Sabinsa Corporation has filed substantive comments with the FDA in support of the Citizen Petition filed by OVOS Natural Health, Inc. Seeking Promulgation of a Regulation Pursuant to § 201(ff)(3)(B)(ii). Under the Federal Food, Drug, and Cosmetic Act as amended by DSHEA, such authorization is required prior to marketing an ingredient that has been the subject of such an in-depth scientific investigation. The company is requesting that FDA implement this section of the law for the first time.
"As a company that invests heavily in science to back its products, we strongly believe that FDA needs to implement all parts of DSHEA including those portions of the law that ensure that companies engaging in serious scientific research can get their products onto the market," said Sabinsa CEO Jeff Lind.
OVOS parent company Bellus Health, Inc. previously held the Investigational New Drug Application (“IND”) under which the amino acid Homotaurine was authorized for study. BELLUS conducted a 78-week trial in which Homotaurine was studied for potential pharmaceutical applications. OVOS’ Citizen Petition notes that although these studies established the safety of this ingredient and the potential health benefits of its use, BELLUS concluded that 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.
"FDA should support companies that invest in science and IP, the way DSHEA intended FDA to" stated industry regulatory attorney Marc Ullman, who filed the petition on behalf of OVOS.