The U.S. Food and Drug Administration has disclosed PRock Marketing LLC would recall all Fruta Planta weight loss products, after testing confirmed they contained sibutramine, a drug withdrawn from the market for safety reasons.
According to the FDA, PRock, a branding and distribution company, is recalling Fruta Planta and Reduce Weight Fruta Planta. The FDA said it has received "multiple reports of adverse events" associated with the use of the products, including several cardiac events and one death.
The FDA advised consumers halt use of the product "immediately" and throw it away in a sealed container to avoid consumption. Consumers who have experienced any negative side effects were advised to consult a health care professional.
PRock's recall notice recommends consumers destroy the product or return it to the company. Consumers may reach PRock at 1-877-225-1009.
According to a website where the product was sold, Fruta Planta was an "all natural organic" Chinese weight loss drug that touted its ability to eliminate body fat, saying users could lose up to 15 pounds in the first month without diet or exercise. Fruta Planta was marketed as a product that could boost metabolism, curb appetite and cut food cravings.
A notice on the website said that the FDA had not directly contacted the company to obtain testing samples and therefore said it could not confirm if the "authentic formula" was in fact consumed. Efforts to reach the company were initially unsuccessful.
The disclosure came after the FDA sent a letter to dietary-supplement makers earlier this month expressing concern about improperly labeled products with substances that don't qualify as dietary ingredients. The FDA has alerted consumers to at least 300 tainted products marketed to dietary supplements in recent years and received numerous injury complaints related to them.
Unlike drugs, dietary supplements don't require FDA approval, though manufacturers and distributors are responsible for selling a safe product.