For Immediate Release

Contact:
Karen Horbatt, President
908-277-2240

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."

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."

08/28/01