So Very Important to Save Our Supplements
Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), who authored the Dietary Supplement Health and Education Act (DSHEA) in 1994, have recently contacted the FDA opposing its NDI draft guidance. The FDA’s New Dietary Ingredients (NDI) draft guidance deviates from the senators’ intent when they wrote the DSHEA. Within the last month the senators had sent a letter to the FDA calling for it to immediately withdraw the NDI draft guidance, and they have requested a meeting with the FDA in which they would discuss rewriting the draft. They have yet to receive a response from the FDA.
Main Concerns in the NDI Draft Guidance:
The main problem with the draft guidance is the new requirement by the FDA that filings for NDIs be filed on each finished product, not only on ingredients. The senators rightly assert that this would only serve to burden manufacturers with additional costs and that the new requirements would not yield safer products.
Many other industry leaders have also called for the FDA to create a new draft guidance, and pressure continues to build on this issue. Industry leaders are hopeful that Hatch and Harkin’s remarks will influence the FDA since, as the main authors of the DSHEA, their comments are expected to carry more weight. The draft guidance clearly deviates from the senators’ intentions and they are making efforts to have the FDA correct the problematic areas. Still, some believe that it is probable that the FDA will not offer any response to the senators’ request.