Hua Da Trading, Inc.
FDA issued a warning letter to Hua Da Trading, Inc. (Brooklyn, NY) regarding its 'WeFun' product, which was marketed as a dietary supplement but found via laboratory analysis to contain undeclared sildenafil, a prescription PDE-5 inhibitor. The product was deemed an unapproved new drug and misbranded under the FD&C Act because its labeling lacked adequate directions for use, failed to disclose the active pharmaceutical ingredient, and bore false or misleading claims. FDA warned that failure to address violations could result in seizure and/or injunction, and required a written response within fifteen working days.
Flagged claims (3)
WeFun Natural Male Energy Supplement, Amplifier for Strength, Performance, Energy, and Endurance
ENERGY
PERFORMANCE
Required actions (2)
Please submit a written response to this letter within fifteen working days from the date of receipt, explaining the specific steps you have taken to address any violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.
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