Ad description

A website for sports accessories, www.fireflyrecovery.com, included text on the home page which stated "FIREFLY. Recover 2 times faster, reduce DOMS [delayed onset of muscle soreness] within 24 hours and improve sports performance with firefly". Text on a tab entitled "What is the Firefly?" and included the claim "REDUCES DOMS WITHIN 24 HOURS (CLINICALLY PROVEN)".

Issue

The complainant challenged whether the claims to 'reduce DOMS' were misleading and could be substantiated.

Response

Firstkind Ltd t/a Firefly explained that Delayed Onset Muscle Soreness (DOMS) occurred following high intensity exercise and that it typically began 12 to 14 hours after exercise and could be painful for up to 72 hours. They believed that active recovery (such as using the Firefly product) could aid in reducing the effect.

They provided a selection of clinical trials to demonstrate the existence of DOMS along with trials on the Firefly device, which they believed substantiated the claim for the reduction of DOMS. They also provided a study on a similar device which was not the Firefly.

Assessment

THIS ADJUDICATION REPLACES THAT PUBLISHED ON 1 OCTOBER 2014. THE VERDICT HAS CHANGED, MAKING THE COMPLAINT NOT UPHELD.

Not upheld

The ASA considered that consumers would not expect the claims “Reduce DOMS” to mean that the device would completely remove or prevent DOMS (delayed-onset muscle soreness). However, we considered that it would be understood to mean that using the product would result in a significantly noticeable reduction in DOMS.

We took expert advice on the submitted evidence. We noted that two of the papers which examined the efficacy of the Firefly device following exercise had been submitted for review. However, these were unpublished and without peer review at the time at which the ad was seen by the complainant. This was the period during which the relevant evidence needed to be available. However, we considered that this alone was not the basis upon which to reject the trials, providing they were sound and were capable of substantiating efficacy claims in the ad in such a way that the results could be shown to be statistically significant and that they formed part of a robust body of evidence.

We considered that the data could be summarised as showing that lower limb blood supply was increased by electrical stimulation and that it is well established that contraction of the calf and foot muscles (whether achieved electronically or voluntarily) affects blood flow.

We understood that each of the trials that used the Firefly device (under various names) was tested on healthy subjects and that some of the studies specifically examined men who were regularly involved in heavy contact sport (e.g. football and rugby). One of the trials examined Neuromuscular Electrical Stimulation (NMES) treatment of delayed-onset muscle soreness and reported a reduction of DOMS using electrical stimulation. We noted that the evidence demonstrated that the product reduced DOMS twice as quickly as without (the device) when worn for 12 hours, and we considered that such a reduction was likely to be significant.

Another trial, which specifically examined NMES on rugby and football players, compared players using the device following exercise against those who wore no device (the control group). This trial showed a measureable decrease in muscle soreness at 24 hours which we considered to be equivalent to a decrease in DOMS (at 24 hours) and we considered that consumers would find that significant.

Therefore, we considered that the trial evidence demonstrated a significant reduction and therefore concluded that the claim “Reduce DOMS” had been substantiated and was not misleading.

We considered the ad under CAP Code rules  3.1 3.1 Marketing communications must not materially mislead or be likely to do so.  (Misleading advertising),  3.7 3.7 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.  (Substantiation), 3.9 (Qualification),  3.1 3.1 Marketing communications must not materially mislead or be likely to do so.   (Exaggeration) and  12.1 12.1 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, and did not find it in breach.

Action

No further action required.

CAP Code (Edition 12)

12.1     3.1     3.7    


More on