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Metagenics Nutritional Products
Genetic Potential Through Nutrition
Science Backed by GMP Quality. Metagenics sets the standard for safety with stringent raw material selection and extensive testing for purity and quality. These exceptional products are manufactured in our facility certified for Good Manufacturing practices (GMP) to ensure optimal purity.
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Testimonials:
"Here's my story with the Metagenics Myocalm PM. I'd been taking Restoril for at least 3years nonstop for sleep. And still not sleeping terrifically every night. I had not realized it was addictive, either. So, when you suggested the MyocalmPM, I gave it a try. I cut my Restoril capsules in half for a week, and took that together with the MyocalmPM. After the week, I quit the Restoril and have been taking the Myocalm PM since - about 2 more weeks. I fall asleep easily, stay asleep (except when the cat is pushy) and, as long as I can get 7 hours sleep per night (not staying up late when I have to get up early) I'm starting to wake up feeling rested. I'm so glad you recommended it! Taking the Corvalen twice daily has made a difference, too! thanks for everything” susan, san diego
Metagenics Cenitol: "The Cenitol has helped me feel more relaxed. I am always running around doing things and I feel more composed than I normally do using this product". Vicki, Dublin, California
Metagenics Fibroplex & Bioenergy CorvalenM: These two products have helped with the aches and pains of fibromyalgia and chronic myofascial pain. I can do more than I did before taking these products. All of the Metagenics supplements are high quality and I would recommend them to anyone. Vicki, Dublin, California
GMP certification of a manufacturing plant is an excellent marker of quality. Metagenics' high quality nutritional supplements are manufactured in facilities inspected and certified by key organizations that may include:
- National Products Association (NPA, formerly known as the National Nutritional Foods Association or NNFA)
- National Sanitation Foundation (NSF International)
- Therapeutic Goods Administration of Australia (TGA)
There's a difference between GMP compliance and actual GMP certification. GMP compliance means that a company is monitoring itself on the adherence to GMP standards. GMP certification means that outside auditors ensure adherence to GMP standards.
GMP certification is not free. In fact, it's very expensive to implement-and it's an ongoing process. That's why many nutritional supplement manufacturers do not have these types of GMP certificates. But without actual GMP certification, you cannot be sure if they are adhering to GMP requirements.
The lists of U.S. companies certified for GMP aren't very long. Science -Based Nutraceuticals for Improved health. Metagenics nutraceuticals and medical foods are recognized around the world for setting the standard of high quality and purity. Their commitment to health is apparent with their investments in NPA, NSF International, and TGA GMP-certified manufacturing, comprehensive scientific evaluations and safety reviews and human clinical evaluations. With sophisticated research and manufacturing facilities and one of the largest scientific staffs in the industry, they continue to search for new ingredients and unprecedented formulas that offer even greater potential for natural health care.
Metagenics is the leading manufacturer and distributor of nutraceuticals and medical foods to health care practitioners in the United States with international distribution that includes Canada, Mexico, Puerto Rico, Japan, Australia, New Zealand, and countries throughout South America, Europe, and Asia. With this extensive history of successful clinical use around the world, in any language Metagenics means nutritional formulas you and your family can trust.
When It Comes to High Quality Dietary Supplements, New Federal Guidelines for Good Manufacturing Are Only Part of the Story, Metagenics Says
San Clemente, CA (April 16, 2008)—As dietary supplement manufacturers scramble to meet the approaching deadline for new Federal guidelines for safety and quality, Metagenics, Inc. recognizes that compliance with the FDA’s Dietary Supplement Current Good Manufacturing Processes (cGMPs) Final Rule, released in June 2007, is just the first step in building true quality into supplements. “We’re very pleased that the FDA has finally issued manufacturing standards that apply throughout our industry,” said Jeffrey S. Bland, PhD, Chief Science Officer of Metagenics, a life sciences company and leading manufacturer of nutraceuticals and medical foods sold to healthcare practitioners. “But to maximize the health benefits from nutritional supplementation, manufacturers have to go above and beyond the FDA cGMP guidelines for manufacturing and integrate identity testing of botanical ingredients and conduct comprehensive evaluation of safety and efficacy of ingredients.”
“Metagenics quality assurance procedures include these additional steps in establishing the quality of its nutraceuticals and medical food products,” added Bland. “By employing both identity testing and comprehensive ingredient evaluation for safety and reproducible composition, we’re confident that our products provide assurance of potency and safety,” he said.
Large manufacturers (500 or more employees) must comply with the Final Rule by June, 2008. Medium companies (20-499 employees) must comply by June, 2009, and small companies (fewer than 20 employees) have until June, 2010. The Final Rule does not apply to suppliers or producers of raw ingredients.
Based on the guiding principle that “quality cannot be tested into a product only at the end,” but rather, “must be built into the product throughout the manufacturing process,” the Final Rule establishes new guidelines for quality control, designing and constructing manufacturing plants, and identity testing of ingredients and the finished product—none of which was required before. Requirements for recordkeeping and handling consumer product complaints are also addressed.
Unfortunately, the Final Rule does not address ingredient quality and health benefits of the finished product. For example, two calcium tablets may be identity tested to contain 650 mg of calcium. However, if the quality of the calcium used in one tablet is more readily absorbed than the quality of the calcium in the other tablet, the first tablet will be more clinically effective. “This difference in quality is not accounted for by the new Rule,” said Bland. Furthermore, due to the FDA’s limited resources, onsite inspection is not required for a manufacturer to declare itself “cGMP-compliant.” In fact, because the FDA cannot inspect every manufacturing plant, a product will be considered mislabeled if its label states it is “produced in compliance with dietary supplement FDA cGMPs.”
Bland urged both healthcare practitioners and consumers to ask tough questions when selecting a dietary supplement. “Our health is too important to not ask these questions,” he said. These include:
- Does the product deliver the benefits stated on the label? Ingredient selection is crucial in natural supplements, but the Final Rule does not establish any standards for ingredient quality. For example, there are hundreds of strains of probiotics on the market, but not all have equal benefits.
- Is the manufacturer GMP-certified? Because manufacturers can declare themselves “cGMP compliant” without undergoing onsite inspection by the FDA, buyers should look for supplements produced by companies that are regularly audited and GMP-certified by industry-specific, credible, and independent organizations such as the Natural Products Association (NPA), the National Sanitation Foundation (NSF), or the Therapeutic Goods Administration of Australia (TGA).
- Have the individual ingredients undergone thorough, scientific evaluation and safety reviews? Rigorous scientific analysis is required to identify different levels of ingredient quality. Safety and/or effectiveness may be at risk with lower quality ingredients.
- Does the company employ a knowledgeable and experienced scientific staff to support the safety and efficacy of the product from start to finish? Most companies rely on “borrowed research,” while very few allocate the resources for an in-house scientific staff or state-of-the-art research facilities. To create true quality products a competent scientific staff is essential.
“Consumers who rely solely on FDA cGMP compliance aren’t getting the full measure of the quality of a product,” said Bland. “Companies committed to delivering high quality products that are safe and beneficial for their customers should actively be addressing these additional areas.”
About Metagenics, Inc.
Metagenics, Inc. is a life sciences company and leading developer and manufacturer of science-based nutraceuticals and medical foods sold to healthcare practitioners worldwide. It is headquartered in San Clemente, Calif. with manufacturing and multiple research facilities located in Gig Harbor, Wash., including its MetaProteomics® Nutrigenomics Research Center and its Functional Medicine Research CenterSM for human clinical research. Metagenics holds multiple proprietary formula patents and produces over 400 research-based products to optimize health. The company demonstrates its commitment to purity and quality through its certifications for Good Manufacturing Practices (GMP) from the NPA, NSF International, and TGA.
There's a difference between GMP compliance and actual GMP certification. GMP compliance means that a company is monitoring itself on the adherence to GMP standards. GMP certification means that outside auditors ensure adherence to GMP standards.
GMP certification is not free. In fact, it's very expensive to implement-and it's an ongoing process. That's why many nutritional supplement manufacturers do not have these types of GMP certificates. But without actual GMP certification, you cannot be sure if they are adhering to GMP requirements.
The lists of U.S. companies certified for GMP aren't very long. Science -Based Nutraceuticals for Improved health. Metagenics nutraceuticals and medical foods are recognized around the world for setting the standard of high quality and purity. Their commitment to health is apparent with their investments in NPA, NSF International, and TGA GMP-certified manufacturing, comprehensive scientific evaluations and safety reviews and human clinical evaluations. With sophisticated research and manufacturing facilities and one of the largest scientific staffs in the industry, they continue to search for new ingredients and unprecedented formulas that offer even greater potential for natural health care.
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