Legal experts with more than 30+ NDI-notifications submissions to discuss GRAS, synthetics, nanotechnology, and status determination.
The American Herbal Products Association's (AHPA) webinar titled, "FDA's NDI Guidance: What It Means for Your Business," is set for Tuesday, July 19, from 1 - 3 p.m. EDST.
This webinar, in response to the long-awaited release by the Food and Drug Administration (FDA) on July 1 of its new dietary ingredients (NDI) guidance document, 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.
Joining former FDA official Vasillos (Bill) Frankos, Ph.D., who has intimate knowledge of the agency's NDIs guidance document as it was being developed, is a panel of industry legal experts who have collectively filed more than 30+ NDI notifications with the agency:
Marc Ullman, Esq., Ullman, Shapiro & Ullman: "Probiotics & Nanotechnology"
Ashish Talati, Esq., Amin Talati: "Generally Recognized as Safe (GRAS) & NDI"
James Prochnow, Esq., Greenberg Traurig: Synthetics & What is a “Dietary Substance?”
Paul Rubin, Esq.: “NDI Status Determination: Marketing an Ingredient as a "Dietary Ingredient”
Other presenters include:
Anthony Young, Esq., of Kleinfeld, Kaplan & Becker and AHPA general counsel:
"Impact of NDI Guidance on Industry"
Michael McGuffin, AHPA president: "NDI Background & Timeline"
McGuffin and Young have a combined 40+ years of experience with dietary supplement legislative and regulatory issues.
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 the industry, and participants will be able to interact with presenters and ask questions (ample time to be provided) in a free and open setting.
"There are many provisions of the guidance document that are confusing and others that are troubling," noted McGuffin. "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 http://gradientcorp.com/index.php 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 https://connect.computility.com/form/index.php?id=563902d73f7ad60bfefaea9dbfeb11b0.
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.