07.01.13
Two leading experts from the Natural Products Association (NPA), Washington, D.C., participated in a panel session discussing key regulatory issues at the 16th Annual FDA-OCRA Educational Conference in June. Cara Welch, PhD, senior vice president of scientific and regulatory affairs, and Vicki Whitsitt, scientific and regulatory affairs manager, joined Daniel Fabricant, PhD, director of the division of dietary supplement programs for FDA, and Michael McGuffin, president of the American Herbal Products Association, during the session, “CFSAN and Industry Update.”
The session featured an update from FDA about industry hot topics, including the agency’s current regulatory priorities. In addition, the experts from the two industry associations addressed the challenges facing dietary supplement companies both on Capitol Hill and on the regulatory front. While Good Manufacturing Practices (GMPs) continue to be at the forefront of FDA activities, it’s not just about GMPs—speakers touched on topics such as Adverse Event Reporting (AER), the draft New Dietary Ingredient (NDI) guidance, proposed rules under the Food Safety Modernization Act (FSMA), imports/exports of supplement ingredients, the challenge of adulterated ingredients and more.
The FDA-OCRA Educational Conference is an educational conference co-sponsored by FDA to promote interaction between Los Angeles area professionals and Washington, D.C.-based FDA personnel.
The session featured an update from FDA about industry hot topics, including the agency’s current regulatory priorities. In addition, the experts from the two industry associations addressed the challenges facing dietary supplement companies both on Capitol Hill and on the regulatory front. While Good Manufacturing Practices (GMPs) continue to be at the forefront of FDA activities, it’s not just about GMPs—speakers touched on topics such as Adverse Event Reporting (AER), the draft New Dietary Ingredient (NDI) guidance, proposed rules under the Food Safety Modernization Act (FSMA), imports/exports of supplement ingredients, the challenge of adulterated ingredients and more.
The FDA-OCRA Educational Conference is an educational conference co-sponsored by FDA to promote interaction between Los Angeles area professionals and Washington, D.C.-based FDA personnel.