NDI Draft Notification: Same Regulatory Strategy, Different Target

I am not an attorney, nor have I ever worked within a law firm or FDA. In contradistinction, I have heard and read many attorneys opine on science, meritorious and spurious clinical trials, and scientific substantiation, despite their lack of science training or experience. I have successfully co-led NDI submissions (acknowledged without exception the first submission) and had the pleasure of working with the attorney (W. Patrick Noonan, Esq.) that led the first NDI submission exactly sixteen years ago (acknowledged without exception): Stevia extract. From this vantage I opine.

About fifteen years ago I was asked, “Why do so many companies in the industry not play by the rules [regarding unsubstantiated product claims]?” A metaphor popped to mind—one that I use almost ad nauseum: “How many cars speed on the [insert your favorite highway or interstate]? The laws are in place and yet the violation to citation ratio is fantastically greater than 1.” The NDI Highway appears no different.

Like a forecasted category 4 tornado, we knew this was coming. The tenor of response from industry could have been predicted—reminiscent of non-positive clinical trials (sponsored by NIH/NCCAM) on hero Old Dietary Ingredients (ODIs) like St. John’s Wort or vitamin E. Since 1994 I have seen the emergence of hundreds of “new” dietary ingredients. Those not possessing an interest in the ingredient asserted “NDI,” those with an interest asserted “Legal opinion letter: ODI.” Beware of a bouncing red laser dot on your forehead, probiotics!

My read of the NDI guidelines rings “food additive GRAS,” shared by some of my close colleagues. How many out there are thinking “GRAS regulatory strategy?” We have championed and exalted “functional foods” and “functional beverages”—even those that meet the definition of a conventional food/beverage (i.e. comprised of GRAS ingredients only).  The functional food industry has blossomed and continues to grow like a Bacillus spore, shielded from the hot winds encircling NDIs. These conventional food/beverage products—quite often simply enriched foods/beverages dressed up as being “functional” (>99% lack decent human evidence on the finished good that aligns with the claims)—do not have a legal precedent delineating claims yet dietary supplement-like claims do they make. Do we go to that highway?

When I am asked about certain ingredients by dietary supplement and food company execs, I ask, “Would you take a product that contains one or more ingredients that are dramatically different, in concentration and/or chemistry, relative to how they occur in Nature, if you knew there were NO human or animal studies systematically demonstrating the actual ingredient’s safety?” I look forward to driving on my highways, and am watching the speedometer much more frequently…