For Immediate Release
Contact: Karen Horbatt, President
FDA PERMITS DIABETIKS™ BRAND NAME
August 21, 2001 – Summit, NJ. The Federal Food and Drug Administration, through its Office of Nutritional Products, Labeling and Dietary Supplements, issued a letter ruling today permitting The Green Turtle Bay Vitamin Co. to continue to use its brand name Diabetiksä although it “names” a disease, diabetes, and under former FDA rulings might not have been permitted.
Karen Horbatt, president of the Summit, NJ based nutrient purveyor, stated, “This quick, positive decision on the part of the FDA to permit us to continue the use of our brand name shows that a new awareness is permeating the agency. There is an understanding that dietary supplements have an important role in the nutritional support of people with chronic conditions like diabetes. It shows the FDA is serious about a new approach to nutrient claims, in the new political climate where ‘freedom of choice’ is not just another slogan. We are very pleased by the FDA action.”
Robert J. Moore, Ph.D., Chief of the FDA’s Division of Compliance and Enforcement wrote to Ms. Horbatt, “Based on the information in your letter, it appears that the statement you proposed to include in your labeling would adequately address… [our] concerns… The addition of the statement appears to add appropriate context to the labeling to establish that the product is not necessarily intended to treat or mitigate diabetes, but instead is intended to meet specific nutritional needs of persons with diabetes.”
The claims statement accepted by the FDA reads, “Intended to supplement nutrient needs of persons with diabetes, addressing certain nutrient deficiencies found in some diabetics, without affecting the blood sugar or treating diabetes.”
Ms. Horbatt explained that the language had been crafted by the company’s attorney, Ralph Fucetola, JD, the renowned Vitamin Lawyer, www.vitaminlawyer.com.
Diabetiks was formulated with the guidance of Richard Podell, MD, clinical professor at New Jersey’s Robert Wood Johnson Medical School. Ms. Horbatt concluded, “We hope that all diabetics and their organizations will feel empowered by this ruling to view proper dietary supplementation as an integral part of managing diabetes.”