ChromaDex Lead Ingredient NIAGEN® Nicotinamide Riboside Achieves GRAS Status
- NIAGEN® Also Recently Received New Dietary Ingredient (NDI) Status From the FDA -
IRVINE, Calif., Jan. 04, 2016 (GLOBE NEWSWIRE) -- ChromaDex Corp. (OTCQX:CDXC), an innovator of proprietary health, wellness and nutritional ingredients that creates science-based solutions for dietary supplement, food and beverage, skin care, sports nutrition, and pharmaceutical products, announced today that an independent scientific panel of experts determined that NIAGEN®, ChromaDex’s patented and proprietary lead ingredient, is Generally Recognized As Safe (GRAS).
By achieving GRAS status, ChromaDex can now expand NIAGEN® into the food and beverage industry, moving beyond the supplement industry where it has been increasingly incorporated into numerous finished consumer products.
Following a critical review of the comprehensive safety information and the estimated intake from its proposed uses, an independent panel of experts reached a unanimous decision that NIAGEN® is safe for use in food. An ingredient can be determined to be GRAS for use in foods through scientific procedures if it is generally recognized among qualified experts, as described under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act, and FDA's implementing regulations in 21 CFR 170.3 and 21 CFR 170.30, that it has been adequately shown to be safe under the conditions of its intended use. The standard is rigorous; a GRAS ingredient requires documentation of the same quantity and quality of scientific evidence as is required to obtain approval of the substance as a food additive.
Frank Jaksch Jr., founder and CEO of ChromaDex, commented, “Receiving GRAS status immediately allows NIAGEN® to be included as an ingredient in both food and beverages –applications that we believe presents a very substantial opportunity for ChromaDex. Coupled with the recent NDI status, we believe the stage is set for widespread commercialization of NIAGEN® as an innovative and compelling ingredient across a myriad of consumer products.”
The GRAS status for NIAGEN® follows ChromaDex’s announcement last month that the New Dietary Ingredient Notification (NDIN) for NIAGEN® was successfully filed and ChromaDex received a letter of acknowledgement without objection from FDA.
In August 2015, ChromaDex announced results from the first human clinical study which demonstrated that a single dose of NIAGEN® can elevate the co-enzyme NAD+ in the blood by as much as 2.7-fold and was safe.
ChromaDex's NIAGEN® is the first and only commercially available form of nicotinamide riboside (NR) and is supported by five patents issued and several pending, with patents rights acquired from Dartmouth College, Cornell University and Washington University.
Published research has shown that NR is perhaps the most effective precursor to boost the co-enzyme NAD+ in the cell. NAD+ is arguably the most important cellular co-factor for improvement of mitochondrial performance and energy. In recent years, NAD+ has been shown to be essential in supporting healthy cellular metabolism including the efficient conversion of blood glucose into energy.
As organisms age, NAD+ levels drop, which leads to a decrease in mitochondrial health; this in turn leads to age-related health issues. Low NAD+ levels limit activity of a group of enzymes called sirtuins, which are believed to play a key role in longevity. NAD+ levels also can be depleted by lifestyle choices such as overeating and lack of exercise. By boosting NAD+, NR can increase mitochondrial health and induce creation of new mitochondria.
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; ProC3G®, a natural black rice containing cyanidin-3-glucoside; IMMULINA™, a spirulina extract; and Suntava® Purple Corn derived from a proprietary non-GMO purple corn hybrid which contains an extraordinarily high level of anthocyanins. 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. 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. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in ChromaDex's business. 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 3, 2015, ChromaDex's Quarter 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. 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.
Statements in this press release have not been evaluated by the Food and Drug Administration. Products or ingredients are not intended to diagnose, treat, cure or prevent any disease.
ChromaDex Company Contact: Andrew Johnson, Director of Investor Relations 949-419-0288 firstname.lastname@example.org ChromaDex Investor Contacts: The Del Mar Consulting Group, Inc. Robert B. Prag, President 858-794-9500 email@example.com