Webinar to Address How to Balance Current NDI Compliance with

For Immediate Release
Contact: Gretchen Powers, 202-204-7682
Ana Wilbert, 202-204-7665
Webinar to Address How to Balance Current NDI Compliance with
Ingredient Innovation as Industry Awaits Final Guidance Document
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the draft guidance followed by final guidance.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“FDA’s draft guidance on NDIs will be re-issued in 2014, followed by a stakeholder comment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.”
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Webinar To Address NDI Compliance
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This CRN/VIRGO webinar will cover the following questions to help responsible supplement
industry companies address those issues:
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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.
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Note to Editor: The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade
association representing 100+ dietary supplement manufacturers, ingredient suppliers, and companies providing services to
those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary
supplements in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members
also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit www.crnusa.org and
www.lifesupplemented.org. Follow us on Twitter @crn_supplements and @wannabewell, Facebook, Google+, and Vine.