Who the hell are they selling it to? I still think it's high purity DS EPA - if you download the FDA's DMF list, you'll find vitamins, amino acids, and other things that are clearly not drugs or devices - for instance I found L-ASPARTIC ACID and L-ARGININE, submitted by TANABE SEIYAKU CO LTD in 1968, and those are absolutely DS, not drugs - I've taken both (still take l-arginine). Heck, I even found SACCHARIN - clearly a DS or "food additive".