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FDA acknowledges
GRAS notification for BASF synthetic lycopene MOUNT OLIVE, N.J., August 21, 2003 – The U.S. Food and Drug Administration (FDA) has acknowledged that BASF provided sufficient information to conclude that its synthetic lycopene is a Generally Recognized As Safe (GRAS) substance. Substances directly added to foods like BASF's lycopene must either be GRAS or the subject of a food additive petition. BASF followed FDA-proposed procedures to establish that its lycopene product is GRAS. This process included convening an expert panel to review the necessary product data, and then submitting a voluntary notification to FDA of the expert opinion and the data supporting its conclusion. FDA's response to the notification offered no questions that BASF's synthetic lycopene is GRAS. BASF's Human Nutrition business offers three commercial synthetic lycopene products: Lycopene 10 Percent (tablet grade, powder), Lycopene 10 Cold Water Dispersion (powder) and Lycopene Dispersion 20 Percent (liquid). Typical uses for these materials include nutritional dietary supplement tablets and as a direct ingredient to fortify various commercial food and drink products. "Scientific evidence is beginning to indicate that lycopene may reduce the risk of many types of cancers and cardiovascular disease," said Mike Doyle, Director, Human Nutrition, BASF Corporation. "Receiving this positive acknowledgment to our GRAS notification from the FDA culminates a 10-year developmental product safety evaluation project for BASF to provide high-purity lycopene to the marketplace. We will continue to support our customers in incorporating this potent nutritional antioxidant into their products that will benefit consumers." Natural sources of lycopene
include certain vegetables, especially tomatoes, and fruit, such as watermelon,
pink grapefruit and apricots. However, people would have to eat massive quantities
to provide the concentration recommended by researchers, said Dr. Herbert Woolf,
Technical Manager, Nutraceuticals, BASF. "For example, vegetarians, who
have a low incidence of prostate cancer, consume about 14 milligrams of lycopene
daily. In contrast, the average American diet provides about 7 milligrams of
lycopene daily. For many Americans not consuming a balanced diet, the next best
way to get the benefits of lycopene is to consume a lycopene supplement or processed
foods fortified with lycopene," he said. BASF: Helping Make
Products Better™ For more information,
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