Published: Thursday, 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: $50.00
Non-Member Price: $100.00
The Botanical Safety Handbook, Second Edition includes:
- Easily understood classification systems to indicate the safety of each listed species and the potential for drug interactions
- Information on adverse events reported in clinical trials or case reports
- Safety-related pharmacology and pharmacokinetics of each herb
- Additional information on the use of herbs by pregnant or lactating women
- Toxicological studies and data on toxic compounds
- Extensive references for each entry
The book is available in hardback print and online formats. Both versions contain the same information, but the online version, which is optimized for smartphones and tablets, has several additional attributes. Some of these relate to its operation, as it allows subscribers to search for keywords and botanical names and easily access the information they use most by saving personalized lists of entries. Perhaps more importantly, the online version will be updated regularly with new research, and subscribers will be notified of updates to provide immediate access to the most current information. The standard retail cost for either version is $119.95 (one-time cost in print; a renewable annual subscription online). We are discounting the cost for our members and would be happy to offer a discount to other organizations. A free preview of several entries are available online: