FDA WARNING_LETTER - Hua Da Trading, Inc. - December 20, 2023

The FDA issued a Warning Letter to Daniel Zeng regarding the product "WeFun" sold on eshoponlineusa.com. An FDA review from July-December 2023 and laboratory analysis confirmed "WeFun" contains undeclared sildenafil, a PDE-5 inhibitor and active ingredient in the prescription drug Viagra.

This makes "WeFun" an unapproved new drug under sections 505(a) and 301(d) of the FD&C Act, as sildenafil was not marketed as a dietary supplement before Viagra's approval in 1998. The product is also misbranded under section 502 of the FD&C Act and sold in violation of section 301(a). Misbranding violations include failure to bear adequate directions for use (502(f)(1)), false or misleading labeling due to undeclared sildenafil (502(a)), and lack of adequate warnings (502(f)(2)). Sildenafil can dangerously lower blood pressure, especially for individuals on nitrates.

The letter also expresses concern about other products sold on the website, such as "BLACK ANT KING," "BIGGER LONGER," "Germany Black Gorilla," and "Rhino" products, which FDA has previously found to contain undeclared sildenafil and/or tadalafil, and "Royal Honey," previously found to contain undeclared PDE-5 inhibitors.

The company must