PHOENIX, Aug. 17, 2017 — ThermoLife International, LLC, a world leader in nitrate technology with a global portfolio of 27 patents that includes more than 450 valid and issued claims relating to the use of nitrates in dietary supplements, has announced its successful submission of a New Dietary Ingredient Notification (NDIN) for Creatine nitrate (CreN) with the FDA.
ThermoLife’s patented CreN is licensed by some of the most reputable and successful sports nutrition companies in the world including Nutrabolt, a globally recognized leader in sports nutrition whose brand portfolio includes the award winning Cellucor® brand of dietary supplements. Invented by ThermoLife, CreN is a highly soluble and advanced form of creatine that delivers the dual functionality benefits of creatine and dietary nitrates. ThermoLife developed CreN and its other amino acid nitrate ingredients to offer consumers the health and performance benefits of nitrates while at the same time improving upon the physiological properties of creatine and other amino acids. These improvements include vast enhancements in solubility, stability, and dissolution.
Ron Kramer, the President and CEO of ThermoLife said, “ThermoLife’s patented CreN is prominently featured in some of the world’s best-selling and most effective dietary supplements including Cellucor’s C4–the uncontested industry leader in pre-workout supplementation–and the soon to be released Muscle Beach Nutrition brand of Sports Nutrition Products.”
On April 28, 2017, ThermoLife received a letter from the FDA acknowledging receipt of its NDIN for CreN without objection. Although ThermoLife has long contended that CreN is exempt from the NDIN process, this notification and acknowledgment further supports the self-affirmed GRAS status that ThermoLife has relied upon to market CreN as a safe and compliant dietary ingredient.
Daniel Fabricant, Ph.D., the President and CEO of the Natural Products Association (NPA) and the former Director of the Division of Dietary Supplement Programs at the FDA, said, “The NDI notification process is an important part of the regulatory system and we’ve always encouraged all of our member companies to submit NDINs, even if they believe their NDI is exempt. I applaud ThermoLife, a NPA member, for working with the agency and submitting a notification for CreN consistent with the statute and regulations.”
Prominent food and drug law attorney, A. Wes Siegner, Jr., a partner at Hyman, Phelps & McNamara, P.C. said, “The Federal Food, Drug, and Cosmetic Act has strict standards for the safety of dietary ingredients in dietary supplements, as well as for the safety of ingredients in conventional foods. CreN has been assessed by food safety experts and determined to be safe under both the dietary supplement and conventional food standards. In addition, the dissociation products of CreN, creatine and nitrate, have a long history of safe use in both dietary supplements and conventional foods. FDA has been notified as to the scientific basis for safety of CreN as a dietary ingredient, and has acknowledged ThermoLife’s notification. Therefore, under federal law, any company that has licensed CreN from ThermoLife may legally market CreN in any dietary supplement. Marketing the ingredient is compliant regardless of the amount or dose of CreN in the dietary supplement, as long as the company has a scientific basis to support the safety of the dose that is recommended.”
Nutrabolt has conducted several human clinical studies on CreN and products containing CreN, in a variety of dosages and dosage forms. The studies were conducted at the prestigious Texas A&M University and demonstrated the efficacy, safety and performance benefits of the ingredient.
About ThermoLife International, LLC
Founded in 1998, ThermoLife is a world leader in patented ingredients and technology for use in dietary supplements, specializing in nitrate technology. ThermoLife has a global patent portfolio of 27 patents spanning more than 15 countries including more than 450 valid and issued claims on the use of nitrates in dietary supplements. ThermoLife collaborates with leading manufacturers in the sports nutrition and supplement industry to provide support, innovation, and only the purest, most effective, and innovative ingredients in order to help its customers offer superior patent protected products to end users.
Nutrabolt is a global nutritional life sciences company established in 2002 that specializes in consumer product solutions in sports nutrition and functional foods. The Company’s marquee brands, Cellucor® and Scivation®, include some of the industry’s most notable product lines C4® and Xtend®, which have become uncontested category leaders in pre-workout and intra/post-workout recovery supplementation respectively. Nutrabolt entered the functional food category in 2016 through its FitJoy® branded line of healthy on-the-go protein based snacks. Nutrabolt’s brands are distributed to some of the world’s largest specialty, big box and online retailers including GNC, Vitamin Shoppe, Amazon.com, Bodybuilding.com, Walmart, Costco, and Target. Nutrabolt’s brands are sold in more than 75 countries through its network of global distributors.
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SOURCE ThermoLife International, LLC