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FDA’s s Safety Review: Summary• Separate consults w/ NCI (Dr. Greenwald) re:carotenoids, and NEI (Dr. Kupfer) re: no maculardegeneration potential• Assembling of FDA’s Food Advisory Committee(4 days in November 1995)• Special Labeling required (to preclude productmisbranding in the marketplace; interimrequirement)• Use of passive and active post market surveillance• Final regulation published FR January 30, 1996• Second FAC June 1998• Labeling requirement rescinded, FR August 2003