The U.S. Food and Drug Administration (FDA) posted its long-awaited guidance for new dietary ingredients (NDIs). The guidance, called "Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues," can be accessed by clicking on the above title.
A preliminary review of the guidance indicates that it is a combination of reinterpretation of certain elements of the existing law and specific suggestions to assist companies in providing the information needed to avoid having FDA identify concerns or objections to an NDI notification. American Herbal Products Association (AHPA) staff and counsel will be reviewing this guidance in greater detail over the next several days.
"Even though the guidance is not binding, we should all be concerned about any attempt by FDA to use this forum to change the rules and practices that have been accepted and in place for 17 years," commented Michael McGuffin, AHPA president. "At the same time, it appears that the agency has learned from the process of reviewing submitted notifications, and has described, for the first time, at least some of its expectations for the content of NDI notifications."
AHPA to Host NDI Educational Seminar
AHPA will host an educational seminar, "FDA's New NDI Guidance: What You Need to Know." This teleseminar will be scheduled within the next several weeks to ensure that adequate time is allowed to receive AHPA member input on FDA's new guidance. It will include a review of FDA's new teachings and will provide a step-by-step approach for successful submission of an NDI notification.
AHPA already has made available several excellent tools to assist in filing an NDI notification. These include:
- The AHPA NDI Database is a searchable online database of the over 575 NDI notifications that have been submitted to FDA to date. It is the only up-to-date compilation of NDI notifications available. This subscriber-based database provides access to the actual filed documents and also gives 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. For more information and to subscribe click here.
- AHPA's own Guidance for New Dietary Ingredient Notifications for Manufacturers and Distributors of New Dietary Ingredients was recently updated (in June 2011). It explains the NDI regulations, details what information to include—and exclude—in a notification and provides three hands-on worksheets. This will be revised again to include any new and relevant information from the FDA guidance. For more information click here.
About the American Herbal Products Association
The American Herbal Products Association is the national trade association for and the voice of the herbal products industry. AHPA is comprised of domestic and foreign companies doing business as growers, processors, manufacturers, and marketers of herbs and botanical and herbal products, including foods, dietary supplements, cosmetics, and non-prescription drugs. Founded in 1982, AHPA's mission is to promote the responsible commerce of herbal products. www.ahpa.org.