With the long-awaited release by the by the Food and Drug Administration (FDA) on July 1 of its new dietary ingredients (NDI) guidance document, the American Herbal Products Association (AHPA) is hosting a webinar titled, "FDA's NDI Guidance: What It Means for Your Business," on Tuesday, July 19, from 1 - 3 p.m. EDST.
This webinar will address the implications to the dietary supplement and ingredients trade of the new guidance document and will review each of the controversial sections of the guidance to try to understand its potential impact—if it is not amended—on a variety of dietary ingredients and classes of ingredients.
Featuring former Food and Drug Administration (FDA) official Vasillos (Bill) Frankos, Ph.D., who has intimate knowledge of the agency's NDI guidance document as it was being developed, the AHPA webinar will also include a panel of industry legal experts (invited) who have collectively filed more than 30 NDI notifications with the agency within the last five years.
Other presenters include Anthony Young, Esq., of Kleinfeld, Kaplan & Becker and AHPA general counsel; and Michael McGuffin, AHPA president—who have a combined 40+ years of experience with dietary supplement legislative and regulatory issues.
This webinar is ideal for anyone who works for a company selling products in the dietary supplement industry or products covered by the Dietary Supplement Health and Education Act (DSHEA), including:
- Regulatory officers
- Product development and R&D personnel
- Compliance officers
- Business owners
- Quality assurance/quality control personnel
- General counsel/legal representatives
The AHPA webinar is unique among those being offered in that it is 100-percent focused on the supplements trade: all of the presenters currently work in industry, and participants will be able to interact with presenters and ask questions (ample time to be provided) in a free and open setting.
Questions to be answered at this industry-exclusive event: Is innovation dead? What are the new rules and how will they affect dietary supplement marketers? Can you keep marketing your best-selling ingredient? Is an ingredient "old" or "new" and why? What was FDA trying to accomplish with this guidance document? What are the opportunities for participants to amend the guidance?
"After receiving both industry and AHPA-member input, we have chosen to focus this webinar exclusively on the background leading up to the release of the document, a detailed review of the document itself, and, of course, its potential impact on the day-to-day business of dietary supplement and dietary ingredient marketers," noted McGuffin. "There are many provisions of the guidance document that are confusing and others that are troubling. This webinar will provide a solid foundation for companies to move forward in dealing with the implications of this historic document."
This AHPA webinar is presented with the support of and sponsored by Gradient, an environmental and risk science consulting firm renowned for its specialties in toxicology, epidemiology, risk assessment, product safety, contaminant fate and transport, and environmental/ forensic chemistry. Visit the Gradient website for more information.
For more information about and to register for the AHPA webinar, "FDA's NDI Guidance: What It Means for Your Business," 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.