Nature Biotechnology , 15 (8), 778783
When youre vitamin B12 deficient, it can lead to various symptoms including fatigue, weakness, shortness of breath, heart palpitations, and more
Officially, the FDA cites: Insufficient large-scale clinical trials Concerns about consistency, sourcing, and manufacturing standards The need to meet formal drug approval requirements Critics argue (fairly) that this system: Favors large pharmaceutical companies Makes it hard to approve naturally occurring peptides Leaves promising, low-risk compounds in regulatory limbo The short version: This FDA restrictive regulatory change of mind wasnt driven by a sudden safety scare, it was driven by regulatory process and economics
Potential Side Effects and Limited Human Data While preclinical studies have not shown significant toxicity at standard doses, the research in humans is still in its early stages