What happened
Original notice title
iSlim, LLC MARCS-CMS 655819, May 03, 2023
From the archived source record
As described below, 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 (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your “Alfia Weight Loss Capsules” product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352 and sold in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a). FDA confirmed through laboratory analysis that a sample of your “Alfia Weight Loss Capsules” contains undeclared sibutramine. 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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke. Unapproved New Drug Your “Alfia Weight Loss Capsules” product is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because it is intended to diagnose, cure, mitigate, treat, or prevent disease and/or affect the structure or function of the body. Removes deposited fat” Under the heading, “Mechanism of Action”: “ALFIA helps to digest the food, hasten ALFIA helps to digest the food, hasten the fat metabolism and protect the digest[sic] organs against diseases in advance.” Under the heading, “Loosening bowel to relieve constipation decontaminating circulation system, promoting metabolism”: “The ingredients which include semen cassia seed can loosen [the] bowel to relieve constipation. Misbranded Drug Your “Alfia Weight Loss Capsules” product is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that its labeling fails to bear adequate directions for use. It is impossible to write “adequate directions for use” for “Alfia Weight Loss Capsules” 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professional supervision of a practitioner licensed by law to administer such drugs and 2) FDA approval of Meridia was withdrawn because of serious safety risks.
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
- 4f00be4d9824
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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