The status of bioidentical ingredients has been one of the hot button issues in the industry ever since the release of the first version of the New Dietary Ingredients draft guidance in 2011. That guidance, after much pushback from industry and lawmakers, was withdrawn and reissued last year. But while the Food and Drug Administration addressed some of industry’s concerns in the updated draft, it did not waver question of whether the process applies only to new ingredients, or to all new finished products that contain new ingredients (as far as FDA is concerned, it’s the latter). Nor did it budge on the question of synthetic botanicals, also called nature-identical compounds. FDA’s position at the moment is that these are not legal dietary ingredients for the simple reason that while these ingredients might look like molecules found in a botanical they didn’t come from there.
The United Natural Products Alliance has announced plans to put on a summit on the NDI Draft guidance on Feb. 9 in Salt Lake City. Among the speakers will be Jim Thomas, research program manager of the ETC Group, which is a non-governmental organization (it bills itself as a Civil Society Organization, or CSO) based in Ottawa, Canada that monitors emerging technologies and how they impact indigenous farmers in the poorer regions of the globe. While many in the developed world might look at new technologies and say, “Cool! Let’s do it!” Thomas and his colleagues ask the question: “What unintended consequences might unfold if we do?” Thomas will give a talk as part of the one day event to detail the ways in which synthetic biology, one of the technologies that ETC Group monitors, has been used to produce bioidentical ingredients. Thomas’s goal will be for those in the room who hear his talk to take a step back from the technical debate of whether FDA got the synthetical botanical question right in the draft guidance to reflect more deeply on how these ingredients are made and what having them on the market might mean for producers of the ingredients that actually were resident to begin with in a plant.
Tweaking the code
In the food realm technology up to now has been used to produce flavor and fragrance ingredients, but scientists working on the technology have said that in principle any bioactive molecule could potentially be produced in this way. The core of synthetic biology is to tweak the genetic code of a fermentation microorganism to produce more of a metabolite of interest than it was already capable of making, or to create a new bug that secretes an entirely new molecule. Proponents of the process claim that it uses fermentation, an already familiar tool, and uses food grade inputs.
But Thomas said that in his view it’s hard to fit the process into an industry that marches under the banner of “natural products.” And the technology can, intentionally or otherwise, disenfranchise producers of natural ingredients in indigenous settings.
“That’s the conversation I’m interested in having in Salt Lake City,” Thomas told NutraIngredients-USA. “We’ve been tracking where synthetic biology is going with flavors, fragrances, and oils. We are looking at where this production method is turning up in things that are relevant to the supplement industry. We are beginning to see synthetic biology turn up in the production of many high value compounds.”
Thomas said the technology was at first applied to things like biofuels, but developers found it difficult to scale the process up sufficiently to compete in these vast commodity markets. So they turned to food and later supplement ingredients, where the value of the product is higher and production runs are short.
Natural? Or not?
The key issue, Thomas said, is the way in which producers of these sorts of ingredients want to be able to straddle both sides of the technological fence. On one hand, they use a highly efficient, high-tech process to produce their ingredient while at the same time wanting to be able to call it ‘natural’ by dint of the use of fermentation, which they view as a natural process at its core. It is a highly troubling development for producers of truly natural ingredients, Thomas said.
“I was in Grenada recently, and government officials there are very concerned about how synthetic biology might affect the markets for the products like nutmeg or cinnamon from their indigenous spice industry,” he said.
True transparency? Or lip service?
Some proponents of synthetic biology, companies like Ginkgo Bioworks in Boston, say they want to be transparent about what they are doing and claim to be in favor of GMO labeling. Thomas said in his experience such companies often trot out a few flagship ingredients that might fit into the transparency story, while doing a lot of confidential work for customers on the back end.
“They are producing a lot of ingredients for companies that they are not disclosing. For the most part we feel as if they are bing fairly secretive about what they are doing. We have a very strong concern about the way in which the platform is being used to grab the highest value compounds and produce large quantities that might destroy the value for the natural producers,” he said. Thomas said the technology has been used to produce synthetic vanillin, saffron, resveratrol and some carotenoids. ETC Group is trying to nail down all the places where synthetic biology is being employed, but the picture is rapidly changing and the secretive nature of the players involved makes this a work in progress, Thomas said.
“It’s an interesting question to ask, ‘What is progress?’ For us it is something that supports communities and the livelihoods of the people within them. It’s about looking at the displacement caused by some technologies and asking if it is worth it. In some cases this technology is taking away the value of plant based materials that communities have stewarded and developed over centuries,” Thomas said.
For more information or to register for UNPA's one-day event on Feb. 9, titled NDI III: Roadmap to a Viable NDI Policy, click here.