Frequently Asked Questions

Senior Director of Product Quality and Information, Dr. Mark Lange, is a nationally respected authority in dietary supplement testing methods and quality control. Dr. Lange received his Ph.D. in analytical chemistry at the University of Tennessee. With over 15 years of experience in the pharmaceutical and nutraceutical fields, he was formerly the founder and head of the Institute for Nutraceutical Advancement before arriving at nutraMetrix. Click here to read an interview with Dr. Mark Lange regarding the Quality Control Procedures used in manufacturing and distributing the nutraMetrix® product line.

The following process assures the quality of our products:

• Specifications are set for raw materials and finished products.
• Raw materials are sourced with Certificates of Analysis.
• Products are manufactured using Standard Operating Procedures.
• Products are inspected at our warehouse for damage, label accuracy, appearance, taste and odor prior to release.
• Product is quarantined if failing to pass inspection.
• Products are assayed by independent labs for isotonic capability, micro contamination and potency.
• Manufacturing facilities are audited on a regular basis for GMP compliance.

Supplements, as the word indicates, are formulated to supplement a diet of widely varied whole foods. A cup of fresh orange juice provides about 100 mg of vitamin C and clearly everyone would agree that this vitamin C is all "natural" because the vitamin came from food or a plant source.

The majority of the vitamin C used in dietary supplements is derived from dextrose (also called corn sugar). This vitamin C also originates from plants, but the conversion of sugar to vitamin C involves several enzymatic steps and purification of L-ascorbic acid on an industrial scale.

So is vitamin C from corn sugar "natural" or "synthetic?" It all depends upon your definition and upon the legal definition of "natural" and "synthetic" in the country where the supplement is sold. In fact, it is sometimes difficult to make the distinction between "synthetic" and "natural" vitamins. Furthermore most synthetically made vitamins and many other nutrients are either identical to their natural counterparts or easily convert to the natural form in the human body.

Many manufacturers of natural vitamin C claim they are superior to synthetic vitamins. However, there is no published data to support this. The Linus Pauling Institute, Oregon Health Sciences University, website states, "Natural and synthetic L-ascorbic acid are chemically identical and there are no known differences in their biological activities or bioavailabilities. (Gregory JF, 3rd. Ascorbic acid bioavailability in foods and supplements. Nutr. Rev. 1993; 51(10):301-303)

Some vitamin supplements are marketed as whole food supplements, purportedly supplying the known and unknown nutrients found in food. However, careful review of the labels making such claims reveals that the greater part of vitamins used in whole food supplements are synthetic, in that they originate in high-tech chemical manufacturing facilities. The synthetic vitamins are blended with plant and animal extracts to simulate the complexity of nutrients derived from eating whole foods. Therefore, "whole food" supplements are not necessarily derived only from natural food sources.

Furthermore, synthetic vitamins produced under quality controlled conditions have specific advantages:

• They are of highest purity
• Common allergens can be reduced or eliminated
• No genetically modified organisms
• No pesticide residue
• Highly concentrated nutrients
• Reduced costs
• No variability in potency

Considering these advantages and that in most cases there is no difference in bioavailability, the use of both natural and synthetic sources in supplements is appropriate and often beneficial.

All of our ingredients extracted from natural sources (such as pine bark, citrus, bilberry and grape seed) are tested for pesticide residue using gas chromatography.

Yes. The fish oil used in the nutraMetrix product is laboratory-tested for PCB, Dioxin and Heavy Metals. We only use fish oil that meets or exceeds standards set by Canada (CFIA), European Union (EU) and the United States (CRN). For example, cadmium, lead and arsenic cannot exceed 0.1 ppm and mercury cannot exceed 0.01 ppm in the fish oil.

Unfortunately, many people think that dietary supplements are not regulated, which simply is not the case. Dietary supplements are regulated by the U.S. Food and Drug Administration (FDA), although not like drugs, but instead like foods.

In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which established new standards for dietary supplement products. Specifically, the FDA has the power to:

• Stop any company from selling a dietary supplement that is adulterated or misbranded
• Stop the sale of a dietary supplement that makes false or unsubstantiated claims
• Take action against any dietary supplement that poses "a significant or unreasonable risk of illness or injury"
• Stop any company making a claim that a product cures or treats a disease
• Require dietary supplements to meet strict manufacturing standard, including potency, cleanliness and stability

The FDA assures that products are safe and accurately labeled, and dietary supplement manufacturers must notify the FDA of intended label claims and ensure that they can be substantiated.

The FDA has regulations on good manufacturing practices (GMPs) for dietary supplements. Under the rule, manufacturers are required to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements.

In December 2006, Congress passed The Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the "AER Bill".) This legislation requires the reporting of "serious" adverse events for dietary supplements. Many people believe that over time this reporting requirement will provide additional proof of the safety of dietary supplements.

So if you're wondering if dietary supplements are safe, the answer is yes, if used responsibly. However, consumers need to be aware of what supplements and amounts they're taking and how this may affect one's health or interact with prescription or over-the-counter drugs. Make sure to read labels completely, and if you have any questions or concerns, ask your professional healthcare provider.

Laboratory results require specialized knowledge and education to interpret correctly. The results are compared against pharmacopeial standards and the method error must be factored in. We do not release COAs to the public because they can easily be misused or misinterpreted. The quality of a product batch cannot be assumed to be acceptable just because the previous batch was within specification. Therefore, even if we did publish a COA for a particular lot number, it would be out of date with respect to the lot number being shipped from the warehouse within weeks. Checking batch records and test results is the responsibility of the Director of Quality Control. nutraMetrix acts as an independent QC check between the manufacturer and the consumer. We have no financial interest in any batch and if anything is not right, we quarantine the product and ship it back to the supplier.

Isotonix products make the label claim of being isotonic capable; When prepared as directed on the label, the solution is within a range of tonicity matching the human body. Periodic tests are conducted on these products to ensure that the isotonicity range is maintained.

The basis for the isotonic line is physiologic. Isotonic solutions work via normal body physiology to deliver nutrients quickly as compared to solid forms. These physiologic principles have been well described in the medical literature. Here are a few sample references:

• Ganong, WF Review of Medical Physiology, 13th ed. Norwalk, CT Appleton and Lange, 1987.
• Graham, DY, Smith, JL, Bouvet AA "What Happens to Tablets in the Stomach" Journal of Pharmaceutical Sciences 79 (5): 420-24, 1990.
• Hunt, "Mechanisms and Disorders of Gastric Emptying" Annual Review of Medicine, 1983.
• Seigel, JA "Biphasic Nature of Gastric Emptying" Gut 29: 35-39, 1988.
• Erdman, JW "Bioavailability of Trace Minerals from Cereal and Legumes", Cereal Chemistry 58(1), 1981.

There are several organizations and companies performing third-party GMP certification. These include NNFA, Shuster Labs, NSF International and USP. All of our suppliers of supplements have independent GMP certification to demonstrate compliance with regulations.

By working with a contract manufacturer, in contrast to being the onsite manufacturer, an extra layer of quality control is in place. Since we act as an intermediary between you and the manufacturer, we have no incentive or interest to receive, accept or ship out inferior, defective or a sub-par product. In fact it is just the opposite. Our name and reputation is on every carton, bottle, etc. making us especially committed to the best quality control measures.

Products must be manufactured using predefined ingredients to meet finished goods specifications. Batch records for each lot are sent to the nutraMetrix Quality Control (QC) department for review, approval and retention. Batch records document the ingredients used, blending times, equipment used and who did the work.

Laboratory test results performed in the manufacturers' lab are copied to nutraMetrix QC. Products are sent to an independent laboratory to assure adherence to specifications before shipping to the distribution warehouse.

Upon receipt at the warehouse, we examine for damaged goods, proper labeling, and consistency in taste, odor, and appearance. Our in-house lab tests nutraMetrix isotonic products for osmolality- confirming that when the product is made as directed, the solution is in the isotonic range.

Furthermore, any product found to be less than optimal is quarantined for destruction or return to the supplier. The manufacturer will bear the cost of returned goods. nutraMetrix is committed to accepting and distributing only superior, high quality products adhering to strict quality control procedures.

A vitamin may be broadly defined as a substance that is essential for the maintenance of normal metabolic function, but which is not produced in the body and therefore must be consumed from a source outside the body.

They are necessary elements in the process of converting food to energy and in the growth and repair of body tissue. Reduction of vitamin levels over extended periods can result in vitamin deficiency.

These shortages may lead to symptoms which can include loss of appetite, loss of body weight, increased irritability and sleeplessness or constant drowsiness. Deficiencies of this nature can be easily avoided by adequate vitamin intake.

Bioflavonoids are complex organic plant compounds. Plants and fruits differ in colors based on the specific bioflavonoids they contain. An increasing number of clinical studies have shown how bioflavonoids support health. Bioflavonoids found in OPC's play a key role in cardiovascular health and maintaining vascular integrity. Bioflavonoids have been shown to demonstrate support for healthy circulation and cell vitality. Normal collagen renewal is promoted, which supports firmness of the skin, joint cartilage and connective tissue.

Pycnogenol® is the registered trademark of Horphag Research (UK) Ltd. for a standardized extract of bark of the French maritime pine tree. Pycnogenol® is particularly renowned for its extensive clinical research with more than 120 studies published in peer-reviewed medical journals.

The flavonoids in Pycnogenol® not only act as powerful antioxidants, they also appear to promote the normal generation of nitric oxide, which plays a key role in regulating cardiovascular health. Nitric oxide promotes the normal relaxation of arteries, supports normal diameter of blood vessels and supports helps maintain healthy blood pressure and circulation.

Nitric oxide promotes normal platelet activity allowing the blood to maintain a normal, fluid viscosity. Pycnogenol® has been awarded various patents for its ability to support healthy platelet activity.

Even when eating a balanced diet, it is difficult to consume the optimal amounts of vitamins and minerals each day. Numerous studies have been conducted on the importance of vitamins and minerals. One should supplement with a multivitamin to assure that their daily nutrient intake is balanced and powerful enough to ward against any deficiencies, allowing for the best health possible.

Probiotics are beneficial organisms that promote a healthy intestinal tract environment. Probiotics can help support the body in maintaining proper digestive functions and improving emotional health. Lactobacillus sporogenes bacteria reside mostly in the large intestine and help break down undigested food. These "friendly" bacteria can help the absorption of vitamins and minerals and can actually synthesize some vitamins, such as biotin and vitamin K. In addition, these beneficial bacteria contribute to the breaking down of fibers and undigested starch into simple sugars. These simple sugars then function as fuel for the cells that line the large intestine.

nutraMetrix® DNA Miracles™ Isotonix® formulas are more effective than standard children's multivitamin formulas because they offer the best way to get the maximum delivery of vitamins and minerals into the bloodstream. Isotonix® formulas are also the fastest and most effective ways to receive multivitamins. The stomach has very little work to do because the pH and tonicity are carefully designed to allow the stomach to quickly release all the nutrients into the small intestine.

With nutraMetrix® DNA Miracles™ Isotonix® formulas, this process takes about five minutes, where a standard vitamin tablet can take up to four hours. Not only will children love the taste of nutraMetrix® DNA Miracles™ Isotonix® formulas, they will get wholesome nutrition without unnecessary binders and fillers which are evident in many children’s vitamins on the market today.