Perspectives and issues relating to analytical methods and testing of dietary supplements http://www.npicommunity.com/Blogs/tabid/53/BlogId/8/Default.aspx en-US editor@npicenter.com contactus@npicenter.com Fri, 25 Jul 2008 14:22:09 GMT Fri, 25 Jul 2008 14:22:09 GMT http://backend.userland.com/rss Blog RSS Generator Version 3.1.20.17153 I am happy to announce the publication of a SOP on Voucher Speciments in the journal of Analytical and Bioanalytical Chemistry that was funded by NIH. This project was a collaborative effort between several groups and hopefully the beginning of many more such informational articles for our industry. The key points I am hoping to convey to the industry is that this protocol was accepted and published in a "peer reviewed" journal which gives it substantial weight in the eyes of FDA. The passing of GMPs have created a huge business opportunity for the selling of chemical reference standards and botanical reference materials. Unfortunately there are no regulations or qualifications needed to sell these materials at least in the dietary supplement industry. What some companies are calling primary standards or botanical reference materials fail to meet the criteria that NIST, USP, NRC etc. have established as foundational to the development of such materials. There have been several incidents of compromised reference materials sold on the market which have affected us all in a very negative way. Once such example is chondroitin. The main company that people were buying reference material from had switched vendors and actually moved to a higher purity material than they had before. Unfortunately, due to a failure to properly characterize the material, this action resulted in substantial confusion when products suddenly failed to meet specification. Another example can be gained from the recent press release from Source One where they stated the leading supplier of tocotrienol standards had a 30% error in their reported purity. I feel that this is a very serious issue that could cause financial harm and legal liability to good companies trying to do the right thing. FDA's position is pretty clear: they expect standards to be properly qualified by valid, scientifically sound methods. FDA puts every standard they get through a whole battery of tests which the majority of companies from my experience (except for USP, NIST and NRC) fail to do. These companies are expecting that the suppliers they purchase standards and botanical reference materials from are doing due diligence which may not be the case. One point that is repeatedly emphasized in the new cGMP regulations is that all responsibility falls on the manufacturer for compliance with GMP regulations. They can't pass the blame to their standard supplier, contract lab or raw material supplier. The FDA holds the manufacturer fully accountable. Litigation and the FTC UCC is another story. However, a vigilant manufacturer can learn what questions to ask and what documentation to obtain when they are purchasing standards and botanical reference materials from suppliers. As a concerned supporter who really cares about the longevity of this industry, I encourage you all to protect yourselves from unqualified suppliers of standards and botanical reference materials. Let the science speak for itself and learn to question everything! If anyone is interested in getting a copy of the article please let me know. http://www.npicommunity.com/Blogs/tabid/53/EntryID/85/Default.aspx editor@npicenter.com http://www.npicommunity.com/Blogs/tabid/53/EntryID/85/Default.aspx#Comments http://www.npicommunity.com/Default.aspx?tabid=53&EntryID=85 Sat, 30 Jun 2007 02:11:00 GMT 0 http://www.npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=85