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Hua Da Trading, Inc. was warned for selling "WeFun," an unapproved new drug marketed as a dietary supplement in violation of sections 505(a) and 301(d) of the FD&C Act. FDA laboratory analysis confirmed the product contained undeclared sildenafil, a prescription-only PDE-5 inhibitor that poses serious safety risks including dangerous blood pressure drops when combined with nitrates commonly prescribed to patients with diabetes, heart disease, and high cholesterol. The product was also deemed misbranded because sildenafil was never marketed as a dietary supplement or food before its FDA approval as Viagra in 1998, making it ineligible for dietary supplement classification under section 201(ff)(3)(B)(i) of the FD&C Act.