PURCHASE, NEW YORK – October 2, 2014 – “Nutrition 21, LLC announced today that the company’s newest sports nutrition product, Nitrosigine®bonded arginine silicate, is now GRAS (Generally Recognized As Safe) affirmed at the level of 1,500 mg per day for use in nutritional bars and beverages. An independent panel of experts approved this level of Nitrosigine® as GRAS after careful review of an extensive dossier of safety data that was compiled by Intertek, a pre-eminent science and regulatory consultant group.

“This newly affirmed GRAS status now enables functional beverage and nutritional bar manufacturers to utilize Nitrosigine® and all of its clinically supported claims. Nitrosigine® is the perfect ingredient to formulate into sports nutrition products to help enhance performance through an entire workout. Fitness-focused consumers who want to get the most out of their training regimen, will appreciate that Nitrosigine® is quickly absorbed by the body, taking effect in 30 minutes and lasting up to three hours,” stated Bill Levi Nutrition 21, LLC, Vice President, Strategy & Business Development.

Nitrosigine® has been clinically shown to significantly boost nitric oxide (NO) levels,1 a key factor in increasing blood flow to working muscles. Nitrosigine® has also been shown in clinical and pre-clinical studies to significantly raise arginine and silicon levels – both important nutrients for cardiovascular performance.2  “The benefits seen with Nitrosigine® can also be applied to other categories, including cardiovascular health and men’s health. Nitrosigine® provides the benefits of arginine and silicon, with additional benefits from the unique combination,” said James Komorowski, MS, CNS, Vice President Scientific and Regulatory Affairs at Nutrition 21.

“Consumer demand continues to rise for truly functional food and beverage products. However, food companies have indicated that their product development options are limited by the scarcity of functional ingredients that are GRAS at levels supported by clinical study outcomes. Nitrosigine®, with its GRAS affirmation at clinically meaningful doses and substantiated health benefits, is perfectly suited to address both consumer and food industry needs,” Bill Levi Nutrition 21, LLC, Vice President, Strategy & Business Development stated.

About Nitrosigine®

Nitrosigine®, an FDA accepted New Dietary Ingredient (NDI), is for use in sports nutrition workout products.  Nitrosigine® is a patented complex that bonds arginine and silicate, scientifically engineered to deliver benefits to consumers engaged in fitness training programs. Manufactured in the U.S., Nitrosigine® is a safe, non-stimulant ingredient that is easy to formulate into new and existing sports nutrition products.

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About Nutrition 21, LLC

Nutrition 21, a wholly owned subsidiary of JDS Therapeutics, is a leader in the nutritional supplement industry. The Company is a developer and marketer of efficacious, high-value, clinically substantiated ingredients for dietary supplements, medical foods and beverages, including Chromax®chromium picolinate and Nitrosigine® bonded arginine silicate. In 2013 Nitrosigine® was accepted by the FDA as a New Dietary Ingredient (NDI).

With many years of biotechnology and pharmaceutical experience, the Company’s scientific platform has created unique, patentable products that are safe and clinically effective. Rigorous preclinical and clinical trials are a key part of its product development strategy to ensure product safety and consumer trust.

Nutrition 21 currently holds over 100 domestic and international issued and pending patents for products. Many support unique claims associated with, among others, glucose metabolism, weight management, brain health, cardiovascular health, and sports nutrition.

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Contact Information:

Bill Levi
Nutrition 21, LLC
Vice President, Strategy and Business Development
914 701-4549

James Komorowski, MS, CNS
Nutrition 21 LLC
Vice President, Scientific & Regulatory Affairs
© 2014 Nutrition 21, LLC Nitrosigine® is a registered trademark of Nutrition 21, LLC
1. Kalman D, Feldman S, Samson A, Krieger D. A clinical evaluation to determine the safety, pharmacokinetics and pharmacodynamics of an inositol- stabilized arginine silicate dietary supplement in healthy adult males. The FASEB Journal 2014;28(1):SLB418.
2. Proctor SD, et, al., A Novel Complex of Arginine Silicate Improves Micro- and Macrovascular Function and Inhibits Glomerular Sclerosis in Insulin-Resistant, JCR: LA-cp Rats. Diabetology. 2005;48(9):1925-32.