How NDI Draft Guidance is a Game Changer

Having spent over 30 years in botanical and botanical extracts activity, NDIs, to me, always seemed like the most elusive piece of DSHEA. For quite some time industry seemed comfortable with the efforts various trade associations spent compiling a comprehensive list of herbs in commerce pre-DHSEA. However, it started to become evident four to five years ago that those efforts were not likely to be sufficient to comply with the emerging discussion and direction on how the law would be interpreted.

Having worked with companies who sourced nearly all of their botanicals outside of the U.S., it was a daunting task to think about how a rigid interpretation of an ODI/NDI would affect the overall supply chain.  As some finished product customers began waking up to the new reality and started asking questions and proof of ODI status for ingredients, most supply companies were clueless—especially those that were simply buying/selling/trading/flipping materials, etc.: a big part of our industry. 

Things really started to crank up when a GAO report came out about 18 months ago citing specific products of interest and accompanying letters of inquiry that were sent to larger supplement manufacturers asking for proof of ODI status. The ingredients asked for would be considered old and traditional compared to the newer, designer ingredients of the past decade. I remember thinking if suppliers are struggling with these “relic” ingredients, which some were, the more modern botanicals extracts of the day don’t have a prayer.

Those that have spent any reasonable time in industry have known this day was coming.  We may not have known what the parameters would ultimately be, but there were enough signs given and chatter building that the well-intentioned efforts of the late 1990s to corral the herbs then in commerce was not going to save our souls. Securing an NDI approval is no small task, and it likely has only gotten larger this past week. It is not inexpensive either. There was also no protection or marketing advantage one could expect for such an investment when others could freely sell a similar offering without a similar investment in legal compliance. 

I suppose the day of reckoning is finally here. Those that made the commitment to obtain NDIs with resources and foresight should be in a better position to reap deserving rewards for past efforts.  

Significant changes are coming. Manufacturers of supplements will need to take a hard look at their buying habits and seek out those ingredient suppliers who are compliant in their offerings. Frankly I don’t see ingredient suppliers doing this alone. Most don’t have the requisite skill sets, resources, or managerial commitment. It may require a group effort (the supplier and a handful of their larger customers for a given ingredient) to feasibly make this work. New alliances may be struck. New business opportunities may emerge.

Time will tell, but the rules of the game are definitely changing.