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UK consumers should be aware that supplement companies can make structure-function claims without proving they work, unlike prescription medications, which require extensive clinical trials

Breuninger H, Eigentler T, Bootz F, et al

(2008) Mitochondrial Disease in Autism Spectrum Disorder Patients: A Cohort Analysis

However, the authors observed higher rates of hypoglycemia, ketoacidosis, and gastrointestinal adverse events

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(Since initial publication, one of these three companies, BSO LLC, which was making sterile pellets was inspected June 27th, 2025, and received a Form 483 in follow up.) Ultimately, the lack of inspections for registered 503B facilities puts patients at risk