WASHINGTON — The New Dietary Ingredient draft guidance, which recently was issued by the Food and Drug Administration, is causing a stir within the dietary supplement industry as experts continue to evaluate what kind of impact the guidance will have on their businesses.
An attorney panelist at a recent industry-sponsored webinar suggested the draft guidance may not stand up in a court of law if finalized and enforced as is.
CRN’s Duffy MacKay, VP scientific and regulatory affairs, moderated the webinar, which included four speakers: FDA’s Daniel Fabricant, director of the Division of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition; FDA’s Dan Levy, supervisor for the New Dietary Ingredient Review Team, Division of Dietary Supplement Programs, CFSAN; James E. Hoadley, senior consultant at EAS Consulting Group; and Ashish Talati, partner at 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The two FDA officials provided an overview of the draft guidance, discussed FDA’s reasoning and rationale for the draft guidance, and explained the process the agency goes through during New Dietary Ingredient Notification reviews. Hoadley offered his best practices for submitting NDI notifications, and Talati shared his legal perspective of the draft guidance, including his opinion that the draft guidance may not withstand judicial review; specifically referencing an established legal test for review of agency actions that he believes undercuts FDA’s position.
"Our industry requested an NDI draft guidance from FDA to help clarify the law and level the playing field; however, this draft guidance overreaches and attempts to perform an end run around the original intent of the Dietary Supplement Health and Education Act," MacKay said.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 that 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 Sept. 14 webinar was co-hosted by the Council for Responsible Nutrition and VIRGO, and is available through Dec. 21 for purchase on-demand, CRN stated.
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 October 10-14 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 19-22 at the Terranea Resort.
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