Posted September 7, 2002

FDA Sends Warning Letters to Seven Online Supplement Sellers For Therapeutic Claims

On August 27, 2002, the FDA posted seven "Cyber" letters recently issued from its Center for Food Safety and Applied Nutrition (CFSAN) to internet website operators promoting dietary supplement products that claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. Claims of this nature are generally only permitted for drugs and not dietary supplements.

The letters, sent by the FDA's Center for Food Safety and Applied Nutrition, warn these website operators that they may be engaged in illegal activities. The letters also note, however, that many of these products may be legally marketed as dietary supplements or as cosmetics if therapeutic claims are removed from the promotional materials and the products otherwise comply with FDA regulations.

Between July 31 and August 13, 2002, letters were sent to the following Website operators regarding the products noted below:

New Horizons (operating behealthy.com): Bioumune OSF Plus, Km by Matol Botanical International, Bovine Colostrum, and Olive Leaf Extract

Herbal Healer Academy, Inc. (operating herbalhealer.com): Citricidal, 5-HTP Capsules, MYOMIN, STOPSMO, SHARK CARTILAGE, ASPARAGUS EXTRACT, COQ10, MSM SULPHUR, INTESTINAL FREEDOM, HHA GLUCOSAMINE/CHONDROITIN, ST. JOHN’S WORT, and HHA NATURAL RELIEF

SmartBodyz Nutrition (operating dietsexercise.com): Drinkables Liquid Joint Care and Repair, Flax Seed Oil, Acetyl-L-Carnitine, and BHT

Hawaiian Island Noni (operating energyforlife.com): Hawaiian Island Noni

HEAL Marketplace (operating shepherds-rod.org/HEAL): Herbal Anti-Depressant Formula, Herbal Antibiotic, Brain Formula and Heart Tonic

Optimal Health Concepts (operating intohealth.com): Herp-Eeze, Red Marine Algae Complex, MSM, and FlexMax Glucosamine Sulfate

Jagulana Herbal Products (operating immortalityherb.com and jiaogulan.net): Jiaogulan

For more details, the letters can be accessed from the FDA web address shown below. Also available are Cyber letters sent to other web site operators earlier this year and in prior years.