Sustain Injection for Men is a procedure which uses one of several FDA approved neuromodulators for the treatment of erectile dysfunction in men. This is considered an “Off Label” use, meaning that the FDA has not yet evaluated the use of the medication for this indication. Physicians are permitted to use medications in Off Label applications when there is good evidence for benefit, regardless of the status of FDA evaluation. This is quite commonplace in medicine in general. Botulinum toxin in particular is a medication with a history of many decades of Off Label use for a wide variety of indications.