EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) issued a negative opinion on the article 14 claim in October last year, chiefly because the research submitted in Dutch supplement maker Dr Hittich’s dossier was not conducted on healthy populations the claim targeted.
No legal basis
Representing an unnamed German supplements manufacturer, Chrisitan Ballke of the Munich-based legal firm, Meyer Meiserernst, wrote in a letter to the European Commission that, “the definition of the target population and the assessment of the evidence provided are questionable”.
Ballke added: “…there is no legal basis for the approach by EFSA to concentrate solely on the assumed target population”.
He said the regulation did not require applicants to indicate a specific target population and no reason for EFSA to concentrate solely on an assumed population.
While article 6(a) of the 2006 nutrition and health claims regulation required a specific population it was only in regard to the specific conditions for use of the claim, not the actual meaning of the claim, which article 15 (3) indicated were not mandatory.
The target population of the claim was males and females older than 40 years and the proposed dosage was one 600mg tablet of glucosamine hydrochloride per day for six months to have the osteoarthritis risk-reducing effect.
Ballke’s letter highlighted previous EFSA positive opinions for ALA (alpha-linolenic acid) and brain health; vitamin A and the immune system and EPA (eicosapentaenoic acid ) and DHA (docosahexaenoic acid) and blood triglycerides that showed EFSA did on occasion extrapolate results from specific to healthy populations.
“These examples show that EFSA regularly extrapolates studies conducted with patients and which therefore are not representative of the target population,” he continued. “We do not see a substantiated reason why the proposed health claim related to glucosamine hydrochloride and a reduced rate of cartilage degeneration and reduced risk of development of osteoarthritis should be treated differently.”
EFSA also rejected an article 13.1 glucosamine-joint health/joint support claim in October. In that opinion the NDA stated:
“In weighing the evidence, the Panel took into account that the evidence provided does not establish that patients with osteoarthritis are representative of the general population with respect to the status of joint tissues, or that results obtained in studies on subjects with osteoarthritis can be extrapolated to the maintenance of normal joints in the general population.”
That opinion can be found here.