Distributor RFR, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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.

Passage 2

“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.

Passage 3

“SANGTER Energy Supplement” is not generally recognized as safe and effective for its above referenced uses and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).

Passage 4

“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).

Passage 5

Additionally, “SANGTER Energy Supplement” is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).

Passage 6

The undeclared sildenafil in “SANGTER Energy Supplement” also causes the product to be misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because the labeling lacks adequate warning for the protection of users.