Homotaurine
The chemical structure may be simple, but there was nothing simple about FDA's "hyper-technical" seven-page document detailing why homotaurine (structure above) is not an amino acid and did not fit any other dietary ingredient category as listed under section 201(ff)(1) of the Food, Drugs and Cosmetics Act (FDCA).
As February drew to a close, the Food and Drug Administration (FDA) rejected Canadian biotech firm Ovos’s bid to win NDI status for its homotaurine brain health ingredient because the agency said the nutrient found in certain seaweeds is not an amino acid.
FDA said that for the purposes of that section of the FDCA, “the term ‘amino acid’ refers to an alpha-amino carboxylic acid used as a constituent of proteins or peptides. Homotaurine is a gamma-amino sulfonic acid. It is not an alpha-amino carboxylic acid or a constituent of proteins.”
To read our coverage of the decision, please click here. To read the response of Marc Ullman, the attorney who lodged the petition on behalf of Ovos, please click here.