title: Tagatose, the new GRAS sweetener and health product.
abstract: Tagatose, a low-calorie, full-bulk natural sugar, has just attained GRAS (Generally Recognized As Safe) status under U.S. Food and Drug Administration (FDA) regulations, thereby permitting its use as a sweetener in foods and beverages. This paper presents all current aspects of tagatose with respect to demonstrated food and beverage applications and the potential health and medical benefits of this unique substance. Summarized studies are referenced to detailed peer-reviewed papers. The safety studies followed the recommendations in the FDA "Red Book." Results were submitted to an Expert Panel for determination of GRAS status under FDA regulation. Small phase 2 clinical trials showed tagatose to be effective in treating type 2 diabetes. The results, buttressed by the references cited, support the efficacy of the various applications disclosed for tagatose. Tagatose has been found to be safe and efficacious for use as a low-calorie, full-bulk sweetener in a wide variety of foods, beverages, health foods, and dietary supplements. It fills broad, heretofore unmet needs for a low-calorie sweetener in products in which the bulk of sugar is important, such as chocolates, chewing gum, cakes, ice cream, and frosted cereals. Its synergism with high-intensity sweeteners also makes it useful in sodas. Various health and medical benefits are indicated, including the treatment of type 2 diabetes, hyperglycemia, anemia, and hemophilia and the improvement of fetal development.
authors.affiliation: Spherix Incorporated, 12051 Indian Creek Court, Beltsville, MD 20705, USA.
authors.forename: Gilbert V
authors.initials: GV
authors.lastname: Levin
mesh_terms: D003257:Consumer Product Safety; D003920:Diabetes Mellitus / Q000178:diet therapy*; D058870:Food, Organic; D006262:Health; D006601:Hexoses / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D006801:Humans; D007881:Legislation, Food; D012449:Safety; D013549:Sweetening Agents / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D006601:Hexoses; D013549:Sweetening Agents; C030192:tagatose