Special edition: Brain health

Regulation: Communicating cognitive health

By Shane Starling

- Last updated on GMT

Related tags Brain health Nutrition Euromonitor Europe European food safety authority

In the sixth article in our series on brain health, regulations governing the area are explored.

In such an emerging area as brain health, it is little wonder regulations are still grappling with best way to govern the area.

As market analyst, Euromonitor says: “Foods boosting cognitive function and mood have massive potential, but more research will be needed to overcome regulatory barriers.”

As with much that occurs in the fortified foods area – the regulation is to a large extent dependent upon the available science. It is for this reason that very few products anywhere in the world bear any brain-related health claims.

In major markets like North America and Europe, brain health claims are virtually non-existent but this may change as regulators confront the growing body of science around an ever-growing array of ingredients from omega-3s to B vitamins to herbs like ginkgo biloba​.

“The emerging category of food for the brain is likely to become part of Western society's preventative and holistic approach to health, but the role of government will be vital in making this possible,”​ say Euromonitor analysts.

“The way forward for brain foods is likely to be found in the alliance between manufacturers, government bodies and stakeholders. According to many, there is already sufficient scientific evidence to begin a campaign for healthy food products for mental health benefits.”


In the US, the Food and Drug Administration permits only one cognitive health claim – for the phosphatidylserine (PS), typically a derivative of milk.

The qualified health claim relates the ingredient with benefitting dementia in the elderly.

PS also has GRAS (generally recognized as safe) status and can be incorporated into food stuffs, but this does not allow it to make health claims and many other ingredients that have demonstrated brain health benefits in the lab also have GRAS status.


Omega-3 is another ingredient where a growing body of clinical evidence indicates mainly DHA (docosahexaenoic acid)-related cognitive benefits such as improved learning and memory, and healthy brain development in infants, but these are not yet backed by approved claims anywhere in the world.

Big players in the infant nutrition area like Mead Johnson and Martek have had omega-3 related infant cognitive development claims turned down by Europe’s science body, the European Food Safety Authority (EFSA), as Europe builds a centralised health claims list.

Given the extremely strict laws governing infant formula marketing that exist in most jurisdictions, it may be some time before brain health claims can be made to “little people”.

DHA-related infant eye health claims have however been approved by EFSA, offering hope that the lipid may win approval for brain health at some point down the line.

In the absence of such official claims, it is left for information to filter out to the public through science journals and the press, and for companies to provide information available in ways that does not contravene the law.

Claim making

The likes of omega-3 food supplements with brand names such as eyeQ, or products such as Smartfish in Scandinavia, that have positioned themselves in this way, although there are many cases of regulators censoring companies’ marketing efforts.

The Advertising Standards Authority (ASA) in the UK has pulled many companies up for making unsubstantiated claims, including a high-profile case from a few years go where a heavily backed omega-3 milk was deemed outside the law for claiming brain benefits demonstrated in a trial of English school children.

Similarly in the US, the FDA and Federal Trade Commission (FTC) have on many occasions cracked down on dietary supplements making brain health claims without formal approval.

In Japan, FOSHU (Foods for Specified Health Uses) regulations strictly control what can and can’t be said about foods, including those making mood or cognitive claims.

Confectionery giant, Ezaki Glico, markets a Gaba-fortified chocolate called ‘Mental Balance Chocolate GABA’ (gamma-aminobutyric acid), as an example of the kind statement permitted by regulators there.

To see more articles in this series, click here.

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