SUBSCRIBE

Breaking News on Supplements, Health & Nutrition - Europe US edition | APAC edition

Read more breaking news

 

 
EFSA health claim opinion

EFSA rejects Merck omega-3 health claim

By Shane Starling , 16-Apr-2009
Last updated on 20-Apr-2009 at 11:55 GMT2009-04-20T11:55:49Z

EFSA rejects Merck omega-3 health claim

DHA does not benefit visual or cognitive development in infants and unborn babies, according to two article 14 opinions published by the European Food Safety Authority (EFSA) today.

EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected similar dossiers containing 40+ studies, including a large number of “gold standard” trials, submitted by pharma and food giant, Merck Selbstmedikation.

In its dossiers, the German firm recommended mothers consume 200mg of DHA (docosahexaenoic acid) in the form of food supplements per day during and after pregnancy to confer the eye health and brain health benefits in the foetus and infant.

But the NDA said, “There is insufficient evidence to establish a cause and effect relationship.”

Global algae-sourced DHA leader, Martek Biosciences, had a similar DHA/ARA (arachidonic acid) dossier turned down last year, although the French arm of Mead Johnson Nutritionals had two omega-3, eye health claims approved by the NDA in March, while simultaneously having three infant brain health claims rejected.

Mead in February became the first company to have an omega-3, eye health, infant formula claim approved.

EFSA says no

The application referred to supplements that contained 50mg of EPA (eicosapentaenoic acid) and between 11.4 and 14.4 mg d-α-tocopherol, in addition to 200mg of DHA.

Merck submitted the same wording for each claim: “DHA is important for early development of the eyes/brain in the foetus (unborn child) and infant. Maternal DHA supply contributes to the child’s visual/cognitive development.”

The visual claim contained 41 studies, the brain claim, 48.

The cognitive development claim contained 25 human intervention and observational studies, three meta-analyses of human intervention studies, five systematic reviews, four other review publications, three guidelines/consensus opinions and eight mechanistic human studies.

But only seven human and observational studies were deemed relevant with EFSA taking issue with sample sizes, insignificant and inconsistent results as well as dosages that did not match those of the proposed claim.

In one randomised, clinical trial (RCT) of 29 pregnant women, the NDA said the small sample size, inconsistent findings for various intelligence tests including hand-eye coordination, problem solving and behaviour, and dose about 10 times the level of that recommended in the claim, and was therefore not “informative”.

It found similar problems with all of the other studies.

For the visual development claim, Merck submitted 15 RCT, one non-randomised controlled trial, two observational cohort studies, three meta-analyses of human intervention studies, five systematic reviews, four other review publications, three guidelines/consensus opinions and eight mechanistic human studies.

But NDA said most were not relevant.

“Intervention studies which assessed visual acuity in children who had been either breastfed or fed formula enriched with DHA are not regarded as pertinent for the substantiation of the proposed health claim, nor are RCT which describe the effects of DHA supplementation of pregnant women on the DHA concentrations in maternal and umbilical cord blood and in placenta and RCT conducted with DHA in lactating women which assess the effect on breastmilk DHA content,” it said.

Only five RCT trials and a cohort study were considered pertinent but it found them all wanting for the same reasons as described above.

The European Union is attempting to formulate a centralised list under the nutrition and health claims regulation that is due for completion in January, 2010.

To see the visual development opinion click here .

To see the cognitive development opinion click here .

Merck was unavailable for comment by the time of publication.

Related products

Live Supplier Webinars

Polyphenols tipped to become the way to innovate in Sports Nutrition
Fytexia
Alpha & Omega in Sports Nutrition – Using Omega 3’s and A-GPC to improve performance and recovery.
KD Pharma
Orally bioavailable standardized botanical derivatives in sport nutrition: special focus on recovery in post-intense physical activities
Indena
Collagen in motion: move freely and keep your injuries in check
Leading manufacturer of gelatine and collagen peptides
Life’s too short for slow proteins. Whey proteins hydrolysates: Fast delivery for enhanced performance
Arla Foods Ingredients
What it Takes to Compete and Win in Today’s Sports Nutrition Market
Capsugel
Sports Nutrition Snapshot: Key regional drivers and delivery format innovations
William Reed Business Media
Gutsy performance: How can microbiome modulation help athletes and weekend warriors
William Reed Business Media
Pushing the boundaries: Where’s the line between ‘cutting edge nutrition’ and doping
William Reed Business Media

On demand Supplier Webinars

High-amylose maize starch may reduce the risk of type 2 diabetes: what does this qualified health claim mean?
Ingredion
Balancing Innovation and Risk in Sports Nutrition Ingredients
NSF-International
Explaining bio-hacking: is there a marketing opportunity for food companies?
William Reed Business Media
Personalized Nutrition – how an industry can take part in shaping the future of Nutrition
BASF Nutrition & Health
Find out Nutritional and ingredient lifecycle solutions and strategies!
Roquette
Is the time rIpe for I-nutrition?
William Reed Business Media
The Advantage of Outsourcing Fermentation-based Manufacturing Processes
Evonik Health Care
All supplier webinars