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The U.S. Food and Drug Administration (FDA) announced plans to publish a compliance guide that will provide assistance to small dietary supplement manufacturers. Additional Article Information: =============================== 440 Words; formatted to 65 Characters per Line Distribution Date and Time: 2009-01-05 11:00:00 Written By: Norm Howe Copyright: 2009 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. Use the following URL to let us know where you have used this article, and we will include a link to your website on thePhantomWriters.com: http://thephantomwriters.com/notify.php?id=6477&p=load HTML Copy-and-Paste and TEXT Copy-and-Paste Versions Of Article Are Available at: http://thePhantomWriters.com/free_content/db/h/dietary-supplement-manufacturers.shtml#get_code --------------------------------------------------------------------- Proposed FDA Compliance Guide to Assist Small Dietary Supplement Manufacturers Copyright (c) 2009 Norm Howe Validation and Compliance Institute http://www.vcillc.com The U.S. Food and Drug Administration (FDA) announced plans to publish a compliance guide that will provide assistance to small dietary supplement manufacturers who are trying to implement good manufacturing practices (cGMP) legislation. In 2007, the final rule of the GMP legislation was passed, which provided standards specific to supplements for purity, safety and legality in manufacturing. In June 2008, big companies (over 500 employees) were required to implement these new standards. Mid-sized firms must implement the new standards by no later than June 2009, and small firms (less than 20 employees) have until June 2010. The director of the FDA?s Division of Dietary Supplements Programs, Dr. Vasilios Frankos, recently stated that guidelines are in the works, including the aforementioned Small Entity Compliance Guide. The FDA defines a dietary supplement as ?a product taken by mouth that contains a dietary ingredient intended to supplement or enhance the diet.? Dietary ingredients may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. In addition, dietary supplements can be extracts or concentrates, and may also be found in forms such as tablets, capsules, soft gels, gel caps, liquids, or powders. In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. DSHEA places dietary supplements in a special category under the general umbrella of "foods," thus FDA's Center for Food Safety and Applied Nutrition is responsible for the agency's oversight of these products and requires that every supplement be labeled a dietary supplement. Before DSHEA, dietary supplements were subject to the same regulatory requirements as were other foods. DSHEA stipulates that the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market, including monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. (The Federal Trade Commission regulates dietary supplement advertising.) While manufacturers are not required to register their dietary supplement products with the FDA before producing or selling them, each manufacturer is responsible for registering its production facility with FDA and for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label. For those manufacturers that require guidance either before the Small Entity Compliance Guide is released, or after (in interpreting the guide), it?s best to turn to a professional that understands what it takes to get a supplement to market and keep it there. --------------------------------------------------------------------- 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-supplement-manufacturers.shtml#get_code ..................................... 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