Frank Jaksch, CEO of ChromaDex, spoke with NutraIngredients-USA at the recent SuppySide West trade show in Las Vegas, NV. From Jaksch’s point of view, the process laid out by the Food and Drug Administration in the updated draft guidance on New Dietary Ingredients is one that responsible companies supplying dietary ingredients ought to be able to successfully comply with. Jaksch has in the past expressed little patience for the prevalence of loose standards and substandard ingredients that characterizes a fringe of companies operating in the industry.
“The new guidance seems to make it pretty clear that FDA is saying we are going to help the guys who want to do things right. I think it is going to be a big tool to help clean up the marketplace,” Jaksch said.
Jaksch sees as especially helpful the detail contained in the guidance on the actual filing process and what FDA is looking for in terms of documentation from companies. He said it will help companies, including his own, craft a coherent message—a ‘story’ if you will—about the safety profile of an ingredient and why it matches the definition of a dietary ingredient.
“We went though painstaking detail to get our NDI on Niagen (the company’s branded form of nicotinamide riboside) and to get GRAS status,” Jaksch said. “What we see in the new guidance is you can follow your own playbook in terms of what science you are going to put into the package.”
GRAS vs NDI for synthetics
As far as the definition of a dietary ingredient goes, ChromaDex has some exposure there in the form of another product in its portfolio—pTeroPure. This is a synthetic form of pterostilbene, a molecule related to resveratrol that can be found in blueberries, Japanese knotweed and other botanicals albeit in low, difficult-to-extract quantities. While ChromaDex’s marketing on the ingredient for years said ‘found in blueberries’ the company never actually claimed it derived it from there and forthrightly stated the ingredient was synthesized and even played up that fact by spinning a story of higher purity and more consistent quality and supply.
Both in the 2011 version of the NDI draft guidance and in the most recent iteration, FDA has flatly asserted that so-called ‘synthetic botanicals’ or nature identical compounds do not meet the definition of a dietary ingredient as laid out in DSHEA. The agency’s reading of the statute leads it to conclude that to fall under that definition, botanical ingredients must actually arise from plants, and synthesized compounds, however similar they might be to the botanically-derived versions they are intended to mimic, don’t qualify. The synthetic vitamin horse left the barn decades ago, but some within the dietary supplement industry have observed that it makes little sense to look the other way on synthetic vitamin C yet zero in on newer synthetic ingredients.
PTeroPure has self-affirmed GRAS status, a loophole in the 2011 version of the NDI draft guidance that has been de-emphasized in the most recent version. New ingredients that have complied with this process (which includes of course submitting the GRAS filing directly to FDA) do not have to file an NDI notification. While FDA seems to be less than comfortable with the notion that companies can convene their own panels to assess the safety of new ingredients in the food supply, the self-affirmation provision is written into law, so it’s not a path FDA could entirely shut down without trying to go through a formal rule making procedure.
Can a synthetic succeed?
Despite the obvious pitfalls, Jaksch said he believes an NDI filing on pTeroPure could succeed if the right story were told.
“We are going to dial our strategy into working around what the regulation is. I would always recommend a company ask for a pre-meeting with FDA to see if there any big holes in submission to you need to plug beforehand,” he said.
“Synthetic ingredients have their own challenges. We intend to go in there with a logical story about why we believe this makes sense. We have never found the agency to be unreasonable. There is always the opportunity to negotiate a position by telling the right story. A way needs to be found to incentivize the companies that are wiling to do things right in terms of safety, toxicology, and regulatory questions,” Jaksch said.