Health Claim Substantiation Becomes The Category's Real Gatekeeper
European Food Safety Authority review of novel peptide health claims has become the binding constraint on category growth, with dossier preparation now running 18 to 30 months and costing well into seven figures per claim. Suppliers who cleared review for milk-derived antihypertensive peptides in the early 2020s built a defensible marketing position competitors could not copy without repeating the same clinical trials. The FDA's qualified health claim pathway runs on a similarly demanding evidentiary standard. Ingredient houses are now pooling clinical trial costs across consortium structures to spread the expense across multiple applicants filing related dossiers together.
Market Impact: Commands 3x to 8x standard pricing








