Perspectives and issues relating to analytical methods and testing of dietary supplements http://npicommunity.com/Blogs/tabid/53/BlogId/8/Default.aspx en-US editor@npicenter.com sa@sa.sa Thu, 02 Jul 2009 22:15:47 GMT Thu, 02 Jul 2009 22:15:47 GMT http://backend.userland.com/rss Blog RSS Generator Version 3.1.20.17153 http://npicommunity.com/Blogs/tabid/53/EntryID/92/Default.aspx editor@npicenter.com http://npicommunity.com/Blogs/tabid/53/EntryID/92/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=92 Tue, 09 Oct 2007 15:19:00 GMT 2 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=92 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://npicommunity.com/Blogs/tabid/53/EntryID/85/Default.aspx editor@npicenter.com http://npicommunity.com/Blogs/tabid/53/EntryID/85/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=85 Sat, 30 Jun 2007 02:11:00 GMT 3 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=85 It was recently brought to my attention by a couple of my colleagues that they have learned some interesting facts about the stability and extraction efficiency of kavalactones. I am hoping they can elaborate on this in a posting so that others may benefit from their findings. http://npicommunity.com/Blogs/tabid/53/EntryID/78/Default.aspx editor@npicenter.com http://npicommunity.com/Blogs/tabid/53/EntryID/78/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=78 Wed, 20 Jun 2007 15:26:00 GMT 3 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=78 Many labs are now offering to test products for melamine but are not using the most current GC/MS method for melamine and related analogs that is required by FDA. It is important to make sure you use the correct method otherwise you will be wasting both your time and money. If you have a product that is being held up by the FDA automatic detention you also need to make sure you or the lab you are using is familiar with the specific FDA requirements on data submission to minimize the risk of getting the work rejected by the compliance officer. Details on the method can be found on the FDA website at www.fda.gov/cvm/GCMSscreen.htm. http://npicommunity.com/Blogs/tabid/53/EntryID/70/Default.aspx editor@npicenter.com http://npicommunity.com/Blogs/tabid/53/EntryID/70/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=70 Mon, 21 May 2007 07:43:00 GMT 1 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=70 Beware of any contract lab claiming they are a FDA "Approved" or "Certified" Lab. Contrary to what advertisements claim, FDA does not approve or certify labs. This is not to be confused with a lab claiming to be FDA "Registered" which actually does exist. Any lab can register with the FDA without passing any initial inspection or having any particular certification. The registration is for drug testing only and in no way implies the lab is qualified or has the expertise to test dietary supplements. http://npicommunity.com/Blogs/tabid/53/EntryID/61/Default.aspx editor@npicenter.com http://npicommunity.com/Blogs/tabid/53/EntryID/61/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=61 Sun, 25 Mar 2007 22:30:00 GMT 2 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=61 All parties interested in chondroitin and/or ORAC testing are welcome to attend the informal information session on Saturday March 10th between 11am and 1pm which will be held at Analytical Labs in Anaheim Inc.'s facility. The purpose of the meeting is to discuss the proposed AOAC Chondroitin method that recently underwent single laboratory validation (SLV) by Analytical Labs in Anaheim. This method will be undergoing an AOAC collaborative study shortly in the hopes that it will be adopted as an Official Method of Analysis. The co-study directors of the collaborative study, David Ji and Dr. Mark Roman, will be available during this time to answer any specific questions related to the chondroitin sulfate test method, and to explain the AOAC collaborative study process. In addition, Paula Brown (General Referee of the AOAC Dietary Supplements Methods Committee) of BC Institute of Technology will also be providing an update on the efforts between Canada and the US on the validation of a proposed ORAC method. Directions to the meeting can be found at: www.analytical-lab.com http://npicommunity.com/Blogs/tabid/53/EntryID/56/Default.aspx editor@npicenter.com http://npicommunity.com/Blogs/tabid/53/EntryID/56/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=56 Tue, 27 Feb 2007 19:21:00 GMT 0 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=56 The press surrounding the recent multivitamin review by Consumer Lab has generated a lot of questions that I feel are great examples of the misinformation about analytical issues we are trying to address in this forum. I would like to start by putting out to you the two main questions that immediately came to my mind after reading the report: 1) Why were USP specifications selected when even the FDA does not require dietary supplement companies to meet USP specs unless they are making a USP claim on their label? 2) What do the results of tests mandated in a USP monograph mean in terms of the “quality” of your product? http://npicommunity.com/Blogs/tabid/53/EntryID/53/Default.aspx editor@npicenter.com http://npicommunity.com/Blogs/tabid/53/EntryID/53/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=53 Tue, 30 Jan 2007 00:08:00 GMT 4 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=53 Thank you all for your wonderful comments and input regarding the enzymatic method and AOAC in general. The next question I would like to address is "Is this method an approved or official AOAC method?". The answer to this question is "no" and any lab claiming to be using an approved AOAC method is clearly in the dark as to what that means. I suppose it would be appropriate at this point to define what constitutes an "approved" AOACmethod. AOAC basically has two types of "approved" methods that pertain to our industry. The first AOAC approved method level is what is termed the "Peer Verified Method" (PVM). This is a method that has undergone a single-lab validation and its performance has been checked in at least one other, independent laboratory. It is expected (at least by AOAC) that most PVMs will eventually undergo full interlaboratory collaborative studies (usually 10-12 labs) and obtain "Official Method" status which is the second or highest level of approval. http://npicommunity.com/Blogs/tabid/53/EntryID/51/Default.aspx editor@npicenter.com http://npicommunity.com/Blogs/tabid/53/EntryID/51/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=51 Sun, 28 Jan 2007 04:16:00 GMT 6 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=51 The recent press release, "Single Lab Validation for Chondroitin Sulfate Completed" , has generated a lot of buzz in the dietary supplement community. Numerous questions regarding the method are being posed and it seems a forum for discussion is needed. To begin let us address the most frequently asked question, "Why did AOAC go with a different method from USP?" The USP publishes monographs, which are collection of methods (see http://www.usp.org/USPNF/), not just a single analytical method. The individual methods in the USP monographs are not intended to be used as "stand alone" methods and thus, individually are not suitable for determining the quality or purity of chondroitin. Unfortunately it is a common practice in the Dietary Supplement Industry, to employ the CPC analytical method while claiming to follow the USP. The problem with using only the CPC method is that it is "non-specific" and as such is not suitable for testing chondroitin levels in finished products containing other ingredients which can interfere with the test results. The current AOAC method was selected for its specificity to chondroitin and is suitable for use in assessing the quality of chondroitin as a single entity and within a product formulation. http://npicommunity.com/Blogs/tabid/53/EntryID/50/Default.aspx editor@npicenter.com http://npicommunity.com/Blogs/tabid/53/EntryID/50/Default.aspx#Comments http://npicommunity.com/Default.aspx?tabid=53&EntryID=50 Sun, 21 Jan 2007 19:58:00 GMT 3 http://npicommunity.com/DesktopModules/Blog/Trackback.aspx?id=50