Session F5: Room S501-cd (McCormick Place - Chicago) | ||
Sunday AMFORUM: Proposed Current Good Manufacturing Practices (CGMP) for the dietary supplement industry | ||
| Moderator(s): | R. H. Meer, Engineering & Management Consultants (EMC) | |
| Panelist(s): | K. A. Weaver, Weaver & Amin J. F. Cassens, Cassens Consulting R. Kapoor, Bioriginal Food & Science Corp. J. M. Roza, NOW Foods | |
| Time: | 9:00 AM | |
| On March 7, 2003, the FDA issued its 540-page document on Current Good Manufacturing Practices (CGMP) for the dietary supplement industry. The proposed rulings identify some of the troubling issues associated with dietary supplements like over or under assay of active components, adulteration and product contamination. The FDA will now require manufacturers to maintain very specific records relating to CGMP standards not previously mandated. The announcement provides for a 90-day comment period before FDA reviews these rules again before implementation within one year following their second review. This forum will present the proposed CGMP rulings the industry was asked to respond. The moderator will first discuss an overview of the CGMP rulings, their purpose, and introduce the other forum members. He will then present the FDA’s nine comprehensive questions. For example, the FDA may require specific defect action levels (DALs) of all nutraceuticals? The FDA wants manufacturers of functional foods to document procedures not currently required of food manufacturers. Next, a natural products attorney will discuss the legal aspects of the CGMP proposal. He will review the possible penalties that IFT members will become subjected. Furthermore, how will the CGMP rules for the dietary supplement industry be different from the food industry CGMP? Firms most affected by the CGMP proposals include ingredient manufacturers for the functional food and nutraceutical fields who will provide their view on the new regulations. The moderator will still add a manufacturer to the forum panel to complete the array of affected firms. To complete the panel, a marketing consultant will present his views an expected market reaction to these proposed rules by retailers and the public in general. The forum will then be opened allow questions of the panel and to provide a lively interaction of ideas. | ||