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Monday, November 29, 2010

Identity & Quality Testing for Dietary Supplement GMP Compliance

I hope that you have been well.  The FDA remains busy and last month I attended a conference that included a session on FDA enforcement and compliance for dietary supplements.  The speakers included Jennifer Thomas, acting director, Office of Compliance, CFSAN, US FDA; Ralph Tyler, chief counsel, Office of Compliance, US FDA and Eugene Thirolf, JD, director, The Office of Consumer Litigation, US Department of Justice, whose office prosecutes cases developed by FDA.
Two very interesting comments were made by Ms. Thomas:  First she noted that FDA plans to bring enforcement activities against dietary supplement manufacturers who use aseptic processing methods but are not properly registered.  This means companies that make liquid and gel form supplements in hermetically sealed containers.  Such operations must be registered with FDA’s office for Low-Acid and Acidified Canned Foods (  The name of this office may have lead many such producers to think the regulations did not pertain to them.  We have recently helped a company file the proper paperwork and we can help you too if needed.
The second very interesting comment by Ms. Thomas was, “…and don’t even think about using the word antioxidant on the label.”  During the question and answer period I asked Ms. Thomas what that comment meant.  She admitted to using a bit of hyperbole but went on to explain that FDA is adamant that only Vitamins A, C & E and the mineral Selenium (ACES) are antioxidants and that the agency would be cracking down on antioxidant claims used for other nutrients. Many of you have had conversations with me on this very topic.  I think it will literally take an act of Congress to get nutrients other than ACES recognized as antioxidants—so write your Congressmen!

My assistants and I continue to monitor FDA warning letters—many recent ones cite dietary supplement companies for failing to do testing to confirm the identity of the ingredients they are using. Don’t let this happen to you. To learn about identity testing you may wish to ‘attend’ the free webinar from Natural Product Insider:

Establishing Identity and Quality Testing Programs for Compliance with the Dietary Supplement cGMPs

Tuesday, December 14, 2010 at 2:00 PM EST

Companies that manufacture and distributed dietary supplements in the U.S. must now comply with final FDA current good manufacturing practices (cGMPs) related to the identity, purity, strength and composition of products. However, FDA’s initial inspections have found serious problems related to testing and documentation. During this Webinar, learn from the experts on how to improve approaches to identity and quality testing for GMP compliance. FDA’s Carl Reynolds will discuss component regulatory specifications and provide an overview of FDA expectation regarding this aspect of cGMP compliance; Frank Jaksch will discuss the importance of authenticated reference standards for identity testing; and Cynthia Kradjel will discuss how to develop FTNIR methods that are fit for purpose.

As the end of year approaches we at Bioscience Translation & Application stand ready to help you meet your 2010 project goals.  Contact us today for help with FDA compliance questions on foods, dietary supplements, cosmetics and over the counter drugs. Visit us at

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