Quality Assurance and Quality
Control
Our Goal is Maximum Clinical Effectiveness
through Proven Quality!
Vital Nutrients is setting new standards for
Quality Assurance
Independent Testing of Raw Materials for Microbiology
Independent Testing for Raw Materials for Identification,
Authenticity, and Potency
Independent Testing for Heavy Metals
Independent Testing for Chemical Solvent Residue
Independent Testing for Herbicide, Pesticide and Fungicide Residue
Independent Testing of Herbal Raw Materials for Aflatoxin
Residue
Independent testing for Rancidity of Oil Products
Independent Testing for Dioxins & Dioxin Like Compounds
(All Fish Oils)
Independent Testing for PCBs (All Fish Oils)
Finished Product Expiration Date & Stability
Testing Program
Manufacturing Excellence
Vital Nutrients is the exclusive manufacturer for Cancer
Treatment Centers of America
More About Our Quality Verification
Quality Assurance and Quality Control are the
number one priority at Vital Nutrients.
While all natural product companies claim to have the best quality, almost
none are completing all the steps required to comprehensively insure that
quality and purity are consistently produced time after time. At Vital
Nutrients, no corners are cut when it comes to quality assurance. We provide
comprehensive proof and fully guarantee that our products are prepared
utilizing the highest standards of manufacturing practice and laboratory
quality assurance. Laboratory quality assurance is not easy to attain. We
audit and verify each of our independent laboratories to insure that
validated analytical methods and ethical lab practices for raw material and
finished product testing are followed. We spend a great deal of time
researching the scientific validity and reliability of laboratory test
methods. In addition, we insist that our labs use only highly purified
analytical reference standards. As a result of our efforts, we have often
found that many laboratories are not using proper reference standards and
scientifically valid testing methods. We reject the use of these
laboratories for testing of Vital Nutrients products. We will be happy to
provide you with a more detailed explanation of laboratory policies and
procedures if you have an interest in learning more.
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Our Goal is Maximum
Clinical Effectiveness through Proven Quality!
We have assembled a team of qualified health
professionals to assist us in our formulation of products. All Vital
Nutrients products are developed using bona fide research. In most cases,
the research used consists of published human and/or animal-based studies.
Our team of health professionals works diligently to ensure that the raw
materials chosen for our formulations work synergistically to produce the
best clinical outcome. We make certain that our products contain true
therapeutic doses and are made with the most beneficial active materials.
Vital Nutrients formulations are made with the ultimate goal of helping
people increase their health,
well-being and vitality, while easing discomfort and distress. We take this
goal very seriously, knowing that excellent raw material and finished
product quality assurance are the primary keys to producing consistent
clinical benefit
and value.
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Setting New Standards for Quality Assurance
Our Raw Material Is Always Independently Laboratory
Tested For:
• Microbiology Contamination — Bacteria, Yeast & Mold Counts
• Authenticity — Thin Layer Chromatography, HPLC, or Microscopy
Identification
• Potency — Assay by HPLC, GC or appropriate scientifically valid test
method
• Heavy Metals — Lead, Mercury, Cadmium, Arsenic and Aluminum to the parts
per billion level
• Multiple Chemical Solvent Residues — Tested by Gas Chromatography/Mass
Spectroscopy
• Aflatoxins — fungi toxins (All herbal products are tested for a panel of
Aflatoxins)
• Peroxides & Anisidines — Markers of Rancidity (All Oil products)
• Herbicide, Pesticide and Fungicide Residue — A panel of 136 chemicals (All
botanicals)
• 17 Dioxins & Dioxin-Like Compounds & 14 PCB’s — to the parts per trillion
level (All Fish Oil products)
Finished Product Is Always Independently Laboratory Tested For:
• Label Claim Potency — Assay by HPLC, GC or appropriate scientifically
valid test method
• Microbiology Contamination — Bacteria, Yeast & Mold Counts
Independent Laboratory Testing For Stability Profile & Expiration Date
Validation:
• Stability Assay at 12 months to Assure Potency
• Stability Assay at 24 months to Assure Potency
• Bacteria, Yeast & Mold Assay at 12 and 24 months to Assure a Clean Product
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Independent Testing of Raw Materials for
Microbiology
Vital Nutrients quarantines all purchased raw materials and
independently tests each and every lot for total aerobic bacterial count,
yeast and mold counts, Salmonella species, E. coli, Pseudomonas aeruginosa
and Staphylococcus aureus.
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Independent Testing of Raw Materials for
Identification, Authenticity and Potency
Vital Nutrients raw materials are tested to verify identity, authenticity
and potency. Our quality assurance department is constantly investigating
and expanding its knowledge to choose the most reputable labs and
scientifically valid testing methods and reference standards. Unfortunately,
the natural products laboratory industry is as unregulated and unreliable as
the nutritional supplement industry. This makes it difficult to get accurate
results. Vital Nutrients goes the extra mile to help ensure our raw
materials and finished products are tested by highly qualified personnel
using appropriate sample preparation, instrumentation, ethical and valid
scientific testing methodology and authentic reference standards. Our
testing has resulted in the rejection of many raw materials that do not meet
our specifications.
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Independent Testing for Heavy Metals
All botanical products, and minerals prone to toxic metal contamination, are
tested for the presence of lead, mercury, cadmium, arsenic, and aluminum to
the parts per billion level.
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Independent
Testing for Chemical Solvent Residue
Vital Nutrients independent laboratory tests all raw materials for chemical
and solvent residue. Many vitamins, minerals, amino acids and botanical
products are manufactured using one or more chemicals or chemical solvents.
Currently the natural products industry has no limits on chemical or solvent
residue allowed in natural products. Vital Nutrients uses and complies with
the allowable chemical and solvent limits for the pharmaceutical industry.
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Independent Testing for Herbicide, Pesticide and Fungicide Residue
Every botanical product we use gets tested for residual amounts of a variety
of herbicides, pesticides and fungicides. Our independent lab uses methods
developed by the California Department of Food and Agriculture (CDFA). The
State of California uses these same methods for rapid determination of a
large number of pesticides in a wide variety of crops for its enforcement
programs. We test for 61 different Organochlorines, 56 Organophosphates and
Organonitrogens, and 19 Carbamates. This is a total of 136 different tests
for each and every lot of botanical product we purchase.
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Independent Testing of
Herbal Raw Materials for Aflatoxin Residue
Aflatoxins are toxic metabolites produced by certain fungi that are in
or on foods and plant materials. Four different aflatoxins, B1, B2, G1 and
G2, have been identified with B1 being the most toxic, carcinogenic and
prevalent. Aflatoxins are probably the best known and most intensively
researched fungal toxins in the world. Aflatoxins have been associated with
various diseases, such as aflatoxicosis in livestock, domestic animals and
humans throughout the world. Aflatoxins have received greater attention than
any other fungal toxins because of their demonstrated potent carcinogenic
effect in susceptible laboratory animals and their acute toxicological
effects in humans. Many countries have attempted to limit exposure to
aflatoxins by imposing regulatory limits on food and feed for animals. The
US FDA has set a limit of less than 20ppb for total aflatoxins in food and
feed. Every botanical product we buy is tested for residual amounts of
aflatoxins and must meet our specification before we allow the material to
be used in production.
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Independent testing for Rancidity of Oil
Products
Our lipid softgel products are tested for primary oxidation by-products
(peroxide levels) and secondary oxidation by-products (anisidine levels). A
high level of either is indicative of rancidity of long chain fatty acids.
It is critical to test for both as peroxides are transitory and can drop to
a low level as they transform into secondary oxidation by-products (anisidines).
In addition, we test for acid value which is a third rancidity marker. Our
fish oil softgels and liquids are assayed and checked for EPA/DHA content,
total fatty acid profile, rancidity, heavy metals i.e mercury, lead,
cadmium, and arsenic to the ppb (parts per billion) level, 17 dioxins and
dioxin like compounds, and a comprehensive PCB panel, both to the ppt (parts
per trillion) level. GLA-containing products and flax softgels are assayed
and checked for GLA content, total fatty acid profile, heavy metals,
herbicide, pesticide and fungicide residue, solvent residue (if applicable),
aflatoxins and dual rancidity testing.
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Independent Testing
for Dioxins & Dioxin Like Compounds (All Fish Oils)
(All Fish Oils) What is “DIOXIN”? Dioxin is a generic term used to describe
a family of 210 compounds. The most dangerous of this family are 17 members
of this group (the ones Vital Nutrients tests for) characterized by the
presence of chlorine atoms in the 2, 3, 7, and 8 positions. Each of those 2,
3, 7, 8-substituted congeners has been assigned a Toxic Equivalent Factor (TEF),
which is used for the computation of the Toxic Equivalency Quotient (TEQ).
This scale is used in risk assessment studies to calculate the probability
of causing cancer and other life threatening diseases in humans.
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Independent Testing for PCBs (All Fish Oils)
(All Fish Oils) PCBs (Polychlorinated biphenyls) are a mixture of individual
chemicals, which are no longer produced in the United States, but are still
found in the environment. Health effects that have been associated with
exposure to PCBs include acne-like skin conditions in adults and
neurobehavioral and immunological changes in children. PCBs are known to
cause cancer in animals. The Department of Health and Human Services (DHHS)
has concluded that PCBs may reasonably be anticipated to be carcinogens. The
EPA and the International Agency for Research on Cancer (IARC) have
determined that PCBs are probably carcinogenic to humans. Vital Nutrients
minimizes Dioxin and PCB exposure with its parts per trillion assay method
and very strict acceptance criteria.
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Finished Product Expiration Date & Stability
Testing Program.
We are the first professional natural product manufacturer to put into place
a finished product, expiration date, and stability-testing program. This
program provides us with independent laboratory test data points to
guarantee that our products meet 100% of label claim and validates our
published expiration date. Most other natural product suppliers do not do
this amount of rigorous testing and data collection to evaluate their
product stability. In fact, many companies just arbitrarily make up the
expiration date and have no data to back it up. We start with a 24-month
expiration date for most of our products. We base this dating on information
furnished by our suppliers. To authenticate this dating on an ongoing basis,
we put our products through analytical and microbiological tests as well as
several visual inspections. Independent laboratories test our finished
products after manufacturing to insure label claim potency. We then repeat
the tests on a retained sample from that same lot at 12 months and 24 months
to check label claim potency. The first 3 lots of each individual
manufactured finished product will be tested. This gives us 9 data points to
use as information to authenticate our expiration date. Our independent lab
testing verifies purity, potency, and label claim. At each data point we
will be evaluating the product to see if we need to add an overage to make
up for any deficiency in potency or alter the expiration date. Of course,
this is in addition to the testing we do on each and every batch of raw
materials to insure authenticity, potency, and lack of contamination prior
to manufacturing.
Vital Nutrients provides a guaranteed and trustworthy product, and we make
copies of our independent lab assays and records available upon request.
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Manufacturing Excellence
Vital Nutrients manufactures its supplements in a clean, strictly controlled
facility that we monitor and supervise. Our products are not produced by an
outside contractor. We know precisely what goes into our products, and most
importantly we know what is not in the product. This allows us to produce
products that are free of unacceptable binders, excipients and other
potential allergy-causing or undesirable additives. Our facility has a full
time Quality Assurance and Quality Control Manager.
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Vital Nutrients is the exclusive manufacturer for Cancer
Treatment Centers of America
Cancer Treatment Centers of America (CTCA) has chosen Vital Nutrients to be
their exclusive manufacturer of products for their nutrition division,
Cancer Nutrition Centers of America. CTCA’s concern is that their products
meet the highest standards of quality assurance, meet label claim potency,
are manufactured free of contamination, and are properly formulated to
adequately provide nutrition and treatment for their cancer patients. The
same quality assurance and clinically relevant formulas that CTCA expects
are provided to you, our Vital Nutrients healthcare professional.
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You can depend upon us to provide the
finest quality natural products. We provide “proven and verifiable” quality
and supply practitioners with clinically effective products and formulas. As
always, we welcome your comments, feedback and suggestions on how to improve
our products or service. Thank you.
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Read
More About Our Quality Verification
Natural Product
Quality Assurance, Who cares?
The tools
Who manufactures the Products?
Quality Assurance Issues
Raw Materials Sourcing
Raw Material Microbiology Testing
Raw Material Verification Assay
Rancidity Testing of Oil Softgels
Heavy Metal Testing
Manufacturing
Label Management and Reconciliation
Finished Product Testing
Expiration Dating
Sample Retention
Lot Tracking System
Vendor audits
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