FDA WARNING_LETTER - Golean Detox US - April 29, 2019

The FDA issued a Warning Letter to GoLean Detox US, owned by Anh Thu Nguyen, on April 29, 2019, following a review of their Facebook page. The letter states that the "Golean Detox" product is an unapproved new drug and a misbranded drug, violating sections 505(a), 301(d), 502, and 301(a) of the FD&C Act.

Laboratory analysis confirmed "Golean Detox" contains undeclared sibutramine and phenolphthalein. Sibutramine, an active pharmaceutical ingredient in the withdrawn drug Meridia, poses risks of heart attack and stroke. Phenolphthalein is not an approved drug ingredient and is a potential carcinogen. The FDA had previously issued a public warning against using "Golean Detox."

The product is deemed an unapproved new drug because sibutramine was authorized for investigation as a new drug before being marketed as a dietary supplement or food, thus excluding "Golean Detox" from the dietary supplement definition. The product's labeling claims, such as "Enhanced metabolic support excessive fat, help lose weight, reduce the risk of obesity," classify it as a drug. As a new drug, it requires an FDA-approved application, which GoLean Detox US lacks.

"Golean Detox" is also misbranded because its labeling lacks adequate directions for use, which is impossible to provide due to sib