07.26.11
The American Herbal Products Association has updated and relaunched two important resources for dietary supplement companies that include new dietary ingredients (NDIs) in their products. The newly revised AHPA NDI Database and the AHPA Notifications Submissions Package are designed to assist companies that intend to sell an NDI or a dietary supplement that contains an NDI. These companies must first submit a notification to FDA that includes information that is the basis for the company's conclusion that the dietary supplement will "reasonably be expected to be safe." With more than 575 entries, the AHPA NDI Database provides access to and understanding of notifications submitted to FDA for new NDIs that are used in dietary supplements. This subscriber-based database also provides a concise "outcome statement" for each NDI file that quickly summarizes how FDA has responded to every notification, and the problems—if any—that the agency identified for each. As part of the database subscription, subscribers will be notified by e-mail when additions are made to the AHPA NDI Database.
The AHPA NDI Notifications Submissions Package contains the tools needed to navigate FDA's NDI notification requirements: a 40-page Guidance for New Dietary Ingredient Notifications for Manufacturers and Distributors of New Dietary Ingredients (updated June 2011) explains the NDI regulations, details what information to include, and exclude, in a notification, and provides three hands-on worksheets; the transcript and audio file of an AHPA-sponsored teleseminar conducted by industry legal, nutrition and regulatory experts; a Macromedia flash tour and demonstration of the AHPA NDI Database; and a Food and Drug Law Journal article by Michael McGuffin, AHPA president, and Anthony Young, AHPA general counsel, titled, "Premarket Notifications of New Dietary Ingredients: A Ten-Year Review.” For further information: www.ahpa.org
The AHPA NDI Notifications Submissions Package contains the tools needed to navigate FDA's NDI notification requirements: a 40-page Guidance for New Dietary Ingredient Notifications for Manufacturers and Distributors of New Dietary Ingredients (updated June 2011) explains the NDI regulations, details what information to include, and exclude, in a notification, and provides three hands-on worksheets; the transcript and audio file of an AHPA-sponsored teleseminar conducted by industry legal, nutrition and regulatory experts; a Macromedia flash tour and demonstration of the AHPA NDI Database; and a Food and Drug Law Journal article by Michael McGuffin, AHPA president, and Anthony Young, AHPA general counsel, titled, "Premarket Notifications of New Dietary Ingredients: A Ten-Year Review.” For further information: www.ahpa.org