Mr. Shaw: “The Natural Products Association is pleased with the FDA’s commitment to an open dialogue with NPA members and the industry about the NDI draft guidance. Our supplemental comments filed today are intended to ensure the safety of consumers and provide clarity to the industry, without imposing unreasonable or unnecessary regulatory barriers to the marketing of new products.
All of us at NPA look forward to a substantially re-written draft guidance from the FDA. We need to find a solution that works for both the FDA and the industry. I’d like to thank the FDA for taking our concerns seriously, and to our members for their ongoing input and support. We look forward to discussing these issues further with the FDA.”
Dr. Welch: “NPA’s supplemental comments address three key points in the current draft guidance. First, the draft guidance should make clear that a synthetic copy of a constituent or extract of a botanical can be a dietary ingredient. Legislation previously passed by Congress mandates that synthetic and natural ingredients for vitamins cannot be differentiated since our bodies treat the synthetic version the same way as the natural version. Simply put, there is no basis for the different treatment of botanicals under the law.
Second, the draft guidance should provide criteria for identifying a “chemically altered” ingredient. NPA believes that a better approach would be to provide objective, analytically-based criteria for the industry.
Finally, the draft guidance should eliminate the need for unnecessary duplicate filings of the same NDI. The FDA should revise the draft to expressly permit filing of an NDI master file, and acknowledge that an NDI notification may incorporate by reference any information already submitted to the FDA. We believe these changes will lead to a better draft guidance for consumers, industry and the FDA.”