ChromaDex has filed a petition with the FDA claiming that Elysium's new formulation for Basis contains counterfeit Nicotinamide Riboside (NR) adulterated with the toxic industrial solvent Toluene.
ChromaDex has asked that the FDA declare that the new formulation of Basis is illegally adulterated, block its distribution, seize Elysium's inventory, and enjoin Elysium's supply chain from continuing to manufacture it.
You can read the petition online here (it's a public document):
And a copy is attached here.
The argument in the petition is pretty straight-forward:
ChromaDex filed a New Dietary Ingredient Notification (NDIN) with the FDA, and obtained a GRAS determination from the FDA.
The NDIN defined the identity of, and manufacturing process for, commercial NR, including detailed technical and manufacturing information defining the purity, impurities, residual solvents, and contaminants that may be present within defined limits.
However, a detailed lab analysis of Elysium's new Basis formulation shows that although the new Basis retains the same quantities of NR and Pterostilbene, there are other differences in the structure of the chemicals that show that the new Basis has been created by a different process than the one that was disclosed in the ChromaDex NDIN and that resulted in a GRAS certification.
The new process resulted in the new presence of reportable amounts of heavy metals, including lead, and trace amounts of other toxins. Most important, the lab analysis showed non-trace quantities of the toxic industrial solvent Toluene, ranging from 96-144 mg/kg. The FDA has not set any allowed level of exposure to toluene through oral ingestion of a dietary supplement.
Here are some longer excerpts from the petition:
"ChromaDex is the only supplier of nicotinamide riboside chloride, called NIAGEN®, sold under a New Dietary Ingredient Notification filed with the FDA and has been generally recognized as safe ("GRAS")...
"Elysium's new Basis product is contaminated with toluene (CAS No. 108-88-3), an industrial solvent used in such things as paint thinners, fingernail polish, lacquers, and adhesives. In addition, Elysium is now using a nicotinamide riboside chloride ingredient in its product for which no New Dietary Ingredient Notification has been filed with the FDA and which does not have GRAS status.
"As such, Elysium's Basis product should be found to be adulterated and the FDA should take prompt remedial action to protect public health and safety.
"Action Requested
"ChromaDex specifically requests the following actions take place:
1. Make a determination that Elysium's Basis product is adulterated under 21 U.S.C. § 342(a) and (f) based on the undeclared presence of toluene in the product at a level of 96-144 mg/kg and to take all appropriate remedial action, including that Elysium cease distribution of its Basis product and take other appropriate enforcement action, including seizure of violating products and an injunction against the manufacturers and distributors under 21 U.S.C. §§ 332 and 334.
2. Make a determination that Elysium's Basis product contains a new dietary ingredient under 21 U.S.C. § 350b and that Elysium has not submitted a NDI notification for the NR ingredient in its new Basis product, thereby rendering the product adulterated under 21 U.S.C. § 342(f)(1)(B). As such, Basis should be found to be adulterated under §§ 342(f)(1)(B) and 350b(a), and FDA should take all appropriate remedial action, including that Elysium cease distribution of its Basis product and take other appropriate enforcement action, including seizure of violating products and an injunction against the manufacturers and distributors under 21 U.S.C. §§ 332 and 334.
"NIAGEN® was generally recognized as safe by an independent panel of expert toxicologists, and in August 2016, the FDA issued a GRAS No Objection Letter. In addition, on August 20, 2015, ChromaDex submitted a New Dietary Ingredient Notification ("NDIN") to FDA covering its NIAGEN® product. The NDIN documentation included detailed technical and manufacturing information defining the purity, impurities, residual solvents, and contaminants that may be present within defined limits for commercial NR under the brand name NIAGEN®.
"On November 3, 2015, FDA notified ChromaDex of acceptance of the NDIN for NIAGEN® in accordance with 21 C.F.R. § 190.6 (c). This regulatory procedure established that ChromaDex has defined the identity of, and manufacturing process for, commercial NR.
"NIAGEN® is manufactured by the method described in NDIN 882. The NR product conforming to its specifications was subject to a comprehensive toxicology program that included genotoxicity and mutagenicity studies, acute toxicity, a 14-day dose range finding study, subchronic toxicity (90-day rodent study), and a human study. These studies were conducted in accordance with good laboratory practices (GLP) and preclinical studies following accepted OECD protocols. ChromaDex employs a comprehensive quality assurance program that is intended to ensure that its commercially available nicotinamide riboside conforms to the specifications defined in NDIN 882, thereby assuring that all product released into commerce is safe for intended use.
"The residual solvents analysis indicated the presence of four solvents in the August samples that are not found in the July samples. The solvents detected in the August samples
include ethanol, ethyl acetate, dichloromethane (DCM), and toluene. While ethanol, ethyl acetate and DCM were present in trace concentrations, toluene was present at 96-144 mg/kg, which renders Elysium's product adulterated...Lead, molybdenum, and zinc were not detected in the July samples but were detected in the August samples.
"The compositional differences in the product point to a different source of NR that was not supplied by ChromaDex in the samples received in August. The impurity differences, solvents present, metals composition and NMR spectra all support the conclusion that a new source of NR must be present in the formulation currently being sold by Elysium. Elysium's new source of ingredients is currently unknown to ChromaDex.
"FDA has not set any allowed level of exposure to toluene through oral ingestion of a dietary supplement. Toluene is not listed as a solvent permitted in food for human consumption. 21 C.F.R. 173 Subpart C.
"Under 21 U.S.C. § 350b, a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under 21 U.S.C. § 342(f)(1)(B) unless it meets one of two requirements:
1.The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
2. There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
"There is no information demonstrating that NR was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered. Further, ChromaDex submitted NDIN 882 for its NR product, NIAGEN®. On November 3, 2015, FDA notified ChromaDex of acceptance of the NDIN for NIAGEN® in accordance with 21 C.F.R. § 190.6 (c). To the best of ChromaDex's knowledge, Elysium has not submitted a NDI notification for the NR ingredient in its new Basis product in compliance with 21 U.S.C. § 350b(a)(2) and 21 C.F.R. § 190.6. As such, Basis should be found to be adulterated under §§ 342(f)(1)(B) and 350b(a).
"FDA should immediately require that Elysium cease distribution of its Basis product and take other appropriate enforcement action, including seizure of violating products and an injunction against the manufacturers and distributors under 21 U.S.C. §§ 332 and 334."