NAI self-affirms GRAS for sustained release CarnoSyn, builds IP

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© iStock/s-c-s

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The Generally Recognized as Safe (GRAS) status of Natural Alternatives International’s sustained release beta-alanine (SR CarnoSyn) has been affirmed by a panel of independent experts.

The self-affirmation allows NAI to broaden its product offerings beyond the sports nutrition space and focus on the food and beverage industries including medical and other fortified food products.

Mark Le Doux, chairman and CEO of NAI, stated, "We are very pleased with the results of the safety evaluation of SR CarnoSyn by a panel of independent experts.  Over the last several years, NAI has made strategic investments in the areas of research and development, intellectual property, regulatory and commercialization surrounding our plans for current and future SR CarnoSyn product offerings. 

“The fact that the panel has finalized its scientific analysis and concluded that 12 grams of SR CarnoSyn, which contains 7 grams of active CarnoSyn beta-alanine, was well tolerated in human clinical trials, confirms our belief such dosage amounts are safe and effective.  Satisfying these critical elements of GRAS determination allows us to continue to pursue several avenues for SR CarnoSyn and collaborate with key partners in some of the fastest growing industries."


The company also announced that it has received a Notice of Allowance of a patent application directed to a broad range of improved methods of beta-alanine intake from the US Patent and Trademark Office.

These 28 allowed patent claims target such benefits as delaying muscle fatigue, increasing anaerobic capacity, increasing muscle strength and increasing muscle endurance, said the company in a press release.

This also significantly lengthens the patent coverage around its original CarnoSyn beta-alanine to 2023.

“NAI is very excited by the addition of this important intellectual property related to a broad range of improved methods of beta-alanine intake,” ​said Le Doux. “We believe this new patent continues to strengthen our worldwide portfolio of intellectual property related to our branded CarnoSyn beta-alanine.  Moreover, these patent rights will not expire until 2023, which gives NAI and its dedicated licensees the benefit of offering products that include CarnoSyn beta-alanine and the patent portfolio surrounding it.  These new patent rights further demonstrate our commitment and significant investment in the CarnoSyn beta-alanine business.”

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