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Rejected Merck to present glucosamine data for peer review

1 commentBy Shane Starling , 17-Aug-2012
Last updated on 20-Aug-2012 at 00:57 GMT2012-08-20T00:57:10Z

Rejected Merck to present glucosamine data for peer review

“Disappointed” Merck Consumer Healthcare says it will submit a summary of glucosamine science to a scientific journal, after its joint health claim appeal was rebuffed by the European Food Safety Authority (EFSA).

EFSA’s Dietetic Products, Nutrition and Allergies (NDA) panel dismissed Merck’s appeal that argued its submission should have been accepted on the grounds that:

  • its healthy versus diseased study population data was valid
  • bioavailability data was valid
  • biomarkers and demonstration of physical effects were valid.

The NDA initially 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 JointCare that it sells under its Seven Seas brand in many European countries.

This Merck rejection follows a 2009 article 13.1, general function NDA opinion that concluded 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 giant 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?” Coppens observed.

1 comment (Comments are now closed)

Efficacy of supplements, health claims are not black or white

Perhaps that is the problem with the ridiculous state of affairs that is EFSA opinions; they should look for grey areas instead of black or white (= yes or no). If the EFSA were to rank efficacy, say, between 1 and 10, so water solves thirst = 10 but other remedies may be less absolute and earn a 5 or even a 1. The consumer can then decide if this is effective enough to spend money on it! The present solution seem to mollycoddle the public, while alienating academia to boot!

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Posted by Hans
17 August 2012 | 15h202012-08-17T15:20:35Z

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