The article 13.5 submission under the EU nutrition and health claims regulation (NHCR) sought to link beta-alanine and increased physical performance during short-duration, high-intensity exercise.
It was submitted by US-based nutritional supplement manufacturer Natural Alternative International (NAI), for its patented CarnoSyn beta-alanine product but the European Food Safety Authority (EFSA) rejected it this month despite dialogue with the applicant in a stop-the-clock procedure.
EFSA's Panel on Dietetic Products, Nutrition and Allergies (NDA) had previously rejected the amino acid for a range of performance-based outcomes in 2010 under the NHCR's general function article 13.1.
But NAI and Legal Foods were confident they had cracked the NHCR claims code with refined wording and new studies.
Mark LeDoux, chairman and CEO of NAI, told NutraIngredients his firm was, “disappointed at the outcome rendered through this cumbersome process in the face of overwhelming scientific evidence.”
He said NAI would review its options in, “pursuing relief from this misguided opinion”.
Mark Tallon, managing director of Legal Foods, which represented NAI throughout the process, criticised the NDA for assessing studies that were irrelevant to the application.
In its dossier, NAI identified four human studies in support of its claim, and which also reported on muscle carnosine - the proposed mechanism for the effect. EFSA extended its review to include an additional 13 human studies on the basis that it had to consider, “all available studies on the effects of beta-alanine on physical performance, which did and did not report on muscle carnosine”.
Exclusion criteria discounted
This meant EFSA’s opinion was based on studies NAI and Legal Foods had rejected under the exclusion criteria submitted to EFSA as part of its dossier.
“EFSA’s unwillingness to give a reason as to why they accepted all exclusion criteria except one [studies must have measured muscle carnosine] resulted in EFSA assessing studies that were not appropriate within the framework of the health claims regulation to support a cause and effect relationship”, said Tallon.
He added EFSA was fully aware of the study inclusion and exclusion criteria NAI applied in its submission, yet provided no valid rationale as to why it refused to accept some criteria and not others.
Furthermore he said EFSA’s failure to inform NAI that it was going to reject primary study data and insert studies NAI had already rejected, resulted in NAI having no chance to alter the submission, discuss the issues with EFSA, or even withdraw the application.
“We believe such action is tantamount to maladministration of EFSA’s role and goes beyond those powers conferred to them under the NHCR. We will be challenging the opinion and assessment of the submission under all routes available to us."
Eight of the 17 studies EFSA reviewed were discounted because the panel noted that they, “assessed measures of physical capacity, for example time to exhaustion, [...] and did not include any measures of physical performance”.
Tallon questioned EFSA’s rejection of studies on this basis, saying: “There is no justification for using such study discrimination based on EFSA’s view over the nomenclature of health claim wording. If you have to complete a 50km bike course at a set power output but become exhausted and stop before the end, but then, after a few weeks of supplementation you do the same trial again and can hold that same power for the full 50km course, is that not a performance enhancement? According to EFSA, it is not.”
ISSN: Opinion is ‘flat-out wrong’
This opinion has ruffled more feathers than just those of the applicant. The International Society of Sports Nutrition (ISSN) has also felt compelled to speak out in defence of the amino acid that is used widely by athletes who engage in high intensity sports.
“EFSA’s assessment of beta-alanine is just flat-out wrong,” said Jose Antonio, co-founder of the ISSN. “The data on beta-alanine’s ergogenic effects are quite robust. Certainly there are more than a dozen studies showing that beta-alanine is one of the most effective sports supplements on the market. Only caffeine and creatine have more supportive data.”
Legal Foods is currently drafting a submission to the European Commission outlining its concerns over the opinion and what it refers to as EFSA’s, “failure to fully engage during the submissions process”.
“We hope the Commission will take our concerns on board and instruct EFSA to ultimately reassess the studies we submitted to EFSA and not studies we had already rejected."
The NDA opinion is here.