iSlim, LLC – FDA Warning Letter, May 16, 2023
The FDA issued a Warning Letter to Mr. Shans on May 3, 2023, following a December 2022 review of www.alfia.com, where "Alfia Weight Loss Capsules" were sold. Laboratory analysis confirmed the product contains undeclared sibutramine, a drug withdrawn from the U.S. market in 2010 due to increased risks of heart attack and stroke.
The product is deemed an unapproved new drug under sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)) because it is intended to affect body structure/function and is not generally recognized as safe and effective. No FDA-approved application exists for it.
Furthermore, "Alfia Weight Loss Capsules" is a misbranded drug under section 502 of the FD&C Act (21 U.S.C. 352) and violates section 301(a) (21 U.S.C. 331(a)). Specific misbranding violations include: - Failure to bear adequate directions for use (502(f)(1)), as sibutramine requires professional supervision and was withdrawn due to safety risks. - False or misleading labeling (502(a)) due to the undeclared
ID · 3a746a5d-a7ec-43da-bfe5-70aaf59ccacd
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