had based the claim had previously been considered by the ASA in a complaint about their advertising in 2004, in which case we had taken expert advice. We referred back to the experts report, which reviewed both the clinical paper at www.jointsupplementresearch.com, and the paper published in the Proceedings of the AAEP. Both papers referred to the same clinical study by Dr Clayton, which was conducted on eight horses, using the formulation of Cortaflex sold in the US in 2002.

We noted that the expert raised significant concerns about the study design, including concerns over the varied nature of the horses lameness, the method by which it was assessed, and that it was unclear whether the horses had been kept in a controlled environment throughout the study. The expert also raised significant concerns about the robustness of the statistical analysis of the data, particularly because the study group consisted of only eight horses, the duration of the study was only two weeks, and there was a disparity between the data published in the Proceedings of the AAEP and the clinical paper on the website. The expert also said that although the AAEP was a highly respected organisation of veterinary surgeons, the paper related to conference proceedings rather than being a peer-reviewed scientific journal.

We considered that the trial on which both papers were based was not sufficient to substantiate the claim that Equine America had "objective clinical evidence" of Cortaflexs efficacy, in either its 2002 or current formulation. We therefore concluded that the ads were misleading.

On this point, the ads breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).

Action

The ads must not appear again in their current form. We told Equine America to ensure they held robust substantiation for future claims. We also told them to ensure they did not discredit or denigrate other products or marketers in future.

Adjudication of the ASA Council (Non-broadcast)