Lutein given FDA and JEFCA backing as safe ingredient

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Related tags: Food additive, Dietary supplement, Antioxidant

The FDA has confirmed the Joint Expert Committee on Food Additives'
(JEFCA) ruling in June that free lutein and zeaxanthin are safe for
human consumption - a move welcomed by Kemin Foods which produces
the ingredient FloraGlo Lutein.

The JEFCA decided at a joint FAO/WHO meeting in Geneva, Switzerland earlier this year that it had no concerns over the consumption of lutein/zeaxanthin if consumers kept their intake to an acceptable daily level.

The scientific advisory body concluded - after reviewing toxicological and other data on safe use of lutein/zeaxanthin as derived from marigold flowers (Tagetes erecta) - that the maximum acceptable daily intake level is two mg per kg of body weight. Hence, for a 160 lb person (72.6 kg), that would mean an intake of approximately 145 mg of lutein/zeaxanthin.

Although Rodney Ausisch, president of Kemin Foods, acknowledged that "many health and nutition researchers have suggested taking six to 20 mg of lutein"​, he agreed that the JECFA's findings support the general premise that "supplemental free lutein is accepted as a safe compound for the human diet"​.

Moreover, Ausisch welcomed the letter of non-objection from the FDA regarding the food and beverage categories for which Kemin's FloraGlo Lutein has achieved GRAS (Generally Recognized as Safe) status.

"The FDA letter is yet more evidence of FloraGLO Lutein's safety as a food ingredient,"​ said Ausich.

JECFA serves as the scientific advisory body to the Codex Alimentarius Commission, which, like JECFA, is administered by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). The role of the expert scientific committee is to 'address the technical and administrative aspects of chemical additives and their safety in food.'

The lutein/zeaxanthin acceptable daily intake level was put forth in the report from the JECFA 63rd Meeting in Geneva, Switzerland 8-17 June, where ingredients and additive experts met to discuss the safety of a host of flavouring agents and the construction of further principles for setting the safety levels of food additives.

Food additives under discussion at the meeting included benzoyl peroxide, a-cyclodextrin, lutein from Tagetes erecta L., D-tagatose, and zeaxanthin.

So far JECFA has evaluated more than 1300 food additives, approximately 25 contaminants and naturally occurring toxicants, and residues of about 80 veterinary drugs. The committee has also developed principles for the safety assessment of chemicals in food that are consistent with 'current thinking on risk assessment and take account of recent developments in toxicology and other relevant sciences.'

FloraGlo Lutein is a purified antioxidant ingredient used by nutritional supplement, food and beverage companies worldwide.

Several studies have linked natural antioxidant lutein with eye-health benefits, namely with reducing the risk of age-related macular degeneration and cataracts. Recent research has suggested that lutein may promote healthy skin as it appears to quench free radicals that may lead to oxidative stress that can damage cells in these tissues.

While still one of the newest carotenoids to become available to food and supplement makers, sales of lutein are growing rapidly.

Related topics: Regulation

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