Advertising Standards Authority
Adjudication on Mouthwear Technology Ltd

Mouthwear Technology Ltd t/a Performance Mouthwear UK

64 Cathedral Road
Cardiff
CF11 9LL

Date:

26 November 2014

Media:

Internet (on own site)

Sector:

Health and beauty

Number of complaints:

1

Complaint Ref:

A13-245751

Background

Summary of Council decision:

Five issues were investigated, all of which were Upheld.

Ad

A website for Performance Mouthwear UK, www.performancemouthwearuk.co.uk, included a web page headed "HOW IT WORKS". Further text stated "UNCLENCH YOUR JAW & UNLEASH A BETTER ATHLETE How Armour Bite works … When you train and compete, your natural reaction is to clench your jaw. It's part of the ‘fight or flight’ wiring of your brain. Your clenched jaw and teeth compress your temporomandibular joint (TMJ), triggering your brain to release an excess amount of performance-sapping hormones (like cortisol) that produce stress, fatigue and distraction. UA Performance Mouthwear helps the human body help itself. ArmourBite Technology prevents your teeth from clenching and pivots your jaw forward to relieve pressure on the TMJ. Gone are the excess negative hormones and the energy-draining effects, so the body can now unleash its full potential. ARMOURBITE IS ENGINEERED TO HELP UNLOCK YOUR HIDDEN POWER AND POTENTIAL. ArmourBite, the technology developed by Bite Tech, is an entirely new category of sports equipment. Now, athletes in any sport - from football to golf to running - can capitalize on innovative technology that makes you stronger, faster and better. Whether you want to improve your game or you need added protection in contact sports, Under Armour Performance Mouthwear products give every athlete a competitive edge". Also, "NO ONE EVER TOLD YOU THAT YOUR JAW COULD HELP YOU PERFORM BETTER … WHAT IT DOES Increases Strength. With improved airflow and less stress from clenching, UA Performance Mouthwear has been proven to increase strength by an average of 17% with the UA Performance Mouthpiece and 12% with the UA Performance Mouthguard. Increases Endurance. UA Performance Mouthwear enlarges airway openings, resulting in 25% less lactic acid build-up after 30 minutes of intense exercise. Speeds Up Reaction Time. Athletes may respond faster when wearing UA Performance Mouthwear. Clinical trials show an improvement in responding to auditory cues and potential improvement in response to visual cues. Reduces Athletic Stress. Excess cortisol causes stress, fatigue and distraction. UA Performance Mouthwear decreases cortisol production, which means you feel & play better. Reduces Impact. When the jaw suffers an impact, energy can be transmitted to the head, which can cause concussion. UA Performance Mouthguards have been shown to reduce the G-Force impact of blows to the jaw by up to 20%".

Further text stated “ ONE TECHNOLOGY FOR EVERY ATHLETE” and “ArmourBite, the technology developed by BiteTech, helps your body help itself by unlocking the power of the jaw. Now you can unleash your full potential and perform better across all sports”. Further text below listed various sports under the headings “FULL CONTACT SPORTS”, “LIMITED CONTACT SPORTS” and “NON-CONTACT SPORTS”.

Issue

The complainant challenged whether the following claims could be substantiated:

1. “Increases Strength”;

2. “Increases Endurance”;

3. “Speeds Up Reaction Time”;

4. “Reduces Athletic Stress”; and

5. “Reduces Impact”.

CAP Code (Edition 12)

Response

1. - 5. Mouthwear Technology Ltd t/a Performance Mouthwear UK said that the products had been researched for several years prior to launch in the USA. They said that the products were launched to the dental profession where product efficacy and research-based evidence along with practical proof were a pre-requisite for acceptance. They said that over 5000 dentists globally were licensed providers of the products. They said that Bite Tech, who manufactured the products, were confident that the claims could be substantiated. They provided evidence which they said substantiated the claims, including: two studies; a compendium to a dental journal on the topic of mouthwear and athletic performance which included further studies; a number of abstracts of studies; further general information about the products; and testimonials.

They said that: the term “mouthwear” as used on their website referred to all of the products which they offered; the term “mouthguard” referred to a product worn on the upper teeth and designed for contact sports, some of which featured their wedge technology to improve performance; and the term “mouthpiece” referred to a product worn on the lower teeth and designed for limited or non-contact sports, featuring their wedge technology to improve performance.

Assessment

THIS ADJUDICATION REPLACES THAT PUBLISHED ON 26 MARCH 2014. THE WORDING HAS BEEN CHANGED BUT THE 'UPHELD' DECISIONS REMAIN THE SAME.

The webpage was headed “HOW IT WORKS” and the text referred to “mouthwear” in general. It also stated “ONE TECHNOLOGY FOR EVERY ATHLETE” and listed various contact and non-contact sports. In the context of the webpage we therefore considered that consumers were likely to understand that the claims “Increases Strength”, “Increases Endurance”, “Speeds Up Reaction Time” and “Reduces Athletic Stress” related to all of their mouthwear product offerings which used their wedge (“ArmourBite”) technology. We considered consumers would understand the claim “Reduces Impact” to relate to their mouthguard products with wedge technology, because it would not be of relevance in non-contact sports and because the text underneath referred to mouthguards only. The ASA sought expert advice on the evidence provided by Mouthwear Technology.

We understood that the studies involved the use of various Mouthwear technology mouthwear products. We considered that the evidence was therefore directly relevant to those products, and that it might indirectly be relevant to similar products in the range, although not with such a high degree of confidence. We were not aware of any robust substantive evidence in support of the general concept that jaw repositioning could improve whole body performance. We also noted that the majority of the exercise models used in the studies were of short duration (under 30 minutes) and were not sport specific, whereas the majority of the sports listed in the ad had a longer duration and would have a greater variety of exercise intensity than used in the studies.

1. Upheld

In relation to the claim "increases strength", we noted that text underneath the claim went on to state "UA Performance Mouthwear has been proven to increase strength by an average of 17% with the UA Performance Mouthpiece and 12% with the UA Performance Mouthguard". Mouthwear Technology provided an abstract of a 1999 Master's thesis in support of the claims. However, because we were not able to examine the data in full we did not consider that the abstract was sufficient evidence on which to base the claim. We also considered that in general a Master’s thesis was unlikely to be sufficient to support such a claim because it had not been subject to peer review. We noted that some of the testimonials which had been provided referred to various perceived improvements in performance. However, we did not consider that testimonials were sufficient evidence to support efficacy claims for the products. We therefore concluded that the evidence provided was not sufficiently robust to substantiate the claim that the products could increase strength.

On this point the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising) and 3.7 (Substantiation).

2. Upheld

In relation to the claim "increases endurance" we noted that text underneath the claim went on to state "UA Performance Mouthwear enlarges airway openings, resulting in 25% less lactic acid build-up after 30 minutes of intense exercise". We understood that ‘endurance capacity’ was the ability to maintain exercise output over an extended period at a fixed work output, whilst ‘endurance performance’ was the ability to complete an endurance event (usually of a period longer than one hour) as quickly as possible. Heart rate and rate of blood lactate accumulation reflected the intensity of exercise being undertaken, and were therefore not measures of endurance capacity or performance per se. However, if carefully and correctly interpreted within the framework of a defined standardised exercise test, they could provide an indication of an individual’s endurance capability. Mouthwear Technology provided three study abstracts and two full studies that were relevant to the claim.

The abstract of a 2009 study concluded that the use of a mouthpiece led to statistically significant reductions in lactate levels after exercise, compared to no mouthpiece. However, because we were not able to examine the data in full we did not consider that the abstract was sufficient evidence on which to base the claim. We also noted that the study related to a 30 minute period of high intensity exercise, and therefore would not generally be considered an ‘endurance’ task, although we noted that the ad referred to “30 minutes of intense exercise”. The abstract of a second 2009 study concluded that the use of a particular Bite Tech mouthpiece improved muscular endurance. However, because we were not able to examine the data in full we did not consider the abstract was sufficient evidence on which to base the claim. We also noted that the study was significantly confounded by the fact that all volunteers completed the ‘no mouthpiece’ condition on day one, followed by the ‘mouthpiece’ condition on day two.

A 2009 pilot study, which had been published in a peer reviewed sponsored journal supplement, examined the effects of mouthpiece use on lactate levels in ten male subjects aged from 18 to 21 years. The subjects completed two 30-minute runs on a treadmill, and lactate levels were assessed at 0, 15 and 30 minutes of the run. Participants were randomly assigned a Bite Tech mouthpiece during each running trial. The lactate levels from pre- to post-exercise were lower with the mouthpiece than without. However, the difference was not statistically significant. We also noted that as a fixed exercise bout, performance per se did not differ between the two study conditions, and the authors had not reported any functional changes that were likely to result in performance improvements. A 2011 study, which had been published in a peer reviewed journal, examined the effects of mouthpiece-use on gas exchange parameters during steady-state exercise in 16 male and female subjects aged from 18 to 21 years. The subjects completed two 10-minute runs on a treadmill for each of three conditions: mouthpiece; no mouthpiece; and nose breathing. The conditions were allocated randomly for each participant and session and the subjects were provided with custom-fitted Bite Tech mouthpieces. Results showed that voluntary oxygen consumption, voluntary oxygen consumption per kg of body mass and the amount of expired by-product of metabolism were all higher by a statistically significant amount when the mouthpiece was used, compared to no mouthpiece and nose breathing. However, this indicated that the subjects were working less efficiently when wearing the mouthpiece, because they required more oxygen, and therefore the study did not support a performance improvement with the mouthpiece. A further abstract appeared to be a sub-sample of the 2011 study.

We concluded that the body of evidence provided was not sufficiently robust to substantiate the claim that the products could increase endurance.

On this point the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising) and 3.7 (Substantiation).

3. Upheld

In relation to the claim "speed up reaction time" we noted that text underneath went on to state "Athletes may respond faster when wearing UA Performance Mouthwear. Clinical trials show an improvement in responding to auditory cues and potential improvement in response to visual cues". A 2009 study, which had been published in a peer reviewed sponsored journal supplement, examined the effects of a Bite Tech mouthpiece on auditory and visual reaction times. There were 34 subjects in the auditory arm of the study and 13 in the visual aged from 18 to 21 years. In the auditory arm of the study, mean reaction times were 8.5 milliseconds (ms) faster with the mouthpiece than without and the difference reported was statistically significant. However, only 60% of subjects were more successful with the mouthpiece. In the visual arm of the study the differences in reaction times depending on whether or not the mouthpiece was worn were not statistically significant. We also noted that the paper did not include a comprehensive description of the study, including the order of the presentation of the experimental conditions or whether this was randomised. It also did not report on how the data was treated and analysed. We also understood that the mean reaction time for humans was around 215 ms, which would vary depending on various factors and could be less than 200 ms for some sports people. The reaction times reported in the study (241 - 249 ms) appeared to be relatively slow, and therefore did not provide strong evidence of a performance improvement. We concluded that the evidence was not sufficiently robust to substantiate the claim that the products could improve reaction time.

On this point the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising) and 3.7 (Substantiation).

4. Upheld

In relation to the claim "reduces athletic stress" we noted that text underneath went on to state "Excess cortisol causes stress, fatigue and distraction. UA Performance Mouthwear decreases cortisol production, which means you feel & play better". Mouthwear Technology provided one full study and one abstract which were relevant to the claim. We understood that stress was a necessary part of physical exercise and sporting performance, and that it needed to be considered in terms of both psychological and physiological parameters. Specifically, systemic cortisol concentrations could change either as a direct response to exercise or as a result of an indirect effect of blood glucose utilisation.

A 2011 study, published in a peer reviewed journal, examined the effects of a Bite Tech mouthpiece on cortisol levels during an intense bout of resistance exercise. Twenty-eight football players aged from 18 to 22 years performed two bouts of intense resistance exercise for one hour, once wearing a mouthpiece and once without, with the order decided randomly. Cortisol levels in their saliva were measured pre-exercise and at 25, 45 and 60 minutes during exercise and 10 minutes post-exercise. There were no differences in salivary cortisol concentrations between conditions pre or during exercise, but salivary cortisol concentrations were night in the ‘no mouthpiece’ condition at 10 minutes post exercise. Two other abstracts from 2008 and 2009 had also studied salivary cortisol concentrations during exercise and had not found there to be differences between the mouthpiece and no-mouthpiece conditions. We understood that there was a debate about whether it was preferable to collect whole mouth or single gland saliva and the strengths and weaknesses, in terms of data interpretation, is something which should be considered by investigators. Furthermore, saliva cortisol concentrations only reflected the active component of the cortisol concentration measured in blood. This was advantageous when assessing association but could be limited when determining cause and effect relationships. We also noted the possibility that the wearing of a mouthpiece could interfere with normal salivary secretions, and that the difficulty in using a genuine placebo meant it was difficult to partition out the potential influence of this factor. We considered that the 2011 study suggested that there was possibly a reduction in salivary cortisol concentration during post-exercise recovery, but that it was unclear if this was a genuine physiological effect. We therefore concluded that the evidence provided was not sufficiently robust to substantiate the claim that the products could reduce athletic stress.

On this point the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising) and 3.7 (Substantiation).

5. Upheld

In relation to the claim "reduces impact" we noted that text underneath went on to state "When the jaw suffers an impact, energy can be transmitted to the head, which can cause concussion. UA Performance Mouthguards have been shown to reduce the G-Force impact of blows to the jaw by up to 20%". Mouthwear Technology said the claim "reduces impact" was simply a statement of the protective qualities of a mouthguard with a composite structure and they did not refer to any specific evidence. Whilst we understood that it was generally accepted that use of a mouthguard during contact sports could reduce the risk of injuries to the mouth and teeth, we had not seen evidence that use of the products could reduce the risk of concussion and reduce the impact of blows to the jaw by up to 20%. We therefore concluded that the claim "reduces impact" had not been substantiated.

On this point the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising) and 3.7 (Substantiation).

Action

The ad must not appear again in its current form. We told Performance Mouthwear UK to ensure they held sufficiently robust evidence when making efficacy claims for their products.

This page was posted on November 26, 2014.

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