Loading…
HIS Enterprise Inc dba Adam's Secret USA, LLC sold unapproved new drugs and misbranded products in violation of the Federal Food, Drug, and Cosmetic Act through their website and social media platforms. FDA laboratory analysis confirmed that multiple Adam's Secret product variants and Dr. Reade Slim Sense contained undeclared pharmaceutical ingredients—specifically tadalafil and/or sildenafil, which are prescription-strength phosphodiesterase type-5 inhibitors—without FDA approval or proper labeling. The company marketed these products directly to consumers online without the required new drug applications, and failed to disclose the presence of active pharmaceutical ingredients in their products.