PISCATAWAY, N.J.— Sabinsa Corp. filed comments with FDA related to a Citizen Petition filed by OVOS Natural Health, seeking promulgation of a regulation related to marketing new dietary ingredients (NDIs) that have been the subject of in-depth scientific investigation. FDA has not implemented the portion of the Dietary Supplement Health and Education Act (DSHEA) related to authorizing companies to market such ingredients.
Bellus Health Inc., the parent company of OVOS, previously held an Investigational New Drug (IND) application on and conducted an extensive study involving the use of the amino acid homotaurine for potential pharmaceutical applications. OVOS’ Citizen Petition notes that although these studies established the safety of this ingredient and its potential health benefits, BELLUS concluded completing the new drug approval process would be economically impracticable and voluntarily discontinued the IND. BELLUS thereafter incorporated OVOS for the purpose of pursuing a path to market for homotaurine as a new dietary ingredient for use in dietary supplements.
Sabinsa’s comments can be accessed on the FDA’s docket here.
