Abstract

OSR#1^®, also known as NBMI, is a lipophilic chelator and potent antioxidant. NBMI chelates irreversibly most toxic metals, notably mercury. Mercury is an insidious toxicant whose broad molecular mechanism—binding to sulfur—creates multiple toxic effects that interact to create a biochemical train wreck. The resulting dysregulation of multiple organ systems causes or contributes to most chronic illnesses as well as to aging. As an oxidative-stress remedy, NBMI employs two key mechanisms. 1) It scavenges hydroxyl radicals, three per molecule. 2) By chelating both mercury (Hg²⁺) and free iron (Fe²⁺), NBMI prevents the Fenton reaction and its resulting cascade of oxidative stress. As a result, NBMI boosts levels of reduced glutathione, the body’s main intracellular antioxidant, and also improves the ratio of reduced to oxidized glutathione. Since 2010, NBMI’s developer has been pursuing drug approval before the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and recently the regulatory body, INVIMA, in Columbia, South America.

In 2008, following a decade of effort, retired chemistry professor Boyd Haley, PhD, introduced OSR#1^® (Oxidative Stress Relief) as a doctor-dispensed, antioxidant dietary supplement, under pharmacovigilance. The compound is made from two natural, dietary ingredients—dicarboxyl benzoate and cysteamine, found in cranberries and meat, respectively—thus meeting the criteria of the US Food and Drug Administration (FDA) for dietary supplements in effect at that time (i.e., any natural ingredient or combination of two, without claims of treating a disease). But in 2010, after multiple blog claims by physicians and parents of autistic children that OSR#1^® alleviates many symptoms of autism, the FDA changed its dietary-supplement rule specifically to exclude OSR#1^®. Thus, despite consumer accolades and no evidence of harm, Haley was forced to cease and desist all sales. Haley’s dismayed dentist and physician clients urged him to seek formal drug approval, and nearly one hundred of them offered early financial support for the lengthy and expensive undertaking.