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Additional Article Information: =============================== 424 Words; formatted to 65 Characters per Line Distribution Date and Time: 2008-09-03 12:24:00 Written By: Norm Howe Copyright: 2008 Contact Email: mailto:[EMAIL PROTECTED] For more free-reprint articles by Norm Howe, please visit: http://www.thePhantomWriters.com/recent/author/norm-howe.html ============================================= Special Notice For Publishers and Webmasters: ============================================= If you use this article on your website or in your ezine, We Want To Know About It. 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As such, FDA's Department of Health and Human Services recently rolled out new dietary supplement regulations. The 815-page document, titled "Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements", reflects the final ruling on the subject. In short, this ruling establishes the good manufacturing practice for dietary supplements, outlining the minimum standards necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of said dietary supplement. According to the ruling, testing methods must be scientifically valid. The ruling proposes that tests must include at least one of the following: (1) Gross organoleptic analysis, (2) microscopic analysis, (3) chemical analysis, or (4) other appropriate test. (The requirement that methods be scientifically valid applies to all the tests and examinations manufacturers use, rather than to quantitative tests alone, thus the term ''analytical'' is not used.) While the proposed definition of ''appropriate test'' (i.e., ''a scientifically valid method'') mandates specific methods, some manufacturers are concerned because valid test methods are not always available for testing dietary ingredients or dietary supplements. In response to that concern, the ruling states: ''If an AOAC or FDA method is not available, a scientifically valid analytical method is one that is based on scientific data or results published in, for example, scientific journals, references, text books, or proprietary research...We recognize that certain tests for identity, purity, quality, strength, or composition for certain finished product may not be available due to complex finished matrices that would make such testing impracticable." In addition, manufacturers may exempt a product specification from the verification requirements if they show that: (1) The specifications selected to verify that the product meets all product specifications are not able to verify that the control system is producing a dietary supplement that meets the exempted product specification and (2) there is no scientifically valid method for testing or examining the exempted product specification at the finished batch stage. Beyond this ruling, FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. For more information see http://www.fda.gov/OHRMS/DOCKETS/98fr/cf0441.pdf or call an experienced consultant to gain more insight into your particular question. --------------------------------------------------------------------- Norm Howe, Senior Partner at Validation and Compliance Institute, consultants for the pharmaceutical and medical device industries. He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA. He has held many management positions in FDA regulated industries, most at BASF. http://www.vcillc.com --- END ARTICLE --- Get HTML or TEXT Copy-and-Paste Versions Of This Article at: http://thePhantomWriters.com/free_content/db/h/dietary-supplements-must-be-tested.shtml#get_code ..................................... 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