What happened
Original notice title
Distributor RFR, LLC MARCS-CMS 643724, January 09, 2023
From the archived source record
Based on the inspection and review of your product labeling, including your firm’s website, FDA determined that “SANGTER Energy Supplement” 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, the 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 product, “SANGTER Energy Supplement,” contains the undeclared active pharmaceutical ingredient (API), sildenafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor. Sildenafil is the active pharmaceutical ingredient in Viagra, an FDA-approved prescription drug used to treat erectile dysfunction (ED). 1 Information on the labels and/or labeling of “SANGTER Energy Supplement” demonstrates that the sampled product is marketed as a dietary supplement. Unapproved New Drug “SANGTER Energy Supplement” 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 for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Misbranded Drug “SANGTER Energy Supplement” is also misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that the labeling fails to bear adequate directions for its intended use(s). “SANGTER Energy Supplement,” which contains undeclared sildenafil, is also a prescription drug as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), in light of its toxicity or potential for harmful effects, methods of use, or collateral measures necessary for its use. For these reasons, “SANGTER Energy Supplement” is 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
- 85c4ce5744e8
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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