Fda 2017 P 5082 0003

August 18, 2017
By Electronic Submission to www.regulations.gov
Division of Dockets Management

Food and Drug Administration
Room 1061, HFA-305
5630 Fishers Lane
Rockville, MD 20852
CITIZEN PETITION TO FIND ELYSIUM HEALTH, INC.'S

BASIS PRODUCT TO BE ADULTERATED
Petitioner, ChromaDex, Inc. ("ChromaDex")1, respectfully submits this petition, pursuant

to 10 C.F.R. 10.25 and 10.30, to request that the Commissioner of Food and Drugs (the
Commissioner) at the Food and Drug Administration ("FDA") investigate and take appropriate
remedial action against Elysium Health, Inc. ("Elysium"), which has made, offers for sale and
sells, as a dietary supplement, a product named Basis.2
Elysium's Basis product is a composition of nicotinamide riboside chloride and

pterostilbene. 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"). In the past, ChromaDex supplied Elysium with
NIAGEN for use in its Basis product. However, Elysium is now using a new supplier(s) for the
ingredients in Basis, the identity of which is currently unknown. ChromaDex discovered, as
shown in the laboratory report attached as Exhibit 1, that 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.
1
ChromaDex discovers, acquires, develops, and commercializes patented and proprietary
ingredient technologies in the dietary supplement, food, beverage, skin care, and pharmaceutical
markets.
2
Elysium is a Delaware corporation with its principal place of business located at 594
Broadway, Suite 707, New York, New York. It describes itself as a company that utilizes science
and technology to create consumer health products.
A. Action Requested
ChromaDex specifically requests the following actions take place:
I. 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.
II. 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.
B. Statement of Grounds
BACKGROUND
ChromaDex
ChromaDex makes and sells NIAGEN, a patented, proprietary health ingredient that is
comprised of nicotinamide riboside chloride (NR). NR is a form of vitamin B3. NR is a
precursor to Nicotinamide Adenine Dinucleotide (NAD+), which is an essential molecule
found in every living cell. ChromaDex also makes pTeroPure, a patented, proprietary health
ingredient made of pterostilbene.3
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.4
In the regulatory filing, ChromaDex informed FDA that it proposed to use NIAGEN as a sole
active ingredient in a dietary supplement capsule formulation. Excipients will be approved food
additives, Generally Recognized As Safe (GRAS) ingredients or listed in Capsule and Tablet
3
Pterostilbene is an antioxidant found in blueberries and some grape varieties.
4
ChromaDex submitted additional information to FDA on October 13 and 30, 2015.
2
Ingredients of NNFA List of Dietary Supplement Ingredients In Use Before October 15,
1994.
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.
Elysium and its Basis Product
Elysium sells one product called "Basis." It represents to the public that Basis is
"[d]esigned with over 25 years of aging research, Basis is clinically proven to increase NAD+
levels."5 According to Elysium, "Basis is a clinically-validated formulation designed to support
well-being at the cellular level." The two active ingredients in Basis are NR (250 mg) and
pterostilbene (50 mg) per serving.
Elysium's website states that nicotinamide riboside is: "A direct precursor to the
coenzyme NAD+, which the body uses to power metabolism." As to pterostilbene, Elysium
states: "A powerful and bioavailable polyphenol similar to resveratrol, but more bioavailable.
Pterostilbene is created by plants to protect against internal and external stresses." Elysium
represents that Basis contains others ingredients, namely Microcrystalline Cellulose,
Hypromellose, Vegetable Magnesium Stearate and Silica. Elysium's website includes a link to its
label for Basis. The supplement facts panel directs users to take two vegetarian capsules per day.
Elysium represents that Basis contains no animal products and that the product is vegetarian,
vegan, gluten-free, nut-free, and contains no artificial colors or flavors. Finally, Elysium
represents to the public that:
Exceeds FDA Recommendations
The ingredients in Basis have been tested for safety and are produced in facilities
that meet FDA requirements. Basis also undergoes rigorous third party purity
testing.
The "purity testing" link allegedly reflects purity information for lot number 0271-6170.
5
See Elysium's website, https://www.elysiumhealth.com (last accessed August 18, 2017).
3
Elysium's website also emphasizes the "purity" of its supply chain: "During the course of
manufacturing Basis there are a total of five quality and purity audits before a batch is shipped.
All manufacturing facilities are located in the US and are compliant with the cGMP regulations
as stipulated by the FDA." Elysium does not disclose that Basis contains toluene, a residual
solvent.
In 2014, ChromaDex entered into certain agreements to supply Elysium with the
NIAGEN and pTeroPure products as the two active ingredients in Basis. ChromaDex has not
supplied Elysium with additional NIAGEN or pTeroPure since August 2016.
ChromaDex recently learned that Elysium is no longer using NIAGEN as the NR

ingredient in Basis. In order to investigate concerns about a counterfeit product, ChromaDex,
obtained commercially available Basis products from multiple sources for product testing. A
series of analyses were performed on eight Elysium Basis product samples received from various
persons in July and August 2017. A copy of the testing report is attached as Ex. 1 and
incorporated by reference.
The report shows there were visually observed differences in both product color and
statements made on the packaging containers. The Elysium Basis that arrived in July 2017 had a
tan to brown color, which is consistent with the color of ChromaDex's NIAGEN product. The
August samples, however, were white and homogenous in color, which indicates a difference in
the formulation. Further, the packaging on the samples had different lot numbers (July 0278
6170, August 0711 7150). The lid of the containers had a foil seal for lot 0278 6170 and a
white seal for lot 0711 7150. There were other packaging differences the containers received
in August removed patent markings, the printing font of the lot code and expiration date on the
bottom of the containers were different, and the label was changed from Metabolic Repair &
Optimization to Cellular Health and Optimization. The July and August samples also had
different expiration dates.
There were multiple chemical differences observed in the data between the samples
obtained in July and those that arrived in August. The testing shows that the July samples were
made with NIAGEN supplied to Elysium by ChromaDex. The August samples, however,
contain ingredients from a source other than ChromaDex.
The NR potency analysis indicated the NR present in the lots of Elysium Basis met Label
claims of 250 mg/serving. The NR and nicotinamide impurity evaluation indicated the presence
of a new unknown impurity in all four samples received in August that is not significantly
present in the NR ingredient lots ChromaDex sold to Elysium. Further, the absence of the NR
monoacetate peak, which is a known minor compound in ChromaDex's product is not present in
the four samples received in August.
The pterostilbene potency analysis indicated the pterostilbene present in the lots of Basis
met label claims of 50 mg/serving.
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
4
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, as further discussed below.
The NMR analysis confirmed the eight Elysium Basis product samples were structurally
the beta form of NR. There was a slight variation in the 1H NMR peak intensity and presence at
~2 ppm between the Elysium samples that were received in July as opposed to those in August.
This variation further supports the lack of the NR monoacetate peak in the Elysium Basis
samples received in August that is consistent with the NR analysis by HPLC. The 19F NMR
spectrums confirm the product is not the triflate salt form and does not contain any other fluorine
salts.
The metals analysis indicated a different metals composition between the July and
August Basis samples. Lead, molybdenum, and zinc were not detected in the July samples but
were detected in the August samples.
Thus, the report concludes, the Basis product samples received in July were different
from those received in August. 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.
ARGUMENT
I. Elysium's New Basis Product Is Adulterated With Toluene.
A food shall be deemed to be adulterated, among other things, if "it bears or contains any
poisonous or deleterious substance which may render it injurious to health; but in case the
substance is not an added substance such food shall not be considered adulterated under this
clause if the quantity of such substance in such food does not ordinarily render it injurious to
health." 21 U.S.C. 342(a)(1).
The evidence shows that Elysium's new Basis product, containing ingredients from an
unknown source other than ChromaDex, contain a deleterious substance that renders it injurious
to health. The residual solvents analysis using GC-MS shows the presence of different solvents
in the July and August samples. See Ex. 1 Tables 5 and 6. ChromaDex's NR does not contain
toluene and the solvent is not detected in the July samples.6 Toluene was affirmatively detected
in the August 2017 samples.7 The laboratory report shows that the August 2017 samples showed
toluene present in an amount ranging from 96-144 mg/kg. 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
6
Toluene was absent from ChromaDex's NDIN 882.
7
The laboratory report shows that the August samples also contained other solvents in trace
concentrations ethanol, ethyl acetate and DCM.
5
The presence of a toxic industrial solvent in Basis raises health and safety concerns.
Toluene ingestion is injurious to health. In September 2015, the Center for Disease Control
issued a Public Health Statement warning of a "serious health concern" that toluene may have an
effect on the nervous system (brain and nerves).
Nervous system effects can be temporary, such as headaches, dizziness, or

unconsciousness. However, effects such as incoordination, cognitive impairment,
and vision and hearing loss may become permanent with repeated exposure,
especially at concentrations associated with intentional solvent abuse. High levels
of toluene exposure during pregnancy, such as those associated with solvent
abuse, may lead to retardation of mental abilities and growth in children. Other
health effects of potential concern may include immune, kidney, liver, and
reproductive effects.
Available at https://www.atsdr.cdc.gov/ToxProfiles/tp56-c1-b.pdf (last accessed Aug. 18, 2017).
Because Elysium's new Basis product is adulterated, 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.
II. Elysium's Basis Product Contains A New Dietary Ingredient And Is Adulterated.
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.
As discussed above, ChromaDex's NIAGEN, is the only source of NR that has

sufficient preclinical and clinical safety data to establish that it is reasonably expected to be safe
and the only source of NR that has an NDIN filed by the FDA.
6
Based on the results of the testing, the new Basis product contains counterfeit (i.e., non-
NIAGEN) material. ChromaDex last supplied NIAGEN to Elysium in 2016. The laboratory
report demonstrates both visual and chemical difference between the samples received in July
and August 2017.
To the best of ChromaDexs knowledge, 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.
CONCLUSION
For the foregoing reasons, the petition should be granted.
C. Environmental Impact
The action requested in this petition is subject to categorical exclusion under 21 C.F.R.
25.32.
D. Economic Impact
Pursuant to 21 C.F.R. 10.30(b), ChromaDex would be willing, only when requested by

the Commissioner and following review of the petition, to submit additional economic impact
information on the effect of this requested action.
E. Certification
The undersigned certifies, that, to the best knowledge and belief of the undersigned, this
petition includes all information and views on which the petition relies, and that it includes
representative data and information known to ChromaDex that are unfavorable to the petition.
7
Sincerely,
Frank Jaksch
Founder and CEO
ChromaDex, Inc. (NASDAQ: CDXC)
8
EXHIBIT 1
Elysium Basis Summary Report
Customer: ChromaDex Ingredients Report Number: CDXA-PR-341-00

Address (City,
State): Irvine, CA Date Received: See Below
Boulder, CO;
Longmont, CO;
Purchase Order: N/A Test Location: Sub34, Sub51
Date of Report: 11-Aug-17

Project Number(s): ORD98237; ORD98162; ORD98159; ORD98161; ORD98992; ORD98994;
ORD98995; ORD98996
This product analysis is subject to our Standard Terms and Conditions for the Purchase and Sale of ChromaDex Products and or
Services, a copy of which has been provided to our client and is incorporated herein by this reference. As more specifically set forth
therein, this product analysis is for the benefit of our client only, may not be relied upon by any other party without our prior written
consent, relates solely to the sample(s) provided to us by our client and therefore cannot be applied to any other material or sample.
Unless otherwise noted, samples were received in acceptable condition and analyzed as received. This document may not be
printed in part without the explicit permission of ChromaDex
10005 Muirlands Blvd., Suite G, Irvine, CA 92618 | T: +1 949-419-0288 | F: +1 949-419-0294 | www.chromadex.com

CDXA-PR-341-00 Page 2 of 44
Assay: Nicotinamide Riboside (NR) & Nicotinamide in NR Ingredient by

HPLC; Pterostilbene by HPLC; Chain of Custody; NMR with C13,
Proton (1H), and 2D COSY, and Fluorine with Interpretation; Full Metal
Panel Testing; Elemental Analysis on C, H, and N, Cl, Br; Residual
Solvents
CDA-00101291; CDA-00100717; CDA-00100739; CDA-00101231; PRJ-
Part Number: General; CDA-00100116; PRJ-GC-MS
Prepared By: Aron Erickson 11-Aug-17

Director of Technology Date
Reviewed By:
Date
Approved By:
Quality Assurance Manager Date
Signed original on file at CDXA
This product analysis is subject to our Standard Terms and Conditions for the Purchase and Sale of ChromaDex Products and or
Services, a copy of which has been provided to our client and is incorporated herein by this reference. As more specifically set forth
therein, this product analysis is for the benefit of our client only, may not be relied upon by any other party without our prior written
consent, relates solely to the sample(s) provided to us by our client and therefore cannot be applied to any other material or sample.
Unless otherwise noted, samples were received in acceptable condition and analyzed as received. This document may not be
printed in part without the explicit permission of ChromaDex
x INTRODUCTION
In June of 2016, five nicotinamide riboside chloride (NR Cl) ingredient lots (40C910-15214-21,
40C910-15216-21, 40C910-15217-21, 40C910-15218-21, 40C910-15219-21) were sold to Elysium
Health, Inc. from ChromaDex, Inc. These ingredient lots were formulated in Elysiums Basis
product. Elysium Basis product samples have been sent to ChromaDex from various
individuals for evaluation by utilizing multiple analytical techniques. These techniques include
chromatographic analysis by HPLC and GC/GC-MS (pterostilbene, NR, nicotinamide, and
residual solvents), elemental analysis (C, H, N, Cl, Br), NMR (13C, 1H, and Fluorine), and ICP-MS
(metals).
Initially, four samples of Elysium Basis were sent in July of 2017 to ChromaDex Analytics, Inc. in
Longmont, CO. Another four samples were sent in August of 2017. The samples were received
with chain of custody forms and submitted for analytical evaluation. The evaluation involves a
comparison of the data between each lot of Elysium Basis and against the original data
generated for the five NR Cl ingredient lots sold to Elysium Health, Inc.
x SUMMARY
A series of analyses were performed on eight Elysium Basis product samples received from
various parties in July and August of 2017. There were multiple differences that were observed
in the data between the samples that arrived in July and those that arrived in August. It is
highly suspected that the NR Cl ingredient material in the Elysium Basis product lots (0701 7150
and 0711 7150) that arrived in August is of a different source.
The NR Cl potency analysis indicated the NR Cl present in the lots of Elysium Basis met Label
claims of 250 mg/serving. The NR Cl and nicotinamide impurity evaluation indicated the
presence of a new unknown impurity in all four samples received in August (CDXA-17-009625,
CDXA-17-009626, CDXA-17-009627, CDXA-17-009628) that is not significantly present in the NR
Cl ingredient lots sold to Elysium. Further, the absence of the NR monoacetate peak, which is
a known minor compound in the NR Cl ingredient supplied by ChromaDex, Inc., is not present
in these four sample lots as well.
The pterostilbene potency analysis indicated the pterostilbene present in the lots of Elysium
Basis met label claims of 50 mg/serving.
The residual solvents analysis indicated the presence of 4 new solvents in the Elysium Basis
sample lots received in August of 2017. The Elysium Basis sample lots received in July were
indicative of containing the known solvents present in the NR Cl ingredient supplied by
ChromaDex, Inc. The new solvents detected in the Elysium Basis sample lots received in
August are ethanol, ethyl acetate, dichloromethane (DCM), and Toluene. Ethanol, ethyl
acetate and DCM were present in trace concentrations, but Toluene was present at 96-144
mg/kg.
The elemental analysis confirms the presence of chloride which suggests the NR present in the
Elysium Basis products is the chloride form. Bromide was not detected in any of the Elysium
samples.
The NMR analysis confirmed the eight Elysium Basis product samples were structurally the beta
form of NR. There was a slight variation in the 1H NMR peak intensity and presence at ~2 ppm
between the Elysium samples that were received in July as opposed to those in August. This
This product analysis is subject to our Standard Terms and Conditions for the Purchase and Sale of ChromaDex Products and or Services, a
copy of which has been provided to our client and is incorporated herein by this reference. As more specifically set forth therein, this product
analysis is for the benefit of our client only, may not be relied upon by any other party without our prior written consent, relates solely to the
sample(s) provided to us by our client and therefore cannot be applied to any other material or sample. Unless otherwise noted, samples were
received in acceptable condition and analyzed as received. This document may not be printed in part without the explicit permission of
ChromaDex
variation further supports the lack of the NR monoacetate peak in the Elysium Basis samples
received in August that is consistent with the NR Cl analysis by HPLC. The 19F NMR spectrums
confirm the product is not the triflate salt form and does not contain any other fluorine salts.
The metals analysis indicated a difference in metals composition between the Elysium Basis
samples received in July and those received in August. Lead, molybdenum, and zinc were
detected in the Elysium Basis product lots that were received in August whereas the lots
received in July these metals were non-detect.
Visually and chemically the Elysium Basis product samples received in July were different from
those received in August. The compositional differences in the product elude to a different
source of NR Cl that was not supplied by ChromaDex, Inc. present in the lots received in
August. The impurity differences, solvents present, metals composition all support a new
source of NR Cl must be present in the formulation.
x SAMPLE(S) ANALYZED:
Sample Description: Lot #: Expiration Date: CDXA Number: Date Received:
Elysium Basis 0278 6170 11/2018 CDXA-17-008626 11-Jul-17

Elysium Basis 0701 7150 06/2019 CDXA-17-009625 02-Aug-17
ChromaDex
x SAMPLE(S) RECEIVED FROM:
Name(s) and Address(s) CDXA Number: Project Number:
CDXA-17-008626 ORD98237
CDXA-17-008546 ORD98162
CDXA-17-008544 ORD98159
CDXA-17-008545 ORD98161
CDXA-17-009625 ORD98992
CDXA-17-009626 ORD98994
CDXA-17-009627 ORD98995
CDXA-17-009628 ORD98996
ChromaDex
x PICTURES OF SAMPLE(S) RECEIVED:
CDXA-17-008626 (ORD98237)
ChromaDex
CDXA-17-008546 (ORD98162)
ChromaDex
CDXA-17-008544 (ORD98159)
ChromaDex
CDXA-17-008545 (ORD98161)
ChromaDex
CDXA-17-009625 (ORD98992)
ChromaDex
CDXA-17-009626 (ORD98994)
ChromaDex
CDXA-17-009627 (ORD98995)
ChromaDex
CDXA-17-009628 (ORD98996)
ChromaDex
x VISUAL COMPARISON OF ELYSIUM BASIS SHIPMENTS
The Elysium Basis product lots from the July 2017 and August 2017 received samples were
compared for visual product and packaging variations. There were observed differences
in both product color and statements made on the packaging containers.
The lots of Elysium Basis that arrived in July of 2017 had observed variation in color with
noticeable tan and white particles present in the product. This is indicative of NR Cl
supplied from ChromaDex, Inc. being present in the formulation as the NR Cl product is
slightly tan to brown in color. However, the product lots received in August of 2017 were
white and homogenous in color which indicates a difference in the formulation. A
representative comparison of each of the lots (July 0278 6170, August 0711 7150) is in
Image 1. It was also observed that the lid of the container had a foil seal in lot 0278 6170
and a white seal in lot 0711 7150.
Additional packaging differences were also noticed on the containers received in

August. These include removal of the patent protection statement (Image 2), the printing
font of the lot code and expiration date on the bottom of the containers (Image 3), and
the Elysium Basis slogan was changed from Metabolic Repair & Optimization to Cellular
Health and Optimization (Image 4).
Image 1: Packaging and capsule product color variation in a representative lot received
in July of 2017 (0278 6170) and August of 2017 (0711 7150).
ChromaDex
Image 2: Patent protection statement removed in representative lot 0711 7150 (August
2017) as compared to lot 0278 6170 (July 2017).
ChromaDex
Image 3: The Elysium Basis lot and expiration printing font changed in August 2017 as
compared to July 2017.
ChromaDex
Image 4: The Elysium Basis product slogan changed from Metabolic Repair & Optimization
to Cellular Health & Optimization on the lot containers received in August 2017 (0711
7150).
x SAMPLE ANALYSES PERFORMED:

- Nicotinamide Riboside and Nicotinamide by HPLC
- Pterostilbene by HPLC
- Metals by ICP-MS
- Residual Solvent Presence by GC-MS
- Elemental Analysis (C, H, N, Cl, Br)
- NMR Analysis (1H, 13C, 19F)
ChromaDex
x RESULTS & DISCUSSION
Nicotinamide Riboside (NR) & Nicotinamide Analysis by HPLC
The five NR Cl ingredient lots and the Elysium Basis products were analyzed for NR Cl and
nicotinamide. The impurity profiles were also examined during the analysis and
compared.
The NR Cl concentrations in the Elysium Basis products were analyzed against a NR Cl

reference standard and these values are in NR Cl equivalents (the elemental analysis was
performed separately to verify the chloride content of the samples). The NR Cl in the
Elysium Basis product lots all met the specified label claim at greater than 250 mg per
serving (Table 1). NR Cl concentrations ranged from 279 mg to 297 mg.
Nicotinamide was also quantified in the Elysium Basis materials. The nicotinamide was
observed to be much lower in the Elysium Basis samples received in August of 2017 (~1.4
mg) than in the samples received in July of 2017 (~6-7 mg). The samples received in
August also have a later expiration date than the samples received in July. This suggests
the materials used to formulate the product may be newer and the nicotinamide riboside
ingredient lot used is from a different source.
Nicotinamide Nicotinamide Riboside Chloride

CDXA# Lot
Specification/Serving Result Specification/Serving Result
CDXA-17-008626 0278 6170 NA 7.28 mg 250 mg 285 mg
CDXA-17-008544 0279 6170 NA 7.24 mg 250 mg 281 mg
CDXA-17-008546 0281 6170 NA 5.96 mg 250 mg 279 mg
CDXA-17-008545 0281 6170 NA 6.59 mg 250 mg 285 mg
CDXA-17-009625 0701 7150 NA 1.38 mg 250 mg 286 mg
CDXA-17-009626 0711 7150 NA 1.16 mg 250 mg 285 mg
CDXA-17-009627 0701 7150 NA 1.40 mg 250 mg 292 mg
CDXA-17-009628 0711 7150 NA 1.40 mg 250 mg 297 mg
Table 1: NR Cl and Nicotinamide potency in Elysium Basis product samples.
The HPLC chromatograms obtained of the NR Cl ingredient lots and Elysium Basis samples
from the HPLC analysis were also compared. The impurity profiles in the chromatograms
of the ingredient lots and Elysium Basis samples received in July of 2017 were very similar
and did not indicate the presence of new or varying impurities (Figures 1 - 3). However,
when the impurity profiles of the Elysium Basis samples received in August 2017 were
analyzed and compared to the NR Cl ingredient lots and the Elysium Basis samples
received in July, a difference was observed. The nicotinamide riboside monoacetate
peak that is present in the ingredient lots, was not present in the Elysium Basis product
samples (CDXA-17-009625, CDXA-17-009626, CDXA-17-009627, and CDXA-17-9628)
received in August (Figures 4 and 5). Further, an unknown impurity (26.0 min) was
observed in these lots, eluting closely to that of NR. This suggests the NR Cl ingredient
present in the product lots of Elysium Basis received in August is from a different source.
ChromaDex
CDXA-PR-341-00 Pa
age 19 of 4
44
DAAD1 B, Sig=270,4 Ref=360,100 (C:\C

CHEM32\CARSON\DATA\2015\L29 15A\L2915_000006.D)
2 2 .4 4 3
mAU
26
3.
93
:1
ea
Ar
6
13
04
4
A2r .6 9 9
7.
:1
ea
2 0
95
A1r 8 .8 6 8
5.
:1
1 .6 5 4
ea
5
11
70
A2r .5 6 2
.5
:0
ea
-2
2.5 5 7.5 10 12.5 15 17.5 20 22.5 min
Figure 1: HPLC chromatogram (zo oomed) of a representative Chroma aDex, Inc. NR

R Cl
0-15219-21) sold
ingredient lot (40C910 s to Elysiu m in June of 2016 depic
cting the pre
esence of
Nicotinamide (2.7 minn), NR monoacetate (1 8.7 min), and d NR (22.4 min).
Figure 2: HPLC chromatogram of Elysium Basi s product samples CDXA A-17-008544,, CDXA-
17-008545, CDXA-17-0 008546, CDXA-17-00862 6, and NR Cl ingredient m material from
m
ChromaDex, Inc. dep picting the presence of nicotinamide (2.9 min), N
NR monoace etate
(20.3 min), and NR (23
3.5 min) receeived in July of 2017.
This product analysis is subject to our Standarrd Terms and Conditions for the Purchase and Sa ale of ChromaDex Products and d or Services, a
copy of which has been provided to our client and is incorporrated herein by this reference. As more specific cally set forth the
erein, this product
analysis is for th
he benefit of our client only, may not be relied upon
u by any ot her party without our prior written
n consent, relate es solely to the
sample(s) provided to us by ou ur client and the
erefore cannot be
b applied to an ny other material or sample. Unle ess otherwise notted, samples we ere
received in acceptable condition and analyzed as received. This document m may not be printed in part witho out the explicit ppermission of
ChromaDex
CDXA-PR-341-00 Pa
age 20 of 4
44
Figure 3: HPLC chromatogram (zo oomed) of E lysium Basis product sam

mples CDXA--17-
008544, CDXA-17-0085 545, CDXA-17-008546, CDXA-17-0086 626, and NR Cl ingredien
nt
material from ChromaaDex, Inc. deepicting th e presence o
of NR monoaacetate (20.33 min)
and NR (23.5 min) rec
ceived in July
y of 2017.
DAD1 B, S g=270, Ref=360,1 00 (H0317\H0317_000019.D)
DAD1 B, S g=270, Ref=360,1 00 (H0317\H0317_000009.D)
DAD1 B, S g=270, Ref=360,1 00 (H0317\H0317_000011.D)
DAD1 B, S g=270, Ref=360,1 00 (H0317\H0317_000013.D)
DAD1 B, S g=270, Ref=360,1 00 (H0317\H0317_000015.D)
DAD1 B, S g=270, Ref=360,1 00 (H0317\H0317_000017.D)
288 2 31 70 - Nicotinamide R oside Cl

mAU
150
8
95
25
a:
re
100
7
2 . 28.
9
50
3 - Nicotinam de
487
99
89
33
.13
1104
437
22.123
.629
A2.628
A2.63
A26.015
25.979
7.3
2
8
a:
ree
a:
re
-50
0 5 10 15 20 25 min
Figure 4: HPLC chromatogram of Elysium Basi s product samples CDXA A-17-009625,, CDXA-
17-009626, CDXA-17-0 009627, CDXA-17-00962 8, NR Cl ingre
edient material from ChrromaDex,
Inc., and a diluent bla
ank depicting the presen
nce of nicotinamide (2.6 6 min), NR
monoacetate (22.1 min),
m an unknnown (26.0 mmin), and NR
R (28.5 min).
This product analysis is subject to our Standarrd Terms and Conditions for the Purchase and Sa ale of ChromaDex Products and d or Services, a
copy of which has been provided to our client and is incorporrated herein by this reference. As more specific cally set forth the
erein, this product
analysis is for th
he benefit of our client only, may not be relied upon
u by any ot her party without our prior written
n consent, relate es solely to the
sample(s) provided to us by ou ur client and the
erefore cannot be
b applied to an ny other material or sample. Unle ess otherwise notted, samples we ere
received in acceptable condition and analyzed as received. This document m may not be printed in part witho out the explicit ppermission of
ChromaDex
DAD1 B, S g=270, Ref=360,100 (H0317\H0317_000019.D)

DAD1 B, S g=270, Ref=360,100 (H0317\H0317_000009.D)
DAD1 B, S g=270, Ref=360,100 (H0317\H0317_000011.D)
DAD1 B, S g=270, Ref=360,100 (H0317\H0317_000013.D)
DAD1 B, S g=270, Ref=360,100 (H0317\H0317_000015.D)
DAD1 B, S g=270, Ref=360,100 (H0317\H0317_000017.D)
17
3
Cl
mAU
.8
28. 70 - Nicotinam de RAbo28.e39
95
25
ti a
a
re
3
7
31 399
2 62A2 628 A . A2. 9 .
.
12 14
8
a: ea:
.7
re r
4
23
2
.1
10
a:
re
22.123
0
89
3131
4737
5. 979
77 .3
A26.015 7
aa: :
A25
ree
-1
-2
0 5 10 15 20 25 min
Figure 5: HPLC chromatogram (zoomed) of Elysium Basis product samples CDXA-17-

009625, CDXA-17-009626, CDXA-17-009627, CDXA-17-009628, NR Cl ingredient material
from ChromaDex, Inc., and a diluent blank depicting the presence of nicotinamide (2.6
min), NR monoacetate (22.1 min), an unknown (26.0 min), and NR (28.5 min).
Pterostilbene by HPLC
The Elysium Basis product samples received were analyzed for pterostilbene potency. The
pterostilbene present in the materials met the product label specification of 50 mg (Table
2).
Pterostilbene
Lot# Specification/Serving Result
CDXA-17-008626 0278 6170 50 mg 55.8 mg
CDXA-17-008544 0279 6170 50 mg 54.7 mg
CDXA-17-008546 0281 6170 50 mg 55.1 mg
CDXA-17-008545 0281 6170 50 mg 56.6 mg
CDXA-17-009625 0701 7150 50 mg 55.2 mg
CDXA-17-009626 0711 7150 50 mg 57.5 mg
CDXA-17-009627 0701 7150 50 mg 54.9 mg
CDXA-17-009628 0711 7150 50 mg 57.9 mg
Table 2: Pterostilbene potency in Elysium Basis product samples.
ChromaDex
Residual Solvents by GC-MS
The Elysium Basis product samples were analyzed by GC-MS to detect the presence and
confirm identity of the solvents that are present. The samples received in July of 2017 were
consistent with the presence of solvents in the ChromaDex, Inc. supplied NR Cl ingredient
(Table 3). However, the samples received in August of 2017 had four additional solvents
detected in the GC-MS analysis including ethanol, ethyl acetate, dichloromethane
(DCM), and toluene (Table 4). The Elysium Basis product samples were investigated further
to determine the concentration of each of these solvents present by GC-FID (Tables 5 &
6). Ethanol, ethyl acetate and DCM were all present just at or below the reporting limit
(BRL) in the Elysium Basis samples received in August 2017. Toluene was also present, but
at a higher concentration ranging from 96 to 144 mg/kg. This again suggests the NR Cl
present in the samples received in August 2017 is from a different source.
Lot 0279 6170 0281 6170 0281 6170 0278 6170

CDXA# CDXA-17-008544 CDXA-17-008545 CDXA-17-008546 CDXA-17-008626
Ethanol Not Detected Not Detected Not Detected Not Detected
Acetone Present Present Present Present
MTBE Not Detected Not Detected Not Detected Not Detected
Methyl Acetate Trace Trace Trace Trace
Ethyl Acetate Not Detected Not Detected Not Detected Not Detected
Methanol Present Present Present Present
Acetonitrile Trace Trace Trace Trace
DCM Not Detected Not Detected Not Detected Not Detected
Toluene Not Detected Not Detected Not Detected Not Detected
Table 3: Solvent analysis presence by GC-MS of Elysium Basis product samples that
contain NR Cl supplied from ChromaDex, Inc. received in July of 2017.
Lot 0701 7150 0711 7150 0701 7150 0711 7150

Ethanol Present Present Present Present
Acetone Present Present Present Present
MTBE Trace Trace Trace Trace
Methyl Acetate Present Present Present Present
Ethyl Acetate Trace Trace Trace Trace
Methanol Present Present Present Present
Acetonitrile Not Detected Not Detected Not Detected Not Detected
DCM Trace Trace Trace Trace
Toluene Present Present Present Present
Table 4: Solvent analysis presence by GC-MS of Elysium Basis product samples that
contain NR Cl supplied from an unknown source received in August of 2017.
ChromaDex
Lot 0279 6170 0281 6170 0281 6170 0278 6170

Ethanol ND ND ND ND
Acetone 551 523 504 571
MTBE ND ND ND ND
Methyl Acetate BRL (14) BRL (10) BRL (10) BRL (12)
Ethyl Acetate ND ND ND ND
Methanol 207 169 172 190
DCM ND ND ND ND
Toluene ND ND ND ND
Table 5: Solvent concentration (mg/kg) analysis by GC-FID in Elysium Basis product
samples that contain NR Cl supplied from ChromaDex, Inc.
Lot 0701 7150 0711 7150 0701 7150 0711 7150

Ethanol BRL 21 BRL 17
Acetone 225 343 206 332
MTBE ND (3) BRL (8) ND (3) BRL (6)
Methyl Acetate BRL (10) 25 BRL (9) 24
Ethyl Acetate BRL (10) BRL (12) BRL (12) 15
Methanol 166 219 166 206
DCM ND (7) BRL (9) ND (7) BRL (10)
Toluene 98 141 96 144
Table 6: Solvent concentration (mg/kg) analysis by GC-FID in Elysium Basis product
samples that contain NR Cl supplied from an unknown source.
BRL Below Reporting Limit

ND Not Detected
ChromaDex
Elemental Analysis
The Elysium Basis product samples were also sent for elemental analysis to confirm the
presence of chloride and determine if the NR was the chloride salt. All Elysium Basis
product samples contained chloride signifying the NR in the formulation is the chloride
form (Tables 7 and 8). Bromide was not detected in any of the samples indicating the
bromide salt form is not present.
0279 6170 0281 6170 0281 6170 0278 6170

CDXA-17-008544 CDXA-17-008545 CDXA-17-008546 CDXA-17-008626
Rep 1 Rep 2 Rep 1 Rep 2 Rep 1 Rep 2 Rep 1 Rep 2
Carbon 46.69 46.83 46.34 46.36 46.87 47.03 47.01 46.88
Hydrogen 5.67 5.84 5.90 5.92 5.95 6.07 5.91 5.89
Nitrogen 3.61 3.74 3.26 3.23 2.77 2.66 3.84 3.95
Chloride 5.69 5.52 5.69 5.54 5.32 5.22 4.69 4.58
Bromide 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Table 7: Elemental analysis of the Elysium Basis samples containing NR Cl from ChromaDex,
Inc. that arrived in July 2017.
0701 7150 0711 7150 0701 7150 0711 7150

CDXA-17-009625 CDXA-17-009626 CDXA-17-009627 CDXA-17-009628
Rep 1 Rep 2 Rep 1 Rep 2 Rep 1 Rep 2 Rep 1 Rep 2
Carbon 46.22 46.07 48.21 48.33 46.15 46.21 48.31 48.18
Hydrogen 5.86 5.79 5.67 5.55 5.70 5.73 5.47 5.58
Nitrogen 4.69 4.69 6.22 6.29 4.75 4.63 6.38 6.27
Chloride 5.93 6.05 8.02 8.02 5.86 6.01 8.00 8.08
Bromide 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Table 8: Elemental analysis of the Elysium Basis samples containing NR Cl from an unknown
source that arrived in August 2017.
NMR Analysis
The 1H and 13C NMR comparison, in both the July and August received samples, indicates
the NR Cl is beta NR Cl form (Figures 6-11). The data in the 1H also supports the non-
presence of the NR monoacetate peak in the Elysium Basis samples that contain a
different source of NR Cl which is consistent with the NR Cl analysis by HPLC. The peaks of
sample CDXA-17-009625 around the 2 ppm decrease, indicating that a mono-acetylated
NR are no longer present as compared to CDXA-17-008544 where the peaks are much
more prevalent (Figure 8). The 19F NMR analysis does not indicate the presence of the
triflate salt form or any additional fluorine salts (Figures 12-13). Note: A minor peak at ~ -100
ppm was noticed in a few of the Fluorine NMR spectrums. This was caused by the
processing software and is determined to be an artifact of the analysis. It was not present
during the acquisition of the data.
ChromaDex
Lot: 0279 6170 0281 6170 0281 6170 0278 6170

Reporting
Element Unit CDXA-17-008544 CDXA-17-008545 CDXA-17-008546 CDXA-17-008626
Limit
Aluminum ppm 2 23.9 6.49 6.55 6.9
Antimony ppm 0.02 ND ND ND ND
Arsenic ppm 0.08 ND ND ND ND
Barium ppm 0.04 0.169 0.0716 0.0602 0.0479
Beryllium ppm 2 ND ND ND ND
Cadmium ppm 0.02 ND ND ND ND
Calcium ppm 20 92.0 85.7 78.7 91.4
Chromium ppm 0.2 0.356 ND ND 0.207
Cobalt ppm 0.008 0.00900 ND ND ND
Copper ppm 0.4 ND ND ND ND
Iridium ppm 0.02 ND ND ND ND
Iron ppm 2 6.29 3.05 2.86 3.78
Lead ppm 0.02 ND ND ND ND
Magnesium ppm 4 622 647 643 579
Manganese ppm 0.08 0.156 ND ND 0.111
Mercury ppm 0.01 ND ND ND ND
Molybdenum ppm 0.04 ND ND ND ND
Nickel ppm 0.4 ND ND ND ND
Palladium ppm 0.02 ND ND ND ND
Phosphorus ppm 4 4.04 5.62 ND ND
Platinum ppm 0.02 ND ND ND ND
Potassium ppm 40 684 617 610 631
Rhodium ppm 0.02 ND ND ND ND
Ruthenium ppm 0.02 ND ND ND ND
Selenium ppm 0.1 ND ND ND ND
Silicon ppm 20 3,380 3,430 3,310 3,540
Silver ppm 0.004 ND ND ND ND
Sodium ppm 20 475 445 455 446
Thallium ppm 0.008 ND ND ND ND
Thorium ppm 0.004 ND ND ND ND
Uranium ppm 0.002 0.00298 ND ND ND
Vanadium ppm 0.1 ND ND ND ND
Zinc ppm 0.4 ND ND ND ND
Table 9: Metals analysis of the Elysium Basis samples containing NR Cl supplied from
ChromaDex, Inc. that arrived in July 2017.
ChromaDex
Lot: 0701 7150 0711 7150 0701 7150 0711 7150

Reporting
Element Unit CDXA-17-009625 CDXA-17-009626 CDXA-17-009627 CDXA-17-009628
Limit
Aluminum ppm 2 14.3 8.38 13.9 8.45
Antimony ppm 0.02 ND ND ND ND
Arsenic ppm 0.08 ND ND ND ND
Barium ppm 0.04 0.231 0.111 0.166 0.133
Beryllium ppm 2 ND ND ND ND
Cadmium ppm 0.02 ND ND ND ND
Calcium ppm 20 88.6 106 92.2 106
Chromium ppm 0.2 0.597 0.773 0.619 0.809
Cobalt ppm 0.008 ND ND ND 0.00752
Copper ppm 0.4 0.481 ND ND ND
Iridium ppm 0.02 ND ND ND ND
Iron ppm 2 7.91 5.03 6.17 5.62
Lead ppm 0.02 0.0328 0.0402 0.0343 0.0421
Magnesium ppm 4 615 556 489 533
Manganese ppm 0.08 0.135 0.123 0.0948 0.13
Mercury ppm 0.01 ND ND ND ND
Molybdenum ppm 0.04 0.104 0.104 0.104 0.0994
Nickel ppm 0.4 ND ND ND ND
Palladium ppm 0.02 ND ND ND ND
Phosphorus ppm 4 ND ND 4.31 4.44
Platinum ppm 0.02 ND ND ND ND
Potassium ppm 40 617 907 663 861
Rhodium ppm 0.02 ND ND ND ND
Ruthenium ppm 0.02 ND ND ND ND
Selenium ppm 0.1 ND ND ND ND
Silicon ppm 20 6150 5840 6710 5090
Silver ppm 0.004 ND ND ND ND
Sodium ppm 20 426 588 448 549
Thallium ppm 0.008 ND ND ND ND
Thorium ppm 0.004 0.00615 0.00528 0.00646 0.00461
Uranium ppm 0.002 0.00288 0.00276 0.00334 0.00235
Vanadium ppm 0.1 ND ND ND ND
Zinc ppm 0.4 2.03 2.07 1.99 1.94
Table 10: Metals analysis of the Elysium Basis samples containing NR Cl from an unknown
source that arrived in August 2017.
ChromaDex
METHODOLOGIES
Nicotinamide Riboside and Nicotinamide by HPLC
SOLUTION PREPARATION
Mobile Phase B: 2.0 mM Ammonium Formate in Water, pH 3.9

Solution was prepared by dissolving 126 mg of ammonium formate in 1000 mL of Milli-Q
water. The pH was adjusted to 3.9 with formic acid.
Mobile Phase A: 5% Mobile Phase B in ACN

Solution was prepared by combining 950 mL of ACN with 50 mL of Mobile Phase B and
mixing well.
Diluent: 20:80 Water:ACN

Solution was prepared by combining 800 mL of ACN with 200 mL of Milli-Q water and
mixing well.
INSTRUMENT PARAMETERS
Instrument Agilent 1100 Series HPLC System

Detection UV-Vis
Mobile Phase A 5% Mobile Phase B in ACN

Mobile Phase B 2 mM Ammonium Formate pH 3.9 (aq)
Gradient Program Time (min) %A %B

0.0 100 0
5.0 100 0
25 55 45
29.9 55 45
30 100 0
Column: Sequant ZIC-HILIC 150 x 4.6 mm, 5 m, 200

Flow Rate: 1.0 mL/min
UV Detection: 270 nm
Injection Volume: 5 L
Column Temperature: 30 oC
Autosampler Temperature: 4 oC
ChromaDex
SOLUTION PREPARATION
Mobile Phase A: 0.1% Formic Acid (aq)

Solution was prepared by adding 1.0 mL of formic acid to 1,000 mL of water in a suitable
container and mixing well. The solution prep may be scaled up or down as necessary.
Mobile Phase B: 0.1% Formic Acid in 95:5 ACN:Milli-Q H2O

Solution was prepared by adding 1.0 mL of formic acid to 50 mL of Milli-Q H2O and 950
mL of ACN. The solution prep may be scaled up or down as necessary.
INSTRUMENT PARAMETERS
Instrument Agilent 1290 Infinity II Series UHPLC System, or equivalent

Detection UV-Vis
Mobile Phase A 0.1% Formic Acid

Mobile Phase B 0.1% Formic acid in 95:5 ACN:Milli-Q H2O
Gradient Time %A %B
Program (min)
0.0 85 15
2.0 85 15
8.0 30 70
8.1 85 15
12.0 85 15
Column: Agilent SB-PHENYL 2.1 X 30mm 1.8m particle

UV Detection: 318 nm, bw 4.0 nm, no ref.
Injection Volume: 1.0 L

Column Temperature: 30C
Autosampler Temperature: 4C
ChromaDex
Residual Solvent Presence by GC-MS
GC INSTRUMENT PARAMETERS
Instrument: Agilent 7890B GC System with 5977A MSD

(or equivalent)
Column: Agilent J&W DB-624 UI 20 m x 0.180 mm x 1.00 m Capillary
GC Column (or equivalent)
Injection Volume: 250 L of headspace
Inlet Temperature: 200 C
Split Ratio: 10:1
Carrier Gas: Helium
Run Time: 18.1 min
Temperature Program: Initially 40 C for (5 minutes) to 240 C (2 minutes) @ 18 C/min
Detection: MSD
HEADSPACE AUTOSAMPLER
Headspace Autosampler: CTC Analytics/Leap Technologies CombiPAL Autosampler for

Liquid or Headspace injection (or equivalent)
Syringe: CTC Analytics/Leap Technologies CombiPAL 2.5 mL
Headspace syringe
Cycle: MACRO HS-NO4-V2
Incubation Temperature: 140 C
Incubation Time: 10 min
Vial Size: 20 mL
Agitator On Time: 5 sec
Agitator Off Time: 2 sec
Syringe Temperature: 145 C
Agitator Speed: 500 rpm
Fill Speed: 100 L/s
Pullup Delay: 1 sec
Injection Speed: 1000 L/s
Pre-Injection Delay: 0.5 sec
Flush Time: 3 min
GC Run Time: 18.1 min
MSD PARAMETERS
EI Source Temperature: 250 C

Quadrupole Temperature: 150 C
Transfer Line Temperature: 240 C
Tune File (s): atune.u (prior to calibration), Quicktune (for daily use)
Fixed Electron Energy: 70 eV
Acquisition Type: Scan
Trace Ion Detection: On
Gain Factor: 1
ChromaDex
Residual Solvent Quantitation by GC-FID
GC INSTRUMENT PARAMETERS
Instrument Agilent 5890 GC System

Detection Dual FID
Columns Restek Siltek Deactivated Guard Column 5 m x 0.32 mm

connected to an MTX Y-union connected to:
Zebron ZB-624, 30 m x 0.32 mm I.D. x 1.80 m
Zebron ZB-WAXPlus 30 m x 0.32 mm I.D. x 0.25 m
Inlet Temperature 250 oC

Carrier Gas Helium
Flow Rate 5.0 mL/min through each column
Injection Volume 1.0 mL of headspace
Initial Temperature 35 oC
Initial Time 10 min
Detector Temperature 250 oC
Split Ratio 4:1
Oven Temperature Level Rate Final Temp Final Time

Program (oC/min) (oC) (min)
Initial N/A 35 10
1 10 220 28.5
2 0 220 33.5
HEADSPACE PARAMETERS
Headspace: Tekmar 7000

Platen Temperature: 140 C
Platen Equilibration time: 0.10 min
Sample Equilibration time: 5.00 min
Vial Size: 20 mL
Mixer: On (Mix Power 5)
Mix: 10.00 min
Stabilize: 0.50 min
Pressure: 0.20 psi
Pressure Equilibration time: 0.30 min
Loop Fill time: 0.10 min
Loop Equilibration time: 0.05 min
Inject: 1.00 min
Sample Loop Temperature: 230 C
Line Loop Temperature: 240 C
GC Cycle time: 55 min
Constant Head: N (See GC Cycle time)
Carrier Gas: Helium
Vial Fill Pressure: 13 psi
Vial Fill Flow: 20 mL/min
ChromaDex
Metals by ICP-MS
Reference: USP <2232>
Elemental Analysis
The elemental analysis was sent to a third-party lab and is analyzed by a combustion
method.
NMR Analysis
The samples for NMR analysis was sent to a third party for data acquisition.
The NMR spectra were acquired at 300 K immediately after sample dissolution using a
Bruker Avance III 400 MHz NMR spectrometer:
- A 64 scan 1H spectrum (Bruker zg30 pulse program (12/01/2011))
- A 2048 scan 13C{1H} spectrum (Bruker zgpg30 pulse program (12/01/2011))
- A 256 scan 19F{1H} spectrum (Bruker zgfhigqn.2 pulse program (12/01/2011))
ChromaDex
REFERENCES
Assay Report
CDXA-ARS-37500-00
CDXA-ARS-37501-00
CDXA-ARS-37502-00
Nicotinamide Riboside (NR) & CDXA-ARS-37503-00
Nicotinamide in NR Ingredient by HPLC CDXA-ARS-37936-00
CDXA-ARS-37937-00
CDXA-ARS-37938-00
CDXA-ARS-37939-00
CDXA-ARS-37483-00
CDXA-ARS-37480-00
CDXA-ARS-37481-00
CDXA-ARS-37482-00
CDXA-ARS-37940-00
CDXA-ARS-37941-00
CDXA-ARS-37942-00
CDXA-ARS-37943-00
CDXA-ARS-37683-00
CDXA-ARS-37684-00
CDXA-ARS-37685-00
CDXA-ARS-37686-00
Metals by ICP-MS
CDXA-ARS-38002-00
CDXA-ARS-38003-00
CDXA-ARS-38004-00
CDXA-ARS-38005-00
CDXA-ARS-37669-00
CDXA-ARS-37670-00
CDXA-ARS-37671-00
CDXA-ARS-37672-00
Elemental Analysis
CDXA-ARS-37981-00
CDXA-ARS-37982-00
CDXA-ARS-37983-00
CDXA-ARS-37984-00
REVISION HISTORY
Revision Number Document/Changes
00 New report
ChromaDex
APPENDIX
Chain of Custodys
ChromaDex
ChromaDex
ChromaDex
ChromaDex

Fda 2017 P 5082 0003

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August 18, 2017

By Electronic Submission to www.regulations.gov

Division of Dockets Management

CITIZEN PETITION TO FIND ELYSIUM HEALTH, INC.'S

Petitioner, ChromaDex, Inc. ("ChromaDex")1, respectfully submits this petition, pursuant

Elysium's Basis product is a composition of nicotinamide riboside chloride and

ChromaDex specifically requests the following actions take place:

I. Make a determination that Elysium's Basis product is adulterated under 21 U.S.C.

NIAGEN was generally recognized as safe by an independent panel of expert

On November 3, 2015, FDA notified ChromaDex of acceptance of the NDIN for

NIAGEN is manufactured by the method described in NDIN 882. The NR product

Elysium and its Basis Product

Exceeds FDA Recommendations

ChromaDex recently learned that Elysium is no longer using NIAGEN as the NR

I. Elysium's New Basis Product Is Adulterated With Toluene.

Nervous system effects can be temporary, such as headaches, dizziness, or

Available at https://www.atsdr.cdc.gov/ToxProfiles/tp56-c1-b.pdf (last accessed Aug. 18, 2017).

As discussed above, ChromaDex's NIAGEN, is the only source of NR that has

To the best of ChromaDexs knowledge, there is no information demonstrating that NR

For the foregoing reasons, the petition should be granted.

Pursuant to 21 C.F.R. 10.30(b), ChromaDex would be willing, only when requested by

Customer: ChromaDex Ingredients Report Number: CDXA-PR-341-00

Date of Report: 11-Aug-17

10005 Muirlands Blvd., Suite G, Irvine, CA 92618 | T: +1 949-419-0288 | F: +1 949-419-0294 | www.chromadex.com

Assay: Nicotinamide Riboside (NR) & Nicotinamide in NR Ingredient by

Prepared By: Aron Erickson 11-Aug-17

Signed original on file at CDXA

Sample Description: Lot #: Expiration Date: CDXA Number: Date Received:

Elysium Basis 0278 6170 11/2018 CDXA-17-008626 11-Jul-17

x SAMPLE(S) RECEIVED FROM:

Name(s) and Address(s) CDXA Number: Project Number:

x PICTURES OF SAMPLE(S) RECEIVED:

x VISUAL COMPARISON OF ELYSIUM BASIS SHIPMENTS

Additional packaging differences were also noticed on the containers received in

x SAMPLE ANALYSES PERFORMED:

x RESULTS & DISCUSSION

Nicotinamide Riboside (NR) & Nicotinamide Analysis by HPLC

The NR Cl concentrations in the Elysium Basis products were analyzed against a NR Cl

Nicotinamide Nicotinamide Riboside Chloride

DAAD1 B, Sig=270,4 Ref=360,100 (C:\C

2.5 5 7.5 10 12.5 15 17.5 20 22.5 min

Figure 1: HPLC chromatogram (zo oomed) of a representative Chroma aDex, Inc. NR

Figure 3: HPLC chromatogram (zo oomed) of E lysium Basis product sam

288 2 31 70 - Nicotinamide R oside Cl

DAD1 B, S g=270, Ref=360,100 (H0317\H0317_000019.D)

Figure 5: HPLC chromatogram (zoomed) of Elysium Basis product samples CDXA-17-

Residual Solvents by GC-MS

Lot 0279 6170 0281 6170 0281 6170 0278 6170

Lot 0701 7150 0711 7150 0701 7150 0711 7150

Lot 0279 6170 0281 6170 0281 6170 0278 6170

Lot 0701 7150 0711 7150 0701 7150 0711 7150

BRL Below Reporting Limit

0279 6170 0281 6170 0281 6170 0278 6170

0701 7150 0711 7150 0701 7150 0711 7150

Lot: 0279 6170 0281 6170 0281 6170 0278 6170

Lot: 0701 7150 0711 7150 0701 7150 0711 7150

Nicotinamide Riboside and Nicotinamide by HPLC

Mobile Phase B: 2.0 mM Ammonium Formate in Water, pH 3.9

Mobile Phase A: 5% Mobile Phase B in ACN

Diluent: 20:80 Water:ACN

Instrument Agilent 1100 Series HPLC System

Mobile Phase A 5% Mobile Phase B in ACN

Gradient Program Time (min) %A %B