ChromaDex, Inc. Release: U.S. FDA Issues GRAS No Objection Letter For NIAGEN
IRVINE, Calif., Aug. 15, 2016 (GLOBE NEWSWIRE) -- ChromaDex Corp. (NASDAQ:CDXC), an innovator of proprietary health, wellness and nutritional ingredients that creates science-based solutions to dietary supplement, food and beverage, skin care, sports nutrition, and pharmaceutical products, announced today that the U.S. Food and Drug Administration (FDA) has issued a generally recognized as safe (GRAS) No Objection Letter, in response to the NIAGEN® nicotinamide riboside chloride (NR) GRAS filing, Notice No. GRN 000635.
Receipt of this No Objection Letter confirms that the FDA has no additional questions regarding this status. The GRAS status compliments the New Dietary Ingredient status already received for NIAGEN®.
NIAGEN® is already available in various supplements online and on select store shelves, but GRAS status defines it as a safe ingredient to use in food and beverage applications such as powdered beverages, protein shakes, nutrition bars, gum and chews. ChromaDex CEO and cofounder, Frank Jaksch Jr., commented, “We have been actively working with a number of manufacturers on early stage development projects to drive the commercialization of NIAGEN® into food and beverage products. The scientific research continues to validate the fact that NR is the most effective and efficient vitamin B3 at boosting NAD+, which increases cellular energy production and supports cellular health. This comes at a time when consumers are more interested than ever in finding products that will help them live longer and healthier throughout their lifetime.”
About the NAD+ booster, Nicotinamide Riboside (NR):
Sometimes referred to as “The forgotten B3," the benefits of NR remained unknown for years after its initial discovery and classification as a vitamin B3, due to the lack of advanced understanding of nucleotide science. It was not until 2004 that this hidden gem resurfaced after Dr. Charles Brenner, then professor at Dartmouth, identified the missing link as to how NR becomes NAD+. This discovery also suggested that NR also had the ability to boost NAD+ in a more energy efficient way than could be achieved with its B3 cousins, niacin or nicotinamide, leaving the body extra energy to focus on its critical needs and processes. NR’s unique energy sparing ability to produce NAD+ has excited the scientific community around the world. This excitement has led to 70 material transfer agreements to top research institutions studying the effects of NR on numerous therapeutic endpoints. The body of evidence continues to build as researchers make seminal discoveries characterizing the potential role of NR on a wide range of health benefits, including increased mitochondrial health resulting in improved cellular energy production, increased muscle endurance, neuroprotection, improvements in longevity, protection against weight gain when consuming a high fat diet, protection against oxidative stress and improvement of blood glucose and insulin sensitivity. NIAGEN® is the world’s first and only, nature identical form of NR commercially available today.
ChromaDex leverages its complementary business units to discover, acquire, develop and commercialize patented and proprietary ingredient technologies that address the dietary supplement, food, beverage, skin care and pharmaceutical markets. In addition to our ingredient technologies unit, we also have business units focused on natural product fine chemicals (known as "phytochemicals"), chemistry and analytical testing services, and product regulatory and safety consulting (known as Spherix Consulting). As a result of our relationships with leading universities and research institutions, we are able to discover and license early stage, IP-backed ingredient technologies. We then utilize our in-house chemistry, regulatory and safety consulting business units to develop commercially viable ingredients. Our ingredient portfolio is backed with clinical and scientific research, as well as extensive IP protection. Our portfolio of patented ingredient technologies includes NIAGEN® nicotinamide riboside; pTeroPure® pterostilbene; PURENERGY®, a caffeine-pTeroPure® co-crystal; IMMULINA™, a spirulina extract; and AnthOrigin™, anthocyanins derived from a domestically-produced, water-extracted purple corn. To learn more about ChromaDex, please visit www.ChromaDex.com.
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, including statements related to the future commercialization of NIAGEN® into food and beverage products and the effectiveness of NR at boosting cellular energy production and supporting cellular health. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects", "anticipates", "intends", "estimates", "plans", "potential", "possible", "probable", "believes", "seeks", "may", "will", "should", "could" or the negative of such terms or other similar expressions. More detailed information about ChromaDex and the risk factors that may affect the realization of forward-looking statements is set forth in ChromaDex's Annual Report on Form 10-K for the fiscal year ended January 2, 2016, ChromaDex's Quarterly Reports on Form 10-Q and other filings submitted by ChromaDex to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.