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Gut surgery, pancreatic insufficiency, small intestinal bacterial overgrowth (SIBO), parasite infections, and certain autoimmune disorders are considered additional risk factors

At present: There is no FDA approval There is no standard prescription pathway There is no approved supplement classification There is no lawful retail medical distribution model The only compliant framework that exists today is legitimate research distribution , meaning: Supplied for scientific investigation Not sold as treatment Not administered to patients Not marketed for healing or recovery Anything else blurs into non-compliance