AHPA NDI Database Unveiled at Member Meeting on March 17
(Silver Spring, MD) -- The American Herbal Products Association (AHPA) will feature a Forum on New Dietary Ingredients (NDIs) at its Annual Member Meeting on March 17, 2005, in Anaheim, California. The Forum will consist of a series of presentations that will explore issues that are raised when bringing new ingredients to market, and by FDA’s request for comments on the NDI notification process. In addition, AHPA and NPIcenter will introduce their jointly developed searchable database of existing NDI notifications.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) established that any ingredient that had not been marketed prior to its passage is a new dietary ingredient Filing of a pre-market notification with the Food and Drug Administration (FDA) at least 75 days prior to marketing is required for most of these new ingredients. These 75-day notifications must provide FDA with information that is the basis for the marketer’s conclusion that dietary supplements that contain the new ingredient will “reasonably be expected to be safe.” Over 250 NDI notifications have been filed since DSHEA became law more than ten years ago.
FDA recently increased its attention to new dietary ingredients with a request for comments last October and a public meeting a month later. AHPA has been active in providing comments, and AHPA President Michael McGuffin was a prominent speaker at FDA’s public meeting.
“There is a maze-like quality to FDA’s responses to these notifications and it is difficult to search all of the submissions that have been made in the past 10 years,” stated McGuffin. “The AHPA Forum on NDIs will provide guidance to AHPA members who are pioneering new dietary ingredients and need to know the realities and legalities of bringing these to market. And the AHPA NDI Database will provide a useful tool, minimizing the time and effort needed to review filed notifications.”
AHPA’s Membership Meeting will begin at 9 am on Thursday, March 17, at the Anaheim Convention Center, Room 304D. The AHPA Forum on NDIs is scheduled to begin at 10 am, and will include an FDA representative and several industry attorneys with experience in filing NDI notifications. The program will consist of:
Dr. Susan Walker, MD, Director, Division of Dietary Supplement Programs, US FDA – FDA’s dietary supplement initiative and NDI regulations.
Len Monheit, NPIcenter – Unveiling the AHPA NDI Database.
AHPA Member Attorneys Panel – Realities and Pitfalls of the NDI Notification Process:
Tony Young, Esq. (Kleinfeld, Kaplan & Becker) – FDA’s Responses to NDI Notifications – Searching for Consistency
Susan Brienza, Esq. (Patton Boggs LLP) – 3 tips: (1) Chemical ID First!; (2) Tell FDA a story; (3) Traditional use is not enough.
Holly Bayne, Esq. (Law Office of Holly Bayne) – How “chemical alteration” affects an ingredient's “new” status.
Marc Ullman, Esq. (Ullman, Shapiro & Ullman) – FDA’s implementation of the NDI rule can be used to support product innovation.
Q&A with Dr. Walker and Attorney Panel
Comments by Michael McGuffin
“As FDA continues to implement the NDI process, AHPA will maintain an active dialogue to ensure that FDA’s evolving interpretation of the law is sound, and in compliance with what was mandated by DSHEA,” said Beth Lambert, AHPA board chair and CEO of Herbalist and Alchemist. “AHPA members and the industry-at-large should follow the NDI issue closely since any modifications to the NDI regulations will have significant effect on how we all do business in the future.”
Both AHPA members and non-member companies are welcome to attend this important event. Advance registration (free for members; $25 for non-members) is required, and can be accomplished by completing and returning a registration form (http://www.ahpa.org/05_03_AHPA_Breakfast_Registration.pdf). Breakfast will be served at the beginning of meeting.
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers, and marketers of herbal products. AHPA's mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled, and sold.