FDA WARNING_LETTER - Dolphin Intertrade Corporation - May 17, 2013

The FDA issued a Warning Letter to Dolphin Intertrade Corporation following an inspection from May 10-17, 2013, and review of their website, www.jadera.net. The FDA determined that Jadera and Xiyouji Qingzhi, marketed as dietary supplements, are unapproved new drugs and misbranded drugs.

Laboratory analyses confirmed both products contain undeclared sibutramine, an active pharmaceutical ingredient in Meridia, which was withdrawn from the U.S. market in 2010 due to increased risks of heart attack and stroke. Sibutramine is excluded from the definition of a dietary supplement because it was authorized for investigation as a new drug before being marketed as a dietary supplement or food.

Jadera and Xiyouji Qingzhi are considered drugs due to their intended uses, such as "Lose Weight Effectively" and "Curb Your Appetite," and are new drugs as they are not generally recognized as safe and effective. Their distribution without FDA-approved applications violates sections 301(d) and 505(a) of the Act.

Furthermore, the products are misbranded under section 502(f)(1) for lacking adequate directions for use, as sibutramine requires professional supervision and was withdrawn due to safety risks. They are also misbranded under section 502(a) for false and misleading safety statements and failure to disclose material facts, and under section 5