WASHINGTON—FDA’s New Dietary Ingredient (NDI) Draft Guidance may not stand up in a court of law if finalized and enforced as is, suggested attorney Ashish Talati to an estimated audience of 250 participants during a recent webinar analyzing the controversial document. The Sept. 14 webinar was co-hosted by the Council for Responsible Nutrition (CRN) and VIRGO, and is now available for a limited time for purchase on-demand.
Talati said the Draft Guidance may not withstand judicial review under an established legal test for review of agency actions that he believes undercuts FDA’s position.
CRN’s Duffy MacKay, N.D., moderated the webinar which included four speakers: FDA’s Daniel Fabricant, Ph.D., director, Division of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition (CFSAN); FDA’s Dan Levy, Ph.D., supervisor, New Dietary Ingredient Review Team, Division of Dietary Supplement Programs, CFSAN; James E. Hoadley, Ph.D., senior consultant, EAS Consulting Group and a 20-year FDA veteran; and Talati, J.D., M.S., RAC, partner, Amin Talati.
The two FDA officials provided an overview of the draft guidance, discussed FDA’s reasoning and rationale for the draft guidance, and explained the process the agency goes through during NDI notification reviews. Hoadley offered his best practices for submitting NDI Notifications.
“Our industry requested an NDI Draft Guidance from FDA to help clarify the law and level the playing field; however, this Draft Guidance overreaches and attempts to perform an end run around the original intent of the Dietary Supplement Health and Education Act," MacKay said. “We hope FDA is serious about listening to industry concerns about the document and will moderate its interpretation to incorporate many of our concerns about the legal requirements for NDIs."
The two-hour webinar is available for purchase on-demand until Dec. 21 ($149 for CRN members; $199 for non-members). A pre-recorded bonus hour with a panel of legal experts—Michelle C. Jackson, associate, Venable, LLP; Sarah Roller, J.D., R.D., M.P.H., partner, Kelley Drye, LLP; Ashish Talati, J.D., M.S., RAC, partner, Amin Talati, LLC; Steve Mister, Esq., president and CEO, CRN—can also be purchased with the webinar at an additional cost of $99.
In addition to the webinar, VIRGO will hold a town hall discussion on the topic at its annual trade show Supply Side West, which will be held Oct. 10 to 14 in Las Vegas. CRN will hold a wrap-up session at The Conference, “NDIs—What’s Our Next Move?" to explore next steps. The Conference will be held in Rancho Palos Verdes, Calif., October 19 to 22 at the Terranea Resort.
