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Absorption & bio-availability matter...

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DR. DEEDRA MASON

ABSORPTION  & BIO-AVAILABILITY

Dr. Deedra Mason, ND, VP of Product Development & Clinical Education, discusses the importance, & efficacy, of isotonic-capable formulations.

DETAILED SCIENCE

PYCNOGENOL RESEARCH

With millions of dollars in research, Pycnogenol, a French maritime pine tree bark extract, stands out as the primary ingredient in nutraMetrix's #1 selling product, Isotonix OPC-3 (included in the Isotonix Daily Essentials Kit & trial package).

 

Click below for 3rd party science on the health applications of this trademarked ingredient.

DR. MARK LANGE

PRODUCT QUALITY  

& REGULATORY STANDARDS

Senior Director of Product Quality and Regulatory Standards, Dr. Mark Lange speaks about the importance of Quality Control.

FREQUENTLY ASKED QUESTIONS

What steps are taken to assure the quality and consistency of nutraMetrix products?

The following process assures the quality of our products:

  1. Specifications are set for raw materials and finished products.
  2. Raw materials are sourced with Certificates of Analysis.
  3. Products are manufactured using Standard Operating Procedures.
  4. Products are inspected at our warehouse for damage, label accuracy, appearance, taste and odor prior to release.
  5. A product is quarantined if it fails to pass inspection.
  6. Products are assayed by independent labs for isotonic capability, micro-contamination and potency.
  7. Manufacturing facilities are audited on a regular basis for GMP compliance.

Who oversees the quality of nutraMetrix products?

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.

I heard that the supplement industry is not regulated. Is this true?

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 mis-branded
  • 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 (GMP's) 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 to 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 the labels completely, and if you have any questions or concerns, ask your professional healthcare provider.

Are the natural ingredients used in nutraMetrix products screened for pesticides?

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.

Can I get a COA for nutraMetrix products?

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.

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