DIABETIKS one of first
(PRWEB) December 15, 2000
The Green Turtle Bay VitaminCo. Phone: 908-277-2240Fax: 908-273-9116Email: mail@energywave. comWebsite: http://www. EnergyWave. comDIABETIKS (http://www. EnergyWave. comDIABETIKS) one of first "Health Claims" Petitioned under New FDA InterimEnforcement StrategySummit, NJ - December 13, 2000 - The Green Turtle Bay Vitamin Co.(GTB)submitted one of the first health claim petitions under the FDA's "Interim Enforcement Strategy" announced in October on November 13, 2000 for the product "DIABETIKS." The nutrients in DIABETIKS have been chosen to supplement nutrient needs that have been shown to be deficient in many diabetics. The FDA responded that it has received the petition and will notify GTB whether it will file the petition for comprehensive review or deny the petition by Feb. 23, 2000.The FDA announced its Interim Enforcement Strategy for health claims on October 6, 2000. The FDA's previous policies regarding such claims have had to be changed due to the landmark case of Pearson vs. Shallala. Vitamin lawyer, Ralph Fucetola, JD recommends nutrient purveyors review
Potential health claims and submit them to the FDA. "While the ultimate regulation may further restrict health claims, during this interim period (and perhaps through 'grand-fathering," into the future) broad claims may very well be allowed. "Health claims" are claims which are beyond the usual general wellness or maintenance of structure and function claims but are not Medical cure claims. (www. Vitaminlawyer. com)The Green Turtle Bay Vitamin Co. was founded in 1992. It is a member of the NNFA. Richard Podell, MD and clinical professor at the Robert Wood Johnson Medical School, is the company's medical advisor.
