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  Shelf Life Statements on Dietary Supplements

May 22, 2008

The new Good Manufacturing Practice regulations for dietary supplements require that manufacturers with shelf life statements on their labels have appropriate scientific substantiation. However, expiration dates are not required by the rule, and the cGMPs released in June provide little to no guidance as to what qualifies as scientific substantiation. Manufacturers are left wondering whether it is in their best interest to provide a shelf life statement and, if so, what the appropriate testing programs are for substantiating shelf life – a daunting and difficult task for manufacturers and marketers of herbal products. 

To help manufacturers and marketers comply with GMPs, the American Herbal Products Association offers an information-packed tele-seminar, "Shelf Life Statements on Dietary Supplement Labels."

 

You’ll have a chance to gain regulatory, legal and scientific insight from these knowledgeable speakers:

 

¨      Anthony Young, Esq., general counsel to AHPA and a partner with the law firm Kleinfeld, Kaplan and Becker, LLP, Washington D.C. , will explore the dietary supplement cGMP implications of providing shelf life statements on dietary supplement products. Tony has practiced food, drug and environmental law since 1974. He advises and represents domestic and foreign suppliers, manufacturers and marketers and serves as AHPA General Counsel

 

¨      Michael McGuffin , president of AHPA, is the spokesman for the herbal products industry before state and federal agencies and has twice served on a working group and a subcommittee of FDA’s Food Advisory Committee. Michael’s presentation will address shelf life statements on dietary supplements from a regulatory and practical perspective.  Michael recently authored the association’s highly praised Annotated Final Rule on Dietary Supplement cGMP.

 

¨      Jeff Stassi, program manager for dietary supplement testing at Covance Laboratories, acts as a primary liaison for dietary supplement clients as well as providing expertise on designing comprehensive testing programs to meet scientific and regulatory requirements. He has over 22 years of experience in laboratory operations and client management and has set up testing programs for hundreds of clients within the dietary supplement supply chain. Jeff will address concerns and answer questions related to the execution and substantiation of stability studies.

Course materials include:

  • Audio file of the AHPA event
  • An unedited transcript of the AHPA event

  • Member Price: $220.00

    Non-Member Price: $520.00

       
 



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AHPA greatly appreciates the support of its sponsors, but acknowledgement of these companies is not an endorsement, recommendation, or warranty by AHPA of any company or its products or services, and AHPA has no responsibility for any transaction entered into with any of these companies.