Bioactive Peptides in Functional Foods: From Production and Validation to Commercialization, Regulatory Hurdles, and...

Bioactive peptides (BAPs) exhibit a wide range of health-promoting properties, positioning them as key ingredients for the functional food market. This review provides a comprehensive assessment of the BAP landscape, from discovery and production to commercialization and regulation. Conventional and emerging production technologies are critically analyzed, highlighting advancements in enzymatic hydrolysis, microbial fermentation, and physical processing methods like high-pressure and ultrasound-assisted extraction. The multi-tiered validation pipeline, spanning in silico prediction, in vitro screening, and in vivo models, is examined, revealing a significant disconnect between preliminary bioactivity data and demonstrable clinical efficacy, which is a primary cause for regulatory failure. Commercialization is hampered by technical challenges, including poor bioavailability, gastrointestinal instability, and undesirable sensory attributes, which are being addressed by innovative formulation strategies such as nano-encapsulation. A comparative analysis of global regulatory frameworks, particularly the divergent approaches of the US FDA and EU EFSA, underscores the hurdles in substantiating health claims, with a universal demand for rigorous human clinical trials. Finally, the future prospects are explored, identifying critical research gaps and highlighting the transformative potential of AI-driven peptide design and personalized nutrition through nutrigenomics to unlock the full potential of BAPs. The review further links peptide structure to nine major biological activities, critically compares advanced delivery systems and manufacturing scale-up, and extends the regulatory analysis to major Asia-Pacific markets.