FDA WARNING_LETTER - U.S.A Far Ocean Group LLC/Health & Beauty Group Inc.

The FDA issued a Warning Letter to USA Far Ocean Group Inc. and Health & Beauty Group Inc. for marketing and distributing various products in violation of the Federal Food, Drug, and Cosmetic Act.

FDA laboratory analyses confirmed that "U-Prosta," "Male Enhancer," and "X-Hero" contained undeclared active pharmaceutical ingredients (APIs): terazosin, tadalafil, and sulfosildenafil, respectively. These products are deemed unapproved new drugs and misbranded because they contain prescription drug ingredients, lack FDA approval, and fail to bear adequate directions for use or disclose critical safety information. The undeclared APIs pose serious health risks due to potential adverse effects and drug interactions.

Additionally, products like "New Prosta," "New Hero," "Liver Care," "Power Up," "Cardio Care," "Glucose Balance," "Cholesto Care," and "Quick Slim" are marketed with disease treatment claims, classifying them as unapproved new drugs and misbranded due to lacking FDA approval and adequate directions for use.

Furthermore, "Female One," "Vagifresh Ball," "Vagifresh Moisturizing Gel," "Vagifresh Liquid," "Minimizer," and "Spot & Whitening Cream" are also considered unapproved new drugs and misbranded due to therapeutic claims and lack of FDA approval and adequate directions. "Instant Lift" is cited as an unapproved new drug for its structure/function claims.

The FDA acknowledges previous