This
pharmaceutical company is
one of the BEST. I have personally met with
the doctors and owners of this company at the American Academy of
Anti-Aging conferences and I am convinced that they have the best
fish oil in the world.
Nutrients.
While all natural product companies claim to have the best quality,
almost none are completing all the steps that are 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 do what is required to
provide comprehensive proof and fully guarantee that your products
are delivered to you and your patients utilizing the highest standards
of manufacturing practices 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 being 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.
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.
Vital Nutrients quality assurance and manufacturing practices
are far superior to other nutritional supplement manufacturers.
You can trust and count on Vital Nutrients quality assurance,
not because we say so, but because we prove to you what we do.
As
of September 2004 we are one of only two professional natural
product manufacturing companies in the world that have been audited
and certified for Good Manufacturing Practices (cGMP) by both
the NNFA (National Nutritional Foods Association) and the NSF.
Our facilities are audited by these independent outside agencies
to third party certify and prove our compliance with GMP guidelines
and quality assurance practices. These two organizations are leaders
in natural product manufacturing quality assurance certification
in North America.
Vital Nutrients meets or in many cases exceeds the proposed FDA
cGMP’s (Current Good Manufacturing Practice Guidelines for nutritional
supplements). cGMP’s cover identity, authenticity and potency
testing of raw materials and finished products, quarantine/release
procedures, employee training, cleanliness of the facility, documentation,
as well as many other areas. We follow detailed written standard
operating procedures (SOP’s) to ensure consistency and safety
in every aspect of our manufacturing process. Vital Nutrients
uses the highest standards for Quality Assurance. This is why
we are the industry leader. Following is a brief description of
our leading edge quality assurance program.
Setting New Standards for Quality Assurance
Our Raw Material Is Always Independently Laboratory Tested For:
• Microbiology Contamination — Bacteria, Yeast & Mold
• 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 — All herbal products are tested for a panel of Aflatoxins
• Peroxides, Anisidines, Acid Value — Markers of Rancidity (All
Oil products)
• Herbicide, Pesticide and Fungicide Residue — All botanicals
(a panel of 136 chemicals)
• 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
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
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.
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.
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.
Independent Testing for Chemical 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. We
find out from each of our raw material suppliers if a chemical
or solvent has been used during the manufacture of a product.
If so, we test for
any residue of that chemical or solvent and reject material that
has unacceptable levels.
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.
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 gets tested for residual amounts of aflatoxins
and must meet our specification before we allow the material to
be used in production.
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 triple rancidity testing.
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.
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.
Finished Product Expiration Date & Stability Testing Program.
We are the first professional line natural product manufacturer
to put into place a finished product, expiration date and stability-testing
program. This program will give us independent laboratory test
data points which will guarantee that our products meet 100% of
label claim to the point of 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.
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 capsule. 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.
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 as well.
Doctor/Pharmacist
Formulated
Vital Nutrients manufactures its supplements in a clean, strictly
controlled environment that we monitor and supervise. Our products
are not produced by an outside contractor. We know precisely what
goes into our products and most important, we know what is not
in the capsule.
Vital Nutrients provides a guaranteed and trustworthy product,
and we make copies of our assays and records available upon request.
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