What happened
Original notice title
Genesis Nutrition Ultra Slim dba Genesis Ultra Slim MARCS-CMS 616040, August 06, 2021
From the archived source record
Therefore, this product is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d), and a misbranded drug sold in violation of sections 502 and 301(a) of the FD&C Act, 21 U.S.C. 502 and 331(a). FDA confirmed through laboratory analysis that a sample of your "Genesis Ultra Slim Gold" 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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke.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 "Genesis Ultra Slim Gold" (see Genesis Ultra Slim Gold Immediate Public Notification). Unapproved New Drug You market "Genesis Ultra Slim Gold" as a dietary supplement. Misbranded Drug Your “Genesis Ultra Slim Gold” 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. It is impossible to write “adequate directions for use” for "Genesis Ultra Slim Gold" for at least two reasons: 1) prior to withdrawal of Meridia’s approval, FDA approval of sibutramine was limited to use under the professional supervision of a practitioner licensed by law to administer such drugs and 2) FDA approval of Meridia was withdrawn because of serious safety risks. As such, the labeling of "Genesis Ultra Slim Gold" fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the FD&C Act.
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
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 065e74533b5e
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.
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