What happened
Original notice title
Golean Detox US MARCS-CMS 573404, April 29, 2019
From the archived source record
Food and Drug Administration (FDA) has reviewed the information on your Facebook page, [see original source] / , and determined that you offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, FDA has determined that the “Golean Detox” product you offer for sale is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the FD&C Act [21 U.S.C. §§ 355(a) and 331(d)]. Furthermore, this product is a misbranded drug sold in violation of sections 502 and 301(a) of the FD&C Act [21 U.S.C. §§ 352 and 331(a)]. FDA confirmed through laboratory analysis that your “Golean Detox” contains undeclared sibutramine and phenolphthalein. Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke. Studies have indicated that it presents a cancer-causing risk. FDA has issued a warning to consumers not to use “Golean Detox” (see GoLean Detox Immediate Public Notification). Unapproved New Drugs You market “Golean Detox” as a dietary supplement. Labeling statements documenting the intended uses include, but are not limited to, the following: Product Label: · “Enhanced metabolic support excessive fat, help lose weight, reduce the risk of obesity” · “…incinerate fat…” · “…lose body fat…” · “…clear excess waste and transport toxins through the digestive system” · “…helps suppress hunger, increase blood flow and even improves your immune system. Misbranded Drugs Your “Golean Detox” product is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] in that the labeling for this drug fails to bear adequate directions for use.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- d6d539aa6452
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →