“It is not a big surprise even if it is very sad,” Dr Ake Lignell, the general manager of Fuji Chemical Industry’s Swedish subsidiary, BioReal, told NutraIngredients. “We are very disappointed with the outcome and the procedure but we will evaluate the opinion with our regulatory consultants to see how to best proceed to apply for a health claim based on earlier data and new data that have been developed during the last year. We don´t give up yet.”
"But other carotenoids have not performed much better."
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) article 13 opinion – one of 73 delivered last week – found causality had not been demonstrated between astaxanthin and protectingthe skin from UV-induced damage; defence against Helicobacter pylori; normal spermatogenesis and normal muscle function.
The dossier was spare of gold standard, human studies, making approval difficult given the NDA’s preference for human, clinical data.
For the skin claim, an open label, uncontrolled human intervention study which investigated the effects of astaxanthin consumption (4mg/day) for two weeks in 21 healthy male and female subjects, was deemed irrelevant due to the lack of a control group.
An immunity claim was deemed too general and these latest rejections came on the back of an NDA 2009 rejection of astaxanthin’s ability to deliver joint, antioxidant, eye or cholesterol benefits.
However the rejections do not appear to be denting the astaxanthin market, with BioReal and leading Israeli supplier, Algaltechnologies, announcing production capacity expansions this year of 100% and 80% respectively. Hawaiian supplier, Cyanotech has also reported buoyant sales in a global market estimated to be worth between $35m-$60m by Frost & Sullivan in 2008.
Algatechnologies director of marketing and sales, Efrat Kat, said her company was studying the opinion but pointed to ongoing research.
“For some applications, mainly pre-clinical studies are available and therefore there is a need to further investigate in order to reapply for a health claim,” she said. “But in general, we can say that it is a well known fact supported by scientific evidence that natural astaxanthin is one of the most potent antioxidants in nature.”
The latest NDA opinion astaxanthin opinion can be found here.
Beauty From Within conference
Carotenoids, health claims, marketing strategies and more will go under the microscope at the 2nd Beauty from Within 2011 Conference, to be held in Paris on October 27, where key figures will unlock key challenges in the nascent multi-billion dollar, global nutricosmetic industry.
For more speaker and programme information and to book your delegate place please email email@example.com