The two drug ingredients, Sibutramine and Phenolphthalein, have been classified as controlled substances and were removed from the market for safety reasons.
The supplement has not yet been approved by the FDA, but is marketed as a natural herb, manufactured with a pharmaceutical & Nutraceuticals laboratory and sold directly to individual customers in the firm’s New York sales office and online.
FDA said that the products may pose a threat to consumers like substantial increase in blood pressure and/or pulse rate in some patients and may also interact, in life-threatening ways, with other medications.
The company said that it remains committed to the health and safety of its customers and is working diligently to make available an appropriate Natural Herbal replacement product manufactured in the US.