FDA WARNING_LETTER - Seeds of Light Enterprises

The FDA issued a Warning Letter to Seeds of Light Enterprises, Inc. on October 15, 2015, following a review of their website, www.slimeast.com. The letter states that the company offers "Meizi Super Power Fruits," which is an unapproved new drug and a misbranded drug.

Laboratory analysis confirmed "Meizi Super Power Fruits" contains sibutramine, an active pharmaceutical ingredient in Meridia, a drug withdrawn from the U.S. market in 2010 due to increased risks of heart attack and stroke. The product is excluded from the dietary supplement definition because sibutramine was authorized for investigation as a new drug before being marketed as a dietary supplement or food. The product is considered a drug under the FD&C Act due to its intended use for weight loss and body shaping, and it is an unapproved new drug as it lacks FDA approval. Furthermore, it is a prescription drug due to its toxicity and the need for professional supervision.

"Meizi Super Power Fruits" is also misbranded because its labeling is false and misleading regarding safety, failing to disclose the presence of sibutramine and its associated health risks. It lacks adequate warnings and is dangerous when used as recommended.

The FDA also noted that the company offers "Trim-Fast Slimming Soft Gel," "Fruta Bio," "Meizitang Strong Version," "2 Day Diet," and "Super Slim," which have previously been found to