Self-Affirmed GRAS status for glucosamine joint health product

The company’s Larry Kolb, president, US Operations, told NutraIngredientsUSA.com: “This affirmation is especially valuable to those customers who are using glucosamine in liquid dietary supplements. The FDA​ (Food and Drugs Administration) has tremendous momentum to regulate liquid dietary supplements as foods.”​

Valuable market protection​

“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​,” he added.

The product, comprising premium grade chondroitin sulfate and glucosamine, delivers consistent, superior quality ingredients for joint health products, claims the company.

This self-affirmed GRAS status has been in development for more than one year while Pureflex glucosamines have been on global sale for over 10 years.

Glucosamines are needed to make body cartilage. Manufactured in the body from glucose and an amine, its main role in the joints where it stimulates manufacture of glycosaminoglycan which is a main structural component of cartilage.

“TSI is the first and only manufacturer/supplier in the US to offer GRAS-certified glucosamine that is derived from shellfish​,” said Kolb. No more information was available about the type of shellfish involved.

The GRAS affirmation was conducted by a panel of independent experts. It concluded Pureflex Glucosamine Hydrochloride, Pureflex Glucosamine Sulfate Sodium and Pureflex Glucosamine Sulfate Potassium, produced by TSI, are safe when added in conventional foods and beverages.

Food-grade specifications​

The panel based their analysis on food-grade specifications with respect to production and purification processes required to produce food-grade material plus clinical studies on human allergen testing and other safety studies.

The company estimates the value of the retail market for glucosamine-containing foods to be several hundred million dollars per year.

Meanwhile, the company says it is in the final process of achieving the same GRAS self-affirmation for its product Pureflex Chondroitin Sulfate.