(Silver Spring, MD, May 12, 2006) -- This week’s tele-seminar, Navigating FDA’s New Dietary Ingredient Notification Requirements, will premiere the American Herbal Product Association's new Interim Guidance for New Dietary Ingredient Notifications for Manufacturers or Distributors of New Dietary Ingredients. This highly valuable “A-Z how-to” document explains the federal new dietary ingredient (NDI) regulations, details what information to include (and exclude) in a notification, and provides three practical hands-on worksheets:
- Determination of Requirement to Submit
- Submission of NDI Notification
- Cover Letter Template for Notification Submission
In addition to this and other resource documents, tele-seminar registrants will receive a $50 discount on the annual subscription for the AHPA NDI Database, which will be demonstrated at the tele-seminar. The AHPA NDI Database does most of the hard work for your company. It easily locates individual NDI notifications by searching for such key terms as the ingredient generic name, brand name, and (in the case of botanicals) Latin name of all NDIs posted by FDA, as well as the name of the submitting firm, their counsel or other consultant, and the FDA report number. Further, AHPA’s “outcome statement” for each notification succinctly summarizes FDA’s response. It also provides direct links to the available documents in each notification. With the discount subscription fees would drop from $125/year to $75/year for AHPA members, $495/year to $445/year for non-members (details at: http://ndi.npicenter.com/).
All herbal and dietary supplement companies must understand the NDI Notification requirement. You must be sure that the ingredients in your products are lawful, and not NDIs that have never been filed with FDA. If your products include ingredients that came on the market after DSHEA was passed in 1994, you may have a serious problem. Learn how to comply with FDA’s NDI requirements, and the business risks you are taking by not knowing if your products are in compliance, or for not complying. Sign-up today for this enlightening, convenient, and economical AHPA tele-seminar!
Benefit from Our Experts’ Guidance:
- Michael McGuffin, AHPA president, will describe the AHPA 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, what “filing without comment” means, the meaning of a negative response from FDA, and more.
- Marc S. Ullman, Esq, of Ullman, Shapiro and Ullman, will provide insight into the FDA NDI review process and describe common mistakes by submitters, how FDA seems to try not to approve NDIs, and FDA limitations on NDIs, even those that are filed “without comment.”
- James T. Heimbach, PhD, FACN of JHeimbach Food and Nutrition Consulting, will discuss the types of safety substantiation that FDA has found to be adequate to allow an NDI notification to be accepted without FDA comment.
Plus – you’ll get a chance to submit your own questions to the experts prior to and during the Q&A session.
When: Friday, May 19, 2006, at 1pmET – 3pmET
Where: Your telephone or office conference room
Cost: $195 per listening site for members (no matter how many people are in the room) / $495 per listening site for non-members
Goal: Learn how to file an NDI: how to succeed, rejection risk factors
Registration: fax-back form online: http://www.ahpa.org/Portals/0/pdfs/06_05_AHPA_NDI_TeleSeminar.pdf
The session begins at 1:00 pm ET / 12:00 noon CT / 11:00 am MT / 10:00 am PT and lasts 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 or CD will be available for an additional $25.
Advance registration only; the deadline is Monday, May 15. Once registered, a confirmation email will be sent to you within two days and all support resources developed specifically for this tele-seminar and instructions will be sent by email 48 hours prior to the event. If you have any questions, please contact Robin Gellman at [email protected], or 301-588-1171, x106.
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 listen in on your speaker phone.
The American Herbal Products Association (AHPA) represents 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.