Chrysantis' EZ Eyes accepted as NDI

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Related tags: Macular degeneration, Dietary supplement

Chrysantis is ready to start selling EZ Eyes to dietary supplement
makers following the FDA's acceptance of the marigold-derived
natural zeaxanthin as a new dietary ingredient (NDI), reports
Jess Halliday.

The company announced the launch of EZ Eyes in March, following the Ball Horticultural subsidiary's development of Marigolds with carotenoid profiles ranging from 75 percent zeaxanthin and 5 percent lutein to 50 percent zeaxanthin and 50 percent lutein. Most marigolds have a carotenoid profile of 80 percent lutein to 5 percent zeaxanthin.

Like lutein, zeaxanthin is a dietary carotenoid found in the macula, the central part of the retina in the eye that is responsible for most fine vision.

According to Chrysantis general manager Manuel Pavon, zeaxanthin is a better antioxidant than lutein, is better at absorbing blue light and is also very good at protecting tissues from the products of lipid oxidation.

He said recent research has also indicated that zeaxanthin supplementation is especially important for women and individuals who are overweight, a finding that means it could make its way into a broader range of supplement formulas.

The Dietary Supplements Health and Education Act requires that NDI applications must be submitted to the FDA at least 75 days prior to the market introduction of any supplement ingredient not marketed in the United States before October 15 2005.

Anthony Almada of ImagiNutrition, which assisted Chrysantis in its NDI submission with the provision of biomedical research support from its database, pointed out that less than 30 percent of NDI applications receive a favorable response.

However this low proportion does not mean that the majority of proposed NDIs are unsafe. Rather, their rejection is most often due to the submission of incomplete information.

The American Herbal Products Association (AHPA) has been actively encouraging the FDA to tighten up the NDI notification process, so that companies are clearer about what is required and can reduce the number of unnecessary or inadequate submissions made.

In comments sent to the administration in February, it said it would like to see fewer dietary ingredients that are not new put forward for pre-market notification and suggest that its Herbs of Commerce publication may be a useful source document for companies.

Contrary to the FDA's stance, AHPA maintains that an ingredient's "chemical composition"​ or "active components"​ should be disclosed in its notification. It also advocates the identification of a botanical's Latin binomial, author, and part.

Chrysantis' application comprised toxicology and epidemiological studies demonstrating the safety of zeaxanthin at the recommended dosage. The FDA said that the information submitted provides a "reasonable basis for the ingredient to be considered safe".

In April the company signed a licensing agreement with ZeaVision for the marketing and selling of zeaxanthin, which gives it limited, non-exclusive license store of the supplement maker's patents on the use of zeaxanthin in supplements and food products.

ZeaVision is currently launching a new line of products called EyePromise to help prevent age-related macular degeneration (AMD).

AMD is a progressive eye disease that affects the central macula of the eye leaving sufferers with only peripheral vision. It affects more than 10 million adults in the United States and is the leading cause of blindness amongst over-55s.

Related topics: Eye health

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