EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found causality had not been demonstrated between glucosamine, either as glucosamine hydrochloride or as glucosamine sulphate, alone or in combination with chondroitin sulphate and the claim of maintenance of joints and reduction of inflammation.
Glucosamine is not present in significant amounts in most diets, with supplemental sources derived from the shells of shrimp, lobster, and crab, or it may be synthesized.
Dr Julian Domszy, technical manager at UK supplier Gee Lawson expressed his disappointment at the judgement.
While he does not foresee any negative market impact arising from the glucosamine judgement in the short term as current users have found from their own direct experience that the compound works for them, he anticipates that long term it could dent sales with future generations.
However, Bio-Health, another UK based supplement supplier, agrees with the regulatory approach and does not anticipate any fall off in sales for its glucosamine product in relation to this judgment because “we make no claim for efficacy at all as the law requires.’
Victor Perfitt, technical director at the company, told NutraIngredients.com that ‘on balance, the EFSA opinion is sensible and is aimed at eliminating misinformation on the part of marketing departments.”
He maintains that if a company starts making claims for a product that it can treat adverse conditions, then it has to call it a medicine and thus seek a medicinal licence to back those assertions.
“Dietary health claims are for the general population, as clearly set out in the scientific opinion.
This means without equivocation that an individual or a company cannot extrapolate from evidence that Glucosamine HCL, which is effective at treating osteo-arthritis, that it is per se good for maintaining general joint health,” he added.
Meanwhile, Domszy further highlighted the business disadvantage that can result from opinions being issued at different times, be they either negative or positive.
“We are concerned about the commercial impact of the regulatory approach,” he told this publication.
“A staggered method of claims publication means that some products can ride out the process for longer than others. We believe that EFSA should have held off publishing any of its opinions until they were all processed,” he said.
However, health claims expert, Nigel Baldwin, the senior scientific and regulatory consultant and EU manager at Cantox Health Sciences International, disagrees saying EFSA should go ahead and publish its opinions as they are finalised.
“It is important to see these opinions sooner rather than later so the debate on how EFSA will assess them can be concluded because clearly they have opinions ready and are unlikely to change them,” he said.
In terms of scientific substantiation of the claimed effect the panel considered that:
“the evidence provided does not establish that patients with osteo-arthritis (OA) are representative of the general population with regard to the status of joint tissues, or that results obtained in studies on subjects with OA relating to the treatment of symptoms of this disease (e.g. erosion of articular cartilage, reduced mobility of joints) can be extrapolated to the maintenance of normal joints in the general population.
The Panel also considers that the evidence provided in the animal and in vitro studiessubmitted ‘does not predict the occurrence of an effect of either chondroitin or coindrintin sulphate intake on the maintenance of normal joints in humans.
Healthy group studies
Cedric Bourges-Sevenier, the general manager at French claims and research consultancy, NutraVeris, said EFSA’s failure to support glucosamine and chondroitin’s ability to benefit joint health “is potentially devastating for the market”.
“But this opinion is not such a shock because the studies were not conducted on healthy populations and EFSA has made it clear this is required,” he said.