Two additional options for viewing:
Original Event Time: SupplySide West 2011 - October 12th
Moderator: Jon Benninger, VP, Health & Nutrition Network, VIRGO
Duration: 3 hours
Own a copy of the full-length video taken from the Town Hall on the NDI Draft Guidance which drew an audience of more than 300 industry members. This draft guidance has significant implications for any company doing business in the U.S. dietary supplement industry, and the Town Hall captured a wide range of viewpoints, observations and recommendations. The event began with Sen. Orrin Hatch, longtime champion for consumer access to supplements, describing his concerns with the draft guidance and asking the industry to be active in its response. Following Sen. Hatch, Daniel Fabricant, Ph.D., Director of the Division of Dietary Supplement Programs at FDA discussed the details of the draft guidance. Fabricant echoed Sen. Hatch’s call for the industry to submit well-reasoned comments for the agency to consider. Audience members then heard from a panel that included the leadership of four leading trade associations. This joint presentation covered key parts of the draft guidance that the associations object to and will oppose in their official comments. Panelists included:
- Michael McGuffin, President, American Herbal Products Association (AHPA)
- John Gay, Executive Director and CEO, Natural Products Association (NPA)
- Steve Mister, President, Council for Responsible Nutrition (CRN)
- Harry Rice, Ph.D., Vice President of Scientific and Regulatory Affairs, United Natural Products Alliance (UNPA)
Key areas of concern expressed by the panel included:
- FDA’s restrictive definition of the term “dietary ingredient”
- FDA’s position on establishing that an ingredient is an “old dietary ingredient”
- FDA’s position that the manufacturer of the finished dietary supplement has the responsibility for filing NDI notifications
- The burden on industry and the FDA created by FDA’s interpretations
- FDA’s restrictive interpretation of “chemically altered” as it applies to manufacturing processes
- The impact on innovation that the draft guidance could have
- FDA’s restrictive views on the use of bio-identical synthetic botanical ingredients
- Whether the FDA’s position establishes an “approval” standard versus the “notification” standard described in DSHEA
Following the presentations, audience members participated in and open Town Hall forum with the speakers and participated in an open discussion with an industry panel that included:
- Melody Harwood, Director of Regulatory Affairs, AkerBiomarine
- Hame Persaud, Senior Vice President of Sales and Marketing, Sabinsa Corp.
- Jarrow Rogovin, President and Chairman of the Board, Jarrow Formulas