Why Choose Anabolic Labs?
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Why You Should Choose Anabolic Laboratories’ Nutritional
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Regulation & The Law:
The federal law governing dietary supplements is the Dietary Supplement Health and Education Act of 1994 (a.k.a. DSHEA). This law pertains primarily to labeling and health claims applied to dietary supplements. The laws for manufacturing dietary supplements consist of food safety standards and contain no provisions for specific quality standards other than producing a safe product. Pharmaceutical Standards: Pharmaceutical manufacturing is governed by US law, found in the Code of Federal Regulations 211. Pharmaceutical companies are subject to an FDA audit every 12 months. If their protocols from A-Z are not proper, said company may be shut down, fined, and potentially, criminal prosecution. It is imperative for pharmaceutical companies, to comply with federal standards and meet label claims for products. Voluntary Higher Standards: Certain industry groups have developed voluntary good manufacturing practice (GMP’s) guidelines as a measure to ensure qualified standards of manufacturing. The original group to develop GMP’s and certify facilities via an external auditing inspection is the National Nutritional Foods Association (NNFA.org). Anabolic Laboratories was involved with the development of the NNFA program and its facility was used as a model for the guidelines. The only other group to offer external auditing and grant manufacturing standards compliance is the United States Pharmacopia (USP.org). At this point the USP is confined to 10% of mass market products. USP more traditionally has published monographs for identification and potency of raw materials which are an industry standard for laboratory procedures. Quality Assurance: Anabolic Laboratories’ quality assurance is done in house, not by outside, independent testing labs. Some supplement companies have recently marketed specific dollar figures they spend per month of outside testing...Anabolic Laboratories, Inc. performs approximately 4-5 times that dollar amount per month for in house testing. This is the cost for a modern, contract pharmaceutical company to maintain its FDA license for pharmaceutical manufacturing. Anabolic Laboratories’ in-house quality assurance labs perform 3rd party contract testing for other companies! Manufacturing Issues: Last year, Anabolic Laboratories, Inc. produced a batch of 500,000 chewable multivitamins. The post-production assay revealed that folic acid levels were low, which were not detected during the batch testing performed during manufacturing. Some how the blending procedure was inconsistent. Consequently, all 500,000 tablets were destroyed. Would other companies make such a shrewd manufacturing decision? Who knows? There is no regulation stating they’d have to! More likely, the company would not be aware that there was a problem with the production run because they did not have the Rx nutritional manufacturing knowledge and capability to perform the specific assay to catch the problem. Raw Material Fraud: Several years ago, Anabolic Laboratories, Inc. received a supply of CoQ10 from a raw material supplier. Samples were tested, which is the common procedure for ALL raw materials entering the Anabolic Laboratories manufacturing facility. The HPLC results generally suggested that the material might be CoQ10, but there were inconsistent results, suggesting that something was wrong with the material. The sample was then tested with a photodiode array detector. It turns out that the "CoQ10" was really riboflavin and folic acid. Without this in-house testing it would be impossible to establish that this material was NOT CoQ10. Anabolic Laboratories is the only nutrition company that services the chiropractic profession that also manufactures pharmaceuticals. No company can compare when it comes to manufacturing details and quality assurance. This does not mean that other companies do not have good products, or what they claim is on their label is not in the supplement. However, with Anabolic Laboratories, it’s guaranteed. Manufacturing standards: Anabolic Laboratories uses NNFA GMP guidelines and has an “A rating” for both the Irvine, CA and Tempe, AZ facilities. Anabolic Laboratories manufactures its dietary supplements under many of the same GMP's for pharmaceutical manufacturing established by the United States Food and Drug Administration (USFDA fda.gov). |
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