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| THE TRUTH ABOUT THE QUALITY OF DIETARY SUPPLEMENTS by Lynda Arredondo, CNE | |  The FDA has deemed that the Quality Systems Regulation for food, drugs, biologics, and medical devices are known as Good Manufacturing Practices. A GMP certification is what distinguishes top quality Nutraceuticals (pharmaceutical grade nutritional supplements) from ordinary dietary supplements. Dietary supplements are considered food and cannot be patented because they are naturally occurring compounds. According to the Dietary Supplement Health and Education Act of 1994, “A firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading.” In other words, dietary supplements are not required to be approved by the FDA before they are marketed. The Current Good Manufacturing Practices will help to ensure that manufacturers produce properly labeled and unadulterated dietary supplements. In June 2007 the FDA ruled that the CGMP includes requirements for the design and construction of physical plants that facilitate maintenance cleaning, proper manufacturing operations, quality control procedures, testing final product or incoming and in process materials, handling consumer complaints, and maintaining records.Small companies manufacturing dietary supplements must be compliant by June 2010. Large discount houses selling dietary supplements should already be compliant with CGMP but don’t have any current ratings or certifications from the CGMP.Are you really getting the levels of EPA and DHA in your fish oil that are stated on the label when you buy them at the discount warehouses? How do these discount companies ensure that their fish oil is free of mercury and PCB’s? The truth is that they aren’t independently tested and aren’t manufactured in warehouses that are CGMP rated for supplement production. They may be cheaper but are they effective? Are you actually getting what the label states? Wouldn’t you rather spend your money on Nutraceuticals that you know will be effective, are bio-available, and free of chemicals, pollutants, and additives? Look for Nutraceuticals manufactured by CGMP rated companies and spend your money where it counts- on your health. | |
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