American Herbal Products Association (AHPA) President Michael McGuffin, General Counsel Anthony Young (Kleinfeld, Kaplan & Becker) and Chief Operating Officer Devon Powell will deliver must-see presentations during the 2010 SupplySide East conference and trade show April 26-28 in Secaucus, N.J.
On April 27 from 11:00 to 11:50 a.m., McGuffin will discuss the process the Food and Drug Administration (FDA) uses to evaluate Adverse Event Reports (AERs) it receives* and provide data on the numbers and types of AERs submitted to FDA on dietary supplements. McGuffin will also review obligations of marketers of dietary supplements when they receive AERs associated with their products.
Also on April 27, Powell moderates “Ingredient Supplier Qualification and GMP Compliance: Development of a New Certificate of Analysis (COA) Guideline” from 10:00 to 10:50 a.m. During the session, Scott Rosenbush of AHPA member-company P.L. Thomas and Nutrilite’s Amy Caplette will discuss a voluntary Certificate of Analysis (COA) Guideline newly developed by industry trade groups: American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN) and Natural Products Association (NPA). The intent of the new guideline is to serve as a guide to the type and scope of information that should appear on a COA for a component or ingredient for use in the manufacture of a dietary supplement.
Finally, top off the show with AHPA’s Young and Marc Ullman (Ullman Shapiro & Ullman) as they present “Is FDA Spoiling the Liquid Supplement and Conventional Beverage Segment?” on April 28 from 9:00 to 9:50 a.m. Attend this session to hear Young discuss the FDA's draft guidance for conventional foods, and how the guidance may be seeking to put the brakes on structure/function and ingredient content claims for beverages. “Important regulatory wisdom for those who are in these segments or who are contemplating entry into these segments will be provided,” Young assures.
More information on these SupplySide East educational offerings is available online. To view recent presentations by AHPA staff, please visit the AHPA Web site.
* AHPA members see the AHPA Update of Jan. 22, 2010 for information on obtaining your complimentary copy of McGuffin and Young’s report of a Dec. 10 FDA meeting on the agency’s review policy for evaluating dietary supplement AERs, including serious adverse event reports (SAERs).
The American Herbal Products Association (AHPA) is the national trade association and 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 herbal products, including foods, dietary supplements, cosmetics, and nonprescription drugs. Founded in 1982, AHPA’s mission is to promote the responsible commerce of herbal products. Website: www.ahpa.org.