Yes, VASCEPA can be changed from an FDA approved drug to an OTC food product. You might recall several back and forth conversations between BioBillionare (RIP), and Janet Woodcock ( Former Acting FDA Commissioner) regarding that idea.
However, considering our current momentum in Europe and ROW we would not like to risk what we have established there. VASCEPA’s specific formulation distinguishes itself from the unregulated and potentially harmful OMG-3 food supplements. It’s been a long road for IPE, but its recognition as a safe and effective CVD reducing drug is finally getting attention.