Making claims on eye health

This series has shown there are many studies including intervention trials that link eye health benefits with nutrients like lutein, zeaxanthin, astaxanthin, omega-3s, beta-carotene, bilberry extracts, as well as the vitamins A, C and E.

But much of this science has not translated into approved health claims, a state of affairs the industry continues to try and change by commissioning new science and presenting it to regulators globally.

Omega-3 ​

Omega-3 form DHA (docosahexaenoic acid) received a boost in December last year when the European Food Safety Authority (EFSA) issued guidance backing the fatty acid’s ability to benefit the eye health of infants.

EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) said DHA​ levels of 100mg of per day were appropriate for 7-24 month-old infants along with 200mg per day for pregnant and lactating women.

EFSA’s DHA advice can be found here​.

Lutein/zeaxanthin​

But EFSA has rejected a swathe of other eye health claims, most notably linking lutein and meso-zeaxanthin and the maintenance of normal vision, in its most recent batch of opinions.

There was a certain level of shock at these claim rejections, but the FDA, at least in regard to lutein, issued a similar rejection in 2004, citing a lack of surrogate endpoints or biomarkers to validate an age-related macular degeneration (AMD) claim as a major weakness among a Cognis submission that included 12 intervention trials.

EFSA’s lutein opinion found that while the carotenoid had the ability to raise macular pigment density, this effect did not necessarily benefit, “maintenance of normal vision”​.

The three major lutein suppliers, Kemin (along with its lutein partner DSM), Omniactive and Cognis are all working on separate, repackaged submissions under an article of the European Union nutrition and health claims regulation (13.5) they believe will give them a better chance of success.

“We believe that the company-specific submissions will offer a good opportunity for a Kemin and DSM resubmission that fine-tunes proposed claim language, reiterates the AFSSA findings, and brings EFSA’s attention to new scientific data and authoritative support, such as the Health Canada, Natural Health Products Directorate’s new monograph for lutein,”​ said Valérie de Bourayne, Kemin Europe senior regulatory affairs manager.

The “AFSSA findings”​ relate to approved lutein-eye health claims in France that remain valid and state:

• “Lutein helps protect the retina and the lens from oxidation”
• “Lutein is one (of the) constituent(s) of the retina and the lens”

But these claims are under threat if EFSA’s lutein opinions enter EU law books.

Industry has complained that EFSA's health claim assessment panel altered the claim wording to "maintenance of normal vision"​, but EFSA says is simply selected wording that reflected the science.

To read the first part in the series, ‘Unravelling the market for eye health’ ​​please click here​ .

To read the second part, ‘The science of eye health ingredients’,​​ please click here​ .

To read the third part, ‘Marigold dominates eye health ingredients supply’ ​​please click here.​