Larry Kolb, president, US operations, TSI Health Sciences, Inc. (TSI) has announced that its PUREFLEX® Glucosamine Salts have obtained self-affirmed GRAS (Generally Regarded As Safe) status for use in conventional foods and beverages.
“TSI is the first and only manufacturer/supplier in the US to offer GRAS-certified Glucosamine that is derived from shellfish,” said Kolb. “There is a tremendous amount of momentum today within FDA to regulate liquid dietary supplements as foods. TSI’s GRAS affirmed PUREFLEX® Glucosamine ingredients will provide our customers with valuable market protection in the event GRAS affirmed Glucosamine ingredients become a requirement for inclusion in liquid products,” Kolb added.
The GRAS affirmation was conducted by a panel of independent experts, which deemed PUREFLEX® Glucosamine Hydrochloride, PUREFLEX® Glucosamine Sulfate Sodium and PUREFLEX® Glucosamine Sulfate Potassium produced by TSI safe when added in conventional foods and beverages. Their independent analysis was based on TSI’s establishment of the appropriate food-grade specifications with respect to production and purification processes required to produce food-grade material as well as on the results of advanced clinical studies on human allergen testing and other safety studies.
PUREFLEX® Glucosamine ingredients are manufactured in a TSI owned and operated cGMP certified manufacturing facility, ensuring that all levels of production are monitored meticulously from start to finish. TSI also houses a sophisticated analytical laboratory in which each lot of Glucosamine is rigorously tested to confirm quality.
For more information about PUREFLEX®visit www.TSIInc.com or call toll-free 877.549.9123.
About TSI Health Sciences
TSI Health Sciences, www.TSIInc.com, is a leading developer, producer and marketer of fine chemical ingredients used by the dietary supplement, pharmaceutical and food and beverage industries. With US operations based in Missoula, Montana, TSI was founded in 1996 and has sales and marketing offices worldwide, including a 60-acre, fully integrated manufacturing, research, quality assurance and quality control campus in Jiangyin, China. The company’s specialized product range includes performance-based branded ingredients that are derived from botanical and natural product extracts, fermentation, and highly purified synthesis. TSI manufactures its ingredients to the strictest global standards, including ICH Q7A international CGMP manufacturing guidelines.