(June 21, 2007) — The American Herbal Products Association (AHPA) received an invitation from the Food and Drug Administration (FDA) this afternoon to attend a “stakeholder teleconference… to discuss a new food safety initiative.” Although the final rule on current good manufacturing practice (cGMP) for dietary supplements is not explicitly identified as the subject of the discussion, an accompanying phone number bears a message that identifies it as FDA’s Division of Dietary Supplements’ “cGMP final rule line.” Also, the FDA staff that will be present on the call include Dr. Robert Brackett, Director of the Center for Food Safety and Applied Nutrition, and Dr. Vasilios Frankos, Director of the Division of Dietary Supplements. AHPA therefore assumes that the topic of this teleconference is publication of the long-awaited final rule on dietary supplement cGMP.
The communication from FDA also noted that “resource material related to this teleconference” will be posted on the FDA website (www.fda.gov) by 11:30 am EDT. AHPA assumes that this material should include the final rule itself and encourages AHPA members to visit FDA’s website to review the rule. Note that this is likely to be formatted in a “prepublication” layout, which has been reported to run to over 1,000 pages. A more concise format will be made available when the rule is published in the Federal Register.
AHPA will provide additional and more detailed communications on this important topic tomorrow, and will promptly prepare a comparative document to identify all of the new requirements for manufacturing, packing and holding dietary ingredients and dietary supplements.
The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade -- comprised of the finest growers, processors, manufacturers and marketers of herbal products -- our mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbal products are manufactured, labeled, and sold. Website: www.ahpa.org.
Karen Robin, Director of Communications
American Herbal Products Association
Telephone: (301) 588-1171, x-107