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Unjury Protein and ProCare Health are prominent in the bariatric and medical nutrition channels, offering easily digestible powders and ready-to-drink solutions tailored to reduced caloric intake and malabsorption challenges
FDA staff's own briefing document, posted publicly ahead of the meeting as part of the docket, proposes that TB-500 (free base) and TB-500 acetate not be added to the list, citing incomplete physicochemical characterization, a lack of evidence of effectiveness for wound healing (including an in-vitro fibroblast study in which TB-500 reportedly did not induce wound healing), and insufficient nonclinical and clinical safety data
Studies have shown L-theanine crosses the blood-brain barrier intact and can continue to balance neurochemistry by blocking glutamate transport, reducing levels of extracellular glutamate and supporting the release of dopamine and glycine from neurons
