Some insight and clarification offered from FDA but many questions left unanswered

The Natural Products Association hosted a Webinar featuring both an audio and video conference in the form of a slide show presentation. The Webinar featured two speakers, Dr. Daniel Fabricant, director of the Division of Dietary Supplement Programs at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and Scott Bass, head of the Global Life Sciences Team at Sidley Austin LLP, followed by a Question and Answer segment. Dr. Fabricant began by providing an overview of the document as well as FDA’s position and thought process in preparing the draft guidance. Scott Bass then briefly presented his initial impressions based on his experience with the drafting and implementation of DSHEA. He also offered his interpretation of how this document will affect industry and some feedback that he has gathered from industry.

While Dr. Fabricant did not offer much clarification with respect to many of the questions posed by Bass and the teleconference participants during the Q & A segment, he should be commended for his efforts to address the barrage the of questions he received as the representative of FDA.

Unfortunately, my initial impression is that while I think it is critical that industry submit organized, well prepared comments to FDA highlighting the aspects of the guidance document that, if enforced, would have a devastating affect on industry, small businesses and consumer access to the dietary supplements they have grown accustomed to using, I’m not sure that FDA intends to do much, if any revisions to the guidance document, short of clarifying certain segments.

Several very good questions were posed by call participants as well as Scott Bass, such as how FDA intends to manage and respond to the potential flood of new NDI notifications that it may receive as a result of this guidance, to which Dr. Fabricant indicated that he did not anticipate that FDA would have any problems responding within the 75-day period. He also did not offer much clarification on the issue of a submission not being “complete” and therefore not triggering the 75 day clock, until FDA indicates the submission is complete, which could mean that relatively minor administrative details are missing or more substantive aspects of the submission have not been included.

In a very interesting response to a question regarding the issue of “synthetic” copies of herbal and botanical extracts, Dr. Fabricant seemed to indicate that while he believes that FDA has been clear in its position on synthetics, citing the ephedra rule and the FDA’s response to the homotaurine citizen petition as precedents, he suggested that their focus was on “synthetic botanicals,” not necessarily other ingredients, although it is unclear as to why FDA would take that position.

The one thing that is clear is that a strict adherence to this guidance document will result in many, many, many more NDI notification submissions for not only dietary ingredients, but for dietary supplement products that contain those NDIs, a situation that Dr. Fabricant stated he would love to see happen. The greatest debate may rest in the scope and sufficiency of the safety data submitted in support of new dietary ingredients as well as dietary supplements containing those ingredients. Compiling sufficient data to support safety of multi-ingredient / multi-NDI formulas may require clinical and toxicological tests on products (as well as the inevitable financial costs), which could, at a minimum, substantially delay the time it takes for a company to bring a new product to market, if not prevent products of this kind from being marketing entirely.

We will continue to stay abreast of these developments and to work with our clients to assess the affect this guidance document will have on the products they manufacture and/or sell and to help them with their compliance.