Trade groups line up NDI draft guidance reviews

Related tags Dietary supplement Ndi

Leading dietary supplement trade associations are lining up to help industry understand the Food and Drug Administration’s draft guidance for new dietary ingredients (NDI) and the potential implications.

The American Herbal Products Association (AHPA), the United Natural Products Alliance (UNPA), the Council for Responsible Nutrition (CRN) are all planning to run events, physical or virtual, to help industry get to grips with the new guidance.

The Natural Products Association (NPA) yesterday hosted the webinar, NDI Guidance: What You Need to Know​, involving the association’s Dr Cara Welch and John Gay. The other speakers were Dr Daniel Fabricant​, director of the Division of Dietary Supplement Programs at FDA and Scott Bass, head of the Global Life Sciences Team at Sidley Austin LLP. Our coverage of the webinar can be found here: Lawyer: FDA line on grandfathered ingredients was not made clear​.

Next up is the AHPA Seminar, ‘FDA's NDI Guidance: What it Means for Your Business‘,​which is ​slated for July 19, 2011 from 1 to 3pm ET. Michael McGuffin, president of AHPA, will be joined by former FDA-CFSAN director Vasilios (Bill) Frankos​, PhD (now with Herbalife), Tony Young, Esq, from Kleinfeld, Kaplan & Becker and AHPA General Counsel, and an expert panel of experienced attorneys.

UNPA will host an intensive two-day seminar, NDI Guidance: Understanding the new safety paradigm​, on July 26-27 in Salt Lake City to review the NDI guidance and explore the critical issues, new challenges and opportunities. Dr Fabricant has been invited as the event’s keynote speaker. The seminar will also feature expert speakers on toxicology and the GRAS affirmation process.

CRN will host the webinar, FDA’s NDI Guidance Document and Its Impact on the Dietary Supplement Industry, on Wednesday, September 14, 2:00 – 4:00 p.m. EDT. CRN’s Duffy MacKay, ND, vice president, scientific and regulatory affairs, will moderate the event, and is set to be joined by Dr Fabricant (invited); Dan Levy, FDA (invited); Ashish Talati, JD, MS, RAC, partner, Amin Talati, LLC, and James Hoadley, PhD, senior consultant, EAS Consulting Group, LLC.

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