WASHINGTON, D.C., December 12, 2013—The Council for Responsible Nutrition (CRN) and VIRGO Publishing today announced details for an industry-wide webinar, titled “NDIs Now: What You Need to Ensure Compliance,” designed to improve understanding of how companies can be in compliance with the new dietary ingredient (NDI) notification requirements under the Dietary Supplement Health and Education Act (DSHEA) even as industry waits for a re-issue of the draft guidance followed by final guidance. The webinar will take place Wednesday, Jan. 29, from 2:00 – 4:00 p.m. Eastern.
Key FDA official Daniel Fabricant, Ph.D., director of Dietary Supplement Programs, will address the agency’s current thinking on NDIs. In addition, a panel of former FDA regulators will provide additional perspectives. Other panel members include:
- Vasilios “Bill” Frankos, Ph.D., senior V.P. Global Product Science, Safety & Compliance, Herbalife (and former director of FDA’s Dietary Supplement Programs);
- Mitchell Cheeseman, Ph.D., managing director, Regulatory & Industry Affairs Department, Steptoe & Johnson LLP (and a former 20+ year official, FDA’s Foods Program); and
- Robert Martin, Ph.D., senior advisor for Food and Color Additive Safety, EAS Consulting (and former Deputy Director of FDA’s Division of Biotechnology and GRAS Notice Review).
CRN’s Duffy MacKay, N.D., vice president of Scientific and Regulatory Affairs, will moderate.
“FDA’s draft guidance on NDIs will be re-issued in 2014, followed by a stakeholder comment period and another window of time for FDA to publish final NDI guidance,” Dr. MacKay said. “A significant amount of time will pass before industry has final guidance. However, what many companies misunderstand is that even before the NDI guidance is final, there is still a requirement for NDI submissions under DSHEA. So how does our industry improve our track record in submitting NDIs, being compliant with the law, and not sacrificing ingredient innovation? Those are the things we want to address.”
This CRN/VIRGO webinar will cover the following questions to help responsible supplement industry companies address those issues:
- How do I determine whether an ingredient is “new” or “old”?
- What resources can I use to feel confident in this decision?
- If the ingredient is determined to be in the food supply prior to DSHEA (and thus “old”), is the particular form of the ingredient I am using chemically altered?
- If FDA has not objected to an NDI submission on an ingredient, but I am buying it from a different supplier—am I still covered?
- What if I have a new ingredient and I am prepared to invest in safety studies: should I focus my resources on obtaining generally recognized as safe (GRAS) status or submit an NDI notification?
The registration fee—$149 for CRN members and $199 for non-members—is a per registration site fee, so multiple people may participate in the webinar from a single site, such as a company’s conference room. This fee also includes unlimited access to the on-demand recording of the webinar for 90 days. Additional details and registration information are available at: www.crnusa.org/NDI0114.