Forgettable science: EFSA rejects DSM health claim for DHA & memory
DSM submitted 15 human intervention studies and 13 observational studies as well as three meta-analyses using data from the intervention studies, yet only 11 human intervention studies made it past EFSA’s rigour.
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) acknowledged that two of these 11 human intervention studies showed a beneficial effect of docosahexaenoic acid (DHA) supplementation on memory function.
However one study showed inconsistent results, while another showed a negative effect on memory function and seven did not show an effect on memory outcomes.
“The Panel considers that the majority of the human intervention studies provided did not show an effect of DHA supplementation on memory, and that the conflicting results across studies cannot be explained by differences in the study design, the source of DHA, the DHA dose, the baseline characteristics of the subjects recruited, or the duration of the studies,” EFSA wrote in its opinion.
DSM said it "regrets the negative opinion".
"With more than 30,000 published scientific papers, omega-3 fatty acids are the most studied nutrients to date. DSM continues to actively engage in partnering with organisations around the world to support
scientific research into DHA," the company said in a statement.
"In particular, the recent meta-analysis points to the need for additional long-term intervention studies examining the roles that DHA may play in supporting other aspects of cognition
such as semantic and working memory in older adults. We are confident that this will expand the already stable research platform."
The missing memory claim
There are nine approved health claims for DHA in Europe concerning normal brain function, vision, infant development, heart function and blood pressure.
Yet there are currently no approved claims for memory in Europe for DHA or beyond.
When EFSA started looking at DSM’s article 13.5 claim last July, the company told us a claim specific to memory was important because the already approved DHA brain claim was still too ‘generic’ to hold weight with consumers.
“A specific health claim related to memory seems to us important in a demographic situation with an ageing population where memory loss is one of the concerns of the elderly generation.
“This benefit of DHA related to the health claim can be translated into better remembering names, telephone numbers, etc. – things people relate to.”
Memory was the ninth biggest health positioning for food supplements in Western Europe in 2015, cashing in a retail value of $240m (€213.94m), according to Euromonitor International data.
The top specific positionings in the region are digestive health ($761.6m; €678.91m), general health ($732.6m; €653.06m) and immune health ($586.3m; €522.64m).
Yet the precedent for memory claims was against DSM, with 28 memory claims rejected so far.
This includes one from UK company Vifor Pharma for its product Eye q – a combination of eicosapentaenoic acid (EPA), DHA and gamma-linolenic acid (GLA) – and the improvement of ‘working memory’ in children, which was rejected because of a failure to establish a “biologically plausible mechanism” .
DSM says DHA is an essential structural component of nervous tissue shown to enhance neurotransmission via increased synaptic plasticity.
The claim conditions targeted a population of healthy adults aged over 45 with a daily dose of a minimum of 1 g DHA and EPA, of which a minimum of 580 mg must be DHA.
DSM manufactures its omega-3 brand life’s DHA – acquired from Martek Biosciences for €830m in 2011 – from algae. It appears in foods, drinks and food supplements globally.