“No Way” FDA Can Require NDI Notifications For All Supplements – McGuffin
This article was originally published in The Tan Sheet
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The leader of the American Herbal Products Association is confident FDA will ultimately require notifications strictly for new dietary ingredients, not all supplements containing those ingredients. “There is no way that enforceable, final guidance requires every downstream finished product to file an NDI notification or be subject to enforcement action,” Michael McGuffin said Sept. 8 at AHPA’s NDI Congress in Chicago. This is the most important issue with the draft guidance, he said. “We will build not only opinions but also a strong legal argument as to why that’s inaccurate,” he added. McGuffin said that in a 1997 guideline FDA defined when NDI notifications are required under the Dietary Supplement Health and Education Act.
The guideline “very clearly says the manufacturer or distributor of the dietary supplement or of the ingredient” may file the notification, he said. Another speaker, Jim Prochnow, a partner at Greenberg Traurig, said firms should refer to the language of the law in comments on the draft guidance. “We have to go back and actually look at the statute,” Prochnow said. FDA’s assertion that NDI notifications are required for all products with new ingredients has been among industry’s main concerns since the guidance was released (Also see "NDI Guidance Sparks Questions Even From Firms Ready To Comply" - Pink Sheet, 18 Jul, 2011.). McGuffin said the two interim NDI notification guidelines AHPA released while awaiting FDA’s guidance are “more precisely honest to the law.” The trade group’s guidelines recommend firms say they are filing for an NDI to be used in any new supplements that contain legal ingredients and are produced under current good manufacturing practices. “We need to be careful and we need to continue to train the industry if we can establish that as a practice,” he added. Input From Ingredient Suppliers Needed There was broad agreement among speakers that more input is needed from ingredient suppliers, not just from finished product manufacturers. More involvement from ingredient suppliers is important, they said, because it makes more sense for suppliers to file notifications. “It’s the supplement marketers who have expressed the most anxiety on this because they feel the burden’s been shifted,” McGuffin said. “We need the ingredient companies here.” Ingredient firms should file NDI notifications and then spread their costs across finished product manufacturers that purchase the ingredients, said Alan Feldstein, an attorney of counsel to Collins, McDonald & Gann. “That would be a much more efficient approach to this whole situation,” he said. “It gives FDA what they want as far as safety issues, and it gives the industry what it needs, which is the ability to conduct its business with the ingredients that have a reasonable expectation of safety,” Feldstein said. He said it is important to raise questions about when NDI notifications are required and other elements of the guidance. “FDA sometimes loses sight of the fact” that although its rules are in place to protect consumers, “from a practical, ‘how-does-the-world-work’ standpoint, it does not always work that way,” Feldstein said. The deadline for comments is Dec. 2. |