· its healthy versus diseased study population data was valid
· bioavailability data was valid
· biomarkers and demonstration of physical effects were valid.
The NDA rejected Merck’s glucosamine-joint health claim in May this year. The company did not indicate how the decision may affect marketing around products like the JointCare it sells under its Seven Seas in many European countries.
This Merck rejection follows a 2009 article 13.1 general function opinion that glucosamine does not benefit the normal function of joints, either alone or in conjunction with typical food supplement stable mate, chondroitin.
61 references
"We are disappointed upon receiving a negative opinion on the health claim submission for glucosamine,” said Dr Udit Batra, head of Consumer Health at Merck.
“We strongly believe in the benefits of glucosamine on joint cartilage. The research we have conducted includes 61 references and is based on extrapolated data obtained from osteoarthritic patients as well as healthy people.”
“We will continue to discuss with EFSA to make claims viable for consumers. In addition to this, we plan on publishing a summary of the beneficial impact of glucosamine in a scientific journal."
The German pharma and did not expand on the journal or the timing of publication.
Patrick Coppens, the secretary general of the Euroepan Responsible Nutrition Alliance (ERNA) said the NDA appeal rejection was not surprising given the panel’s track record that has seen it change only one opinion – for prunes and stool transit.
“It is very rare for the NDA panel to change its opinion, especially in a system where it is only permitted to give ‘yes’ or ‘no’ verdicts and has therefore not yet issued one qualified opinion,” he said.
He said this state of affairs was unlikely to change, even now that the NDA panel of 20 has nine new members.
“The principles the panel is following are the same so why should new panelists make any difference?”
