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EFSA health claim opinions

EFSA rejects glucosamine, coffee, diacylglycerol (DAG) oil health claims

1 commentBy Shane Starling , 07-Dec-2011
Last updated the 08-Dec-2011 at 10:22 GMT

The European Food Safety Authority (EFSA) has sent an ominous warning that recently-submitted health claim dossiers will fare any better than those that have gone before, with three fresh article 13.5 rejections.

Glucosamine (joint health), a coffee extract (DNA protection) and diacylglycerol (DAG) oil (weight management) were all rebuffed by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA).

Given the swathe of article 13.5 applications that have been arriving in the NDI’s inbox, hopeful to have applied learnings from more than 3000 opinions over three years, not to mention summits and guidelines, these three rejections, in particular the glucosamine opinion, will appear disturbing to industry.

However closer inspection reveals the dossiers to be lacking in real power.

Glucosamine

The glucosamine dossier submitted by Hungarian firm Béres Pharmaceuticals Ltd contained just two human intervention trials that the HND deemed relevant – one of which was conducted among a diseased population, the other was uncontrolled and provided inconclusive data, according to the NDA.

That opinion can be found here.

Coffee extracts

German firm Tchibo GmbH sought to link a reduction in ‘spontaneous DNA strand breaks’ and its coffee C21 extract. The NDA found one human study was not adequately controlled for confounding factors while other studies researched coffees but not coffee C21 and supporting animal and in vitro data was inconclusive.

That opinion can be found here.

DAG

A European subsidiary of Japanese company Kao Corporation proposed that diacylglycerol (DAG) oil could benefit weight loss when replacing vegetable oils. Kao highlighted seven randomised controlled trials (RCTs), but the NDA said six of the studies gave inconsistent and unconvincing results. The other had methodological limitatations.

An unpublished meta-analysis, “had a number of potential sources of bias and did not provide additional information for the scientific substantiation of the claim.”

That opinion can be found here.

The companies were not available at the time of publication.

The Béres dossier proposed the claim: “glucosamine sodium sulphate contributes to the protection of joint cartilage exposed to excessive motion or loading and helps to improve the range of motion in joints”.

Statements on the Béres website that may soon require changing include claims that its supplements could:

 

  • ease mild and moderately severe symptoms of the degenerative changes in the knee joint
  • ease the symptoms of osteoarthritis in the knee joint

1 comment (Comments are now closed)

DAG

After reviewing the published DAG/MAG data myself, a lifelong industrial chemist, I find the rejection unreasonable. Both are intermediates in normal fat metabolism of dietary TAG's via in vivo enzymes in both energy production and storage. Replacing TAGs with DAG/MAG made ex vivo by the same enzymes eliminates the enzyme limited physiological conversion of TAGs which, if in excess of dietary needs, would be stored as body fat, ergo weight gain.
Regardless of the decision, consuming DAG/MAG, eg as found in some "reduced fat" cheeses, is advisable for weight control. Regrettably, the DAG/MA enriched Enova oil is no longer readily available in the USA.

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Posted by Herman Rutner
07 December 2011 | 17h29

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