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When It Comes to High Quality Dietary Supplements, New Federal Guidelines for Good Manufacturing Are Only Part of the Story

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. For more information about Metagenics, please visit Metagenics at Meta-eHealth