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Product: Health & Beauty
Advertiser: FX Supplements
Medium: Online - Company Website
ASAI Code 7th Edition: 2.4(c), 4.1, 4.4, 4.9, 4.10, 4.15, 4.16, 4.17, 4.19, 11.1, 11.2, 11.3
A product listing for Lactigo stated:
“Go Further, Faster with the revolutionary first of its kind training aid that is transforming the athlete world. World records will be broken is how this product LactiGo is being described by leading world experts.
LactiGo extends your peak performance during exercise while simultaneously reducing soreness & fatigue. It is banned substance tested and informed sport approved. LactiGo is proven to increase performance in 45 mins of use from the first time you use it.
LactiGo with Carnosine is a skin hydration gel created specifically for athletes to be refreshing, lightweight, and easily absorbed for delivering lasting results. Clients have noted improvements in the following areas;
• Up to 15% increase in performance by elite athletes after one application (Journal of exercise physiology)
• Delivers a significant competitive edge
• Delayed time to fatigue
• Improved watt output
• Reduces levels of lactate build-up
• LactiGo users ran up to 9 seconds faster
• Reduces symptoms of DOMS
• Improved feelings of recovery reported post extended aerobic endurance and high intensity.”
The complainant raised the following issues:
The complainant challenged whether the claim “World records will be broken is how this product LactiGo is being described by leading world experts.” was misleading and could be substantiated, particularly as they noted that no source had been provided for the claim:
The complainant challenged whether the claim “LactiGo is proven to increase performance in 45 mins of use from the first time you use it.” could be substantiated and questioned where the claim originated:
The complainant challenged whether the claim “Up to 15% increase in performance by elite athletes after one application (Journal of exercise physiology).” had been substantiated by the referenced Journal as they considered that the claim was misleading:
The complainant questioned whether the claim “Reduces levels of lactate build up”
had been substantiated and asked how the levels had been measured and if a muscle biopsy had been carried out.
The complainant challenged whether the claim “LactiGo users ran up to 9 seconds faster.” could be substantiated and they requested evidence for the claim.
The advertisers said that the claims made were as a result of two studies, and after consultation with the contributor of one of the studies, Chad Macias, together with testimonials from Lactigo users. The advertisers provided a copy of the two studies in question:
1. Official Research Journal of the American Society of Exercise Physiologists ISSN 1097-9751 - Evaluation of the Efficacy of Lactigo™ Topical Gel as an Ergogenic Aid Tim Sharpe, Chad Macias. Human Nutrition and Functional Medicine, University of Western States, Portland, OR, USA. Department of Health Wellness and Recreation, University of San Diego, SanDiego, CA, USA.
2. Pilot Study – The effects of Lactigo Topical Gel on Blood Lactate and Performance Variables. Submitted by A.C. Fry, J. Nicoll, E. Mosier, C. Seasholtz, M. Tilden, H. Molden. Jayhawk Athletic Performance Laboratory.
The advertisers advised that Study 1 was a peer-reviewed study and that the Journal of Exercise Physiology only published peer-reviewed studies.
They stated that while Study 2 was not a peer-reviewed study, it had value as it had been done independently of the manufacturer or any of its affiliates, therefore it was unbiased data. They said that this study had showcased independently conducted data collection and hypothesis solely from the University that carried out the study and was the next best thing to peer-review and better than an internally generated white paper. They said that the data in the Pilot Study was very strong.
The advertisers said that the claim that “World records will be broken” was taken from a testimonial from an Olympic and world champion medallist American long jumper (name provided). The testimonial by the athlete stated:
“Using LactiGo has definitely increased my performance. I have been using LactiGo for three years maybe now and I've already, I've broken an American Record with it. I've had the top jumps in the world for the past three to four years because of using LactiGo, so I definitely can say it has helped me a lot."
They also referred to video testimonials by a US Champion Ultra Runner and an Everesting World Record holder and said that the manufacturer and its distributors held signed and dated testimonials for each athlete which were available if required.
They said that all three athletes’ testimonials related to the product on sale, which was the non-menthol formulation, and they considered the three published or independent studies supported the claims in the testimonials.
The advertisers said that the claim made was based on the results of study 1, Evaluation of the Efficacy of LactiGo Topical Gel as an Ergogenic Aid. They said that the rapid increase in skeletal muscle concentrations of Carnosine and subsequent improvement in performance was evidenced by Sharpe et al. (2016) in which participants saw a statistically significant increase in exercise performance during a1000m sprint 45 mins after initial application of LactiGo gel with no prior use. This was also evidenced by the observations of Dieter et al. (2021)*, an additional peer-reviewed study, in which researchers documented a rapid rise in skeletal muscle concentrations of carnosine 30 mins after initial application, which indicated that a bolus amount of Carnosine could be rapidly delivered to skeletal muscle.
*Study 3: Transdermal delivery of carnosine into equine skeletal muscle, B.P. Dieter, C.J. Macias, T.J. Sharpe, B. Roberts, M. Wille, A. Young, C Reisenauer, B. Cantrell and W.M. Bayly.
In response to the complaint, they said that the study that was published in the Journal of Exercise Physiology (Study 1), looked at the performance of elite Soccer players performing both aerobic and anaerobic exercise. The authors, Sharpe et al. (2016) documented large increases in performance in several tests, including an increase in performance in the intermittent yo-yo test of 14.79% by athlete B.G., an 11.36% improvement in the intermittent yo-yo test by athlete T.A. and a 10.15% increase in performance during a 1000m sprint by athlete B.S. They said that this was observed with no prior use history and after only one application of LactiGo gel.
The advertisers referred to Study 2, a pilot study which assessed lactate levels 45 minutes prior to the application of LactiGo gel and again at 5 minutes post exercise, in order to obtain pre and post Lactate values. They said that blood lactate was measured via Nova Biomedical Lactate Plus Analyzer with a finger prick at the distal phalanx of the second digit and that researchers documented a reduction in blood lactate of 1.3 mmol/l in subject 1 and a reduction of blood lactate of .8 mmol/l in subject 2 compared to the placebo condition. The advertisers said that muscle biopsies were not typically used to assess blood lactate values due to how invasive they are compared to a finger prick analyser.
The advertisers referred to Study 1, by Sharpe et al. (2016) which studied the mean time to complete the 1000m sprints in the anaerobic test, the results of which were 248.80 seconds in the no treatment group vs 239.71 seconds in the treatment group (Lactigo) for an improvement of 9.09 seconds.
Complaint Upheld In Part
The Complaints Committee considered the detail of the complaint and the advertisers’ response.
Issue 1 - Upheld:
The Committee noted that the claim made was based on a testimonial by an athlete following their experience of using the product. The Committee noted that one of the studies was a peer-reviewed study while the other was a pilot study carried out independently by a university. As the pilot study was not peer-reviewed, the Committee did not accept it as substantiation. The Committee referred to the Code requirements around the use of testimonials, particularly that testimonials did not constitute substantiation and that any opinion expressed in them should be supported, where necessary, with independent evidence of their accuracy. (Section 4.17). As evidence had not been provided to demonstrate how Study 1 supported the testimonial the Committee considered that the advertising was in breach of Sections 4.9, 4.10 and 4.17 of the Code on the grounds raised at Issue 1.
Issue 2 – Not Upheld:
The Committee noted that the claim had been based on the results of a peer-reviewed scientific journal study which had been carried out on elite athletes (soccer players). The Committee noted that the findings of the study had suggested that the product was an effective ergogenic aid able to significantly increase the performance of elite soccer players. As the claim had been made based on the results of a peer reviewed and sufficient study, in the circumstances, the Committee did not consider that the advertising was in breach of the Code on the grounds raised at Issue 2.
Issue 3 – Not Upheld:
The Committee noted that the claim had been based on the results of a peer-reviewed scientific journal study that had been carried out on elite athletes. The Committee noted that the claim made had been “up to 15% increase” and on reviewing the results of the study, noted that the results had shown an increase of up to 15%. In view of the results of the study and as the claim had been made based on the results of a peer-reviewed and sufficient study, the Committee did not consider that the advertising was in breach of the Code on the grounds raised at Issue 3.
Issue 4 - Upheld:
The Committee noted that the claim had been based on the results of Study 2, a pilot study, that while independent of the manufacturer of the product, was not a peer-reviewed scientific study. The Committee also noted that the sample size of the study was only 2 individuals. As the pilot study was not a peer-reviewed scientific study and due to the limitations of the sample size, the Committee did not accept the pilot study as sufficient substantiation for the claim. In the circumstances, the Committee considered that the advertising was in breach of Sections 4.1, 4.4, 4.9, 4.10 and 11.1 of the Code.
Issue 5 – Not Upheld:
The Committee noted that the claim had been based on the results of Study 1, a peer-reviewed scientific and sufficient study and on reviewing the results of the study, noted that the athletes included in the treatment group within the study had shown an improvement of up to 9 seconds faster. In the circumstances, the Committee did not consider that the advertising was in breach of the Code on the grounds raised at Issue 5.
The advertising should not appear in its current form again.