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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

 

 

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