Claims for the Aviform horse joint supplement Suppleaze Gold, seen on 12 May 2016 on the advertiser’s own website and in Horse & Hound magazine:
a. The advertiser’s website www.aviform.co.uk included the claims “Suppleaze Gold … includes the optimum ratios of Glucosamine HCL (5.5g) and Chondroitin (2g) per 10g of product … Proven. Published scientific research has shown that nutritional supplements containing Glucosamine HCL and/or Chondroitin Sulphate (at the correct levels) has [sic] a significant part to play in equine joint health. Recent research conducted by Raquel Baccarin, DVM, PhD, professor of veterinary medicine at the University of Sao Paulo, revealed significant improvement in flexion tests, decrease in joint volume and improved radiographic scores on horses supplemented with Glucosamine and Chondroitin (at the correct ratio). This study was conducted on 47 athletic horses, 20 healthy and 27 with osteoarthritis … Optimum ratio of ingredients based on latest research”.
b. The ad in Horse & Hound magazine included the claims “Suppleaze Gold … includes the optimum ratios of Glucosamine HCL (5.5g) and Chondroitin (2g) per 10g … Proven. Published scientific research has shown that nutritional supplements containing Glucosamine HCL and/or Chondroitin (at the correct levels) has [sic] a significant part to play in equine joint health”.
The complainant, a registered horse riding instructor, who believed the ads implied that the product would improve equine joint health due to its glucosamine HCL and chondroitin content, challenged whether the claims were misleading and could be substantiated.
Aviform said they would remove the references to the clinical study from the advertising, as well as references to the product containing the “optimum ratios” of those substances. However, they were not prepared to make further changes to their advertising.
In support of the advertising claims they provided copies of two studies. One, published in 2006, examined the effects of a competitor’s glucosamine and chondroitin supplement on horses aged between 15 and 35 years, over a three-month period. Aviform said the study found the supplement improved joint motion in horses.
A second study, published in 2009 in a peer-reviewed journal, examined the effects of a different competitor’s glucosamine and chondroitin supplement on horses with moderately severe osteoarthritis over a period of five months. Aviform highlighted that the supplement used in this study contained slightly lower levels of glucosamine and chondroitin than Suppleaze Gold (0.1 g and 0.2 g less, respectively). The study concluded that daily administration of glucosamine plus chondroitin provided a significant reduction in arthritic pain. Aviform also provided a copy of a document which summarised a number of trials conducted using the same competitor’s glucosamine and chondroitin supplement.
Both ads included the claim “Published scientific research has shown that nutritional supplements containing Glucosamine HCL and/or Chondroitin (at the correct levels) has [sic] a significant part to play in equine joint health”; claims that the product had the “optimum ratios” of those substances; and a claim that the combination of ingredients would “support your horse’s mobility for maximum benefit”. The ads also featured additional claims such as “Ultimate Joint Care” and “Nourishes, conditions, replenishes and lubricates the cartilage in joints”. The ASA considered consumers would understand from the ads that the product would improve equine joint health in healthy horses due to the glucosamine HCL and chondroitin it contained. We expected Aviform to provide documentary evidence, in the form of studies on horses, to support such claims.
Both ads referred to a trial of glucosamine and chondroitin supplementation in horses as evidence of the efficacy of Suppleaze Gold. Aviform did not, however, provide a copy of that study to the ASA for our assessment. While we had not seen the study in question, we considered that in order for such a study to be sufficiently adequate to support the claims of efficacy featured in the ads, it would need to be methodologically robust; have found statistically significant positive results for the efficacy of the supplement; and have used a similar supplement as that being advertised (for example, the supplement used in the trial should, like Suppleaze Gold, be administered orally, and should not administer higher levels of glucosamine and chondroitin than were contained in Suppleaze Gold).
The 2006 study was a small-scale study involving a placebo group of five horses and a treatment group of 15 horses that were given a supplement containing 2 g of purified chondroitin sulphate, 5 g of glucosamine hydrochloride and 0.5 g of N-acetyl-D-glucosamine per 10 g. The study was double-blinded, with the placebo group given a supplement that looked the same as that given to the treatment group.
The horses were selected on the basis of age criteria only (all were aged between 15 and 35 years) rather than on medical or athletic history and randomly allocated into the two groups. The primary outcome measure was whether there was a change in the range of joint motion, with secondary outcome measures being whether there were changes in trot stride length, swing length and stance duration. Skin markers were applied to anatomical points on each horse, to enable measurement of the range of motion of six joints (three joints in the forelimb and three in the hindlimb) through computer modelling of video footage of the horses trotting past a fixed point. Measurements were taken immediately prior to treatment and then at weeks 4, 8 and 12. Average results at each measurement point were calculated for each group and subjected to statistical analysis.
No statistically significant results were found at week 4. At weeks 8 and 12, the range of motion in three joints (one in the forelimb, two in the hindlimb) had improved significantly, as had trot stride length. Swing duration in both fore- and hindlimbs had improved significantly at week 12 but no significant improvements were seen in stance duration.
We noted that the study was double-blinded and randomised, and that objective criteria were used to measure the outcomes. However, we were concerned that no medical assessment of the horses had been carried out prior to their inclusion in the study and as a result it was possible that at baseline there may have been some significant differences between the medical statuses of the two groups, including the possibility that some may have had degenerative joint diseases. It was therefore not clear whether the results of the trial could be extrapolated to healthy horses such as those that Suppleaze Gold was intended for.
No information was provided about how the randomisation process was carried out, or the final age make-up of the two groups. We considered the absence of information about the age ranges in each group, along with the absence of information about the medical status of the horses, meant that the study had not taken account of how these differences could have affected the outcomes. We considered that was particularly significant given that it was a small-scale study, and there was a large difference in the number of horses included in the placebo group compared to the treatment group; that meant that the status of individual horses could have had disproportionate impacts on the results. Additionally, we noted that significant improvements had only been observed in three of the six joints assessed. Also, because the results were only presented as pooled assessments of each of the three forelimb joints and three hindlimb joints in each group, it was not clear whether or not any horses saw significant improvements in more than one joint. We concluded that overall the study was not sufficiently robust to substantiate the claims of efficacy in the advertising.
The 2009 study Aviform provided involved five groups of either five or six horses with moderately severe osteoarthritis: a placebo group; three groups which were given different amounts of undenatured type II collagen (UC-II); and a group which was given a glucosamine and chondroitin supplement manufactured by one of Aviform’s competitors. That supplement contained 5.4 g of glucosamine and 1.8 g of chondroitin per 10 g. This group of horses were given two supplements per day for the first month, followed by one supplement per day for the remaining four months of the trial. Following statistical analysis of the results, the study concluded that taking the supplement twice daily for a month, and then once daily for a further four months, significantly reduced arthritic pain by 60 days of treatment, and that maximal pain reduction was observed after 150 days.
We noted that Suppleaze Gold contained slightly higher levels of glucosamine and chondroitin than the supplement used in the trial, and we understood that Aviform recommended that, for mid-size horses, 20 g of Suppleaze Gold should be given daily for the first month, and thereafter either 5 g daily for “Maintenance”, 10 g daily for “Elevated Maintenance” or 20 g daily for “Challenged Joints”.
We noted the study was conducted on horses suffering from moderately severe osteoarthritis, whereas the supplement Suppleaze Gold was intended for healthy horses. We understood that horses with osteoarthritis might have a different response to the supplement than healthy horses. We therefore considered it was not appropriate to extrapolate the results of the study to the healthy horses such as those that Suppleaze Gold was intended for.
Additionally, we understood that the trial’s key outcome measures of overall pain, pain upon limb manipulation and physical examination were all evaluated via a ten-point or four-point grading system (depending on the measure) in which, following observation by examiners, each horse was assigned a grade at baseline and then monthly until the end of the trial. We were concerned that the grading systems were based on subjective observation of the horses rather than on objective data (in contrast to the 2006 trial in which footage of the horses was analysed using computer modelling).
We further considered that when using a subjective method of measurement such as observation of a horse’s gait, it was essential for the examiners to be blinded as to into which group each horse was allocated to ensure that there was no unconscious bias when evaluating the horse’s joint health throughout the trial. However, the study did not state whether the examiners in the study were blinded as into which group the horses were assigned, nor did it state whether horses had been randomly allocated to the groups, which would have ensured that the initial conditions of the horses would not lead to bias in the outcomes. We were therefore concerned that the trial was not double-blinded or randomised. Because the study was not randomised, evaluation of the horses was conducted solely through subjective measures, and the examiners evaluating the horses were not blinded, we considered the study design was not sufficiently methodologically robust for the results to be used to support the claims of efficacy in the ad.
With regard to the document which summarised further trials conducted on that competitor’s supplement, we noted that only very brief summaries of the findings had been included. We considered there was not sufficient information for us to conduct a full review of the findings or the methodologies of those studies and we therefore considered that the document did not constitute sufficiently robust evidence to support the claims of efficacy in the ad.
Because we had not seen evidence that was adequate to support the advertising claims that Suppleaze Gold would improve equine joint health in healthy horses due to its glucosamine HCL and chondroitin content, we concluded the claims had not been substantiated and were therefore misleading.
The ads breached CAP Code (Edition 12) rules
Marketing communications must not materially mislead or be likely to do so.
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.
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease. (Medicines, medical devices, health-related products and beauty products).
The ads must not appear again in their current form. We told Aviform Ltd to ensure that they held suitably robust evidence to support efficacy claims for their products.