American Herbal Products Association Educational Tele-Seminar Events present:
Navigating FDA’s New Dietary Ingredient (NDI) Notification Requirement
When: Friday, May 19, 2006, at 1pmET
Where: Your telephone
Cost: $195 members, $495 non-members
What: You Will Learn How to File an NDI – Success & Risks of Rejection
(Silver Spring, MD, April 10, 2006) -- The American Herbal Products Association's upcoming NDI tele-seminar will bring together authority lawyers and scientists with substantial experience in NDI notifications to FDA. They will discuss their experiences with the FDA NDI process, the need for precision in submissions, and the need carefully to communicate about the ingredient with FDA.
- Did you know that manufacturers must notify FDA and provide safety substantiation 75 days in advance of marketing dietary ingredients introduced after October 15, 1994? Those ingredients are called New Dietary Ingredients (NDI).
- Did you know that an NDI — or product containing an NDI — that has not gone through the notification process is adulterated?
- Did you know that adulterated products are unlawful and subject to FDA seizure, injunction against sale, and that companies and their officers marketing such products are subject to criminal prosecution? (Or as Tony Young, AHPA’s General Counsel, would say, “How would your company’s officers look in orange jumpsuits?”)
- Did you know that a selling a product containing an unlawful NDI may invalidate your product liability insurance? (As in, “You're on your own.”)
- Michael McGuffin , AHPA’s President, will describe AHPA’s recently launched NDI database that provides detailed analysis of NDI notifications as well as links to all of the FDA files containing those notifications.
- Anthony Young, Esq, of Kleinfeld, Kaplan & Becker LLP, and AHPA’s General Counsel, will define an NDI and outline what's at stake for your company in today’s regulatory climate as with respect to the sale and use of NDIs. Mr. Young and his partners have been involved in more than ten NDI notifications to FDA. He will detail what filing without comment means, as well as the meaning of a negative response from FDA. And he will describe how manufacturers and suppliers can address the NDI requirement.
- Marc S. Ullman, Esq, of Ullman, Shapiro and Ullman, will provide insight into the FDA NDI review process and describe the common mistakes submitters make and how FDA seems to go out of its way not to approve NDIs. He will also catalog the limitations FDA has imposed and is now imposing on NDIs, even those that are filed without comment.
- Guest Industry Specialist, will discuss the types of safety substantiation that FDA has found to be adequate to allow an NDI notification to be accepted without comment.
The registration form can be downloaded from the AHPA Website at the following link: http://www.ahpa.org/06_05_AHPA_NDI_TeleSeminar.pdf. Please fax your completed form to: 301-588-1174. Advance registration only; the deadline is May 15, 2006. Once registered, a confirmation email will be sent to you within one week. In addition, all pertinent materials and instructions will be sent by email prior to the event. If you have any questions, please contact Robin Gellman at [email protected] or 301-588-1171, x106.
The session begins at 1:00 pm ET / 12:00 noon CT / 11:00 am MT / 10:00 am PT and runs for two hours. The cost of participation is $195 (AHPA Members) / $495 (non-members) per connection. The cost includes an unedited transcript and a Certification of Completion, an important addition to cGMP compliance training and personnel files; additional certificates cost $25 each. An MP3 audio file will be available for an additional $25.
AHPA’s tele-seminars are a convenient and cost-effective way to explore issues, gain insight and enhance knowledge important to your herbal and dietary supplement business. The tele-seminar is a live telephone conference call. Please note, the registration fee is charged per phone connection, but as many staff members as you wish may participate by speaker phone.
To facilitate freedom to raise difficult issues, participants may email questions regarding the subject matter of the conference that will be read in an anonymous fashion during the Q&A session. If you have questions for the panel in advance of the event, please email them to Robin Gellman: [email protected], and she will pass them along to the participants who will answer your questions during the “Q & A” session of the event.
The American Herbal Products Association (AHPA) is the only national trade association devoted solely to herbal issues. Representing the core of the botanical trade -- 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 quality with respect to the way herbs are manufactured, labeled, and sold. Website: www.ahpa.org.