U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Nutritional Products, Labeling, and Dietary Supplements
November 19, 2001

Letter to Distributor on Hazardous Dietary Supplement LipoKinetix

By Certified Mail

Mr. Derek W. Cornelius
Syntrax Innovations, Inc.
145 Yoakum Avenue
Chaffee, Missouri 63740

Dear Mr. Cornelius:

Your product LipoKinetix has been implicated in a number of serious adverse reactions, specifically serious liver injuries. Our evaluation of the complaints of serious injuries associated with the use of LipoKinetix shows that it is associated with acute hepatitis when used under the conditions of use recommended on the label. The Food and Drug Administration (FDA) has received multiple reports of persons who developed acute hepatitis and/or liver failure with the use of LipoKinetix.

Given the serious hazard presented by the use of your product, we strongly recommend that you take prompt action to remove LipoKinetix from the market. Further, FDA urges you to alert your customers to immediately stop using LipoKinetix. Toward this end, FDA has issued a consumer warning to alert consumers to the serious risks presented by the use of your product, LipoKinetix. A copy of the consumer alert is enclosed.

Should you have any questions or require any FDA assistance, contact Robert Moore, Ph.D., of my staff at (202) 205-4605.

Sincerely yours, Christine Lewis Taylor, Ph.D. Director Office of Nutritional Products, Labeling and Dietary Supplements Center for Food Safety and Applied Nutrition

FDA Warns Consumers Not to Use the Dietary Supplement LipoKinetix

Letter to Health Care Professionals on Hazardous Dietary Supplement LipoKinetix

Hypertext updated by cjm 2001-NOV-16