Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1“While the little blue pill costs $90/dose at some pharmacies, we offer Cake Meds, which has the exact same active ingredients as the branded variety for less.”
Passage 2“Cake ED Meds are compounded medication with high concentrations of Sildenafil (commonly known as ‘Viagra’) and Tadalafil (commonly known as ‘Cialis’). The two ingredients are combined into one unique compounded medication....”
Passage 3Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.