“There is still a lot of innovation in my opinion, especially compared to some industries like pharmaceuticals. We see ingredients coming from rain forests, coming from traditional medicine, coming from other parts of the science community.The whole development process in this industry tends to be quick,” Israelsen said in speaking with NutraIngredients-USA at the recent SupplySide West trade show in Las Vegas, NV.
Israelsen, whose organization’s full name is the United Natural Products Alliance, said that the dietary supplement industry’s relatively robust record of safety has in the past allayed concerns about toxicity connected to new products. The number of dietary ingredients and the products that contain them that conclusively have been shown to have harmed consumers is vanishing small, especially when clearly adulterated products such as spiked sports nutrition supplements are eliminated from the data set.
But the New Dietary Ingredients draft guidance would change all that, Israelsen said. The guidance as written proceeds from a underlying point of view that the existing safety record of the industry is no guarantee of future performance. It assumes that most manufacturing changes to existing Old Dietary Ingredients, such as new extraction or filtration technologies or new methods of boosting bioavailability of hard-to-absorb compounds, will raise new toxicity concerns that must be addressed in the form of additional New Dietary Ingredient notifications. And, in a new twist that critics say goes far beyond the underlying statute, those safety concerns extend to every new finished product that contains an NDI, meaning most new product launches will have to have a regulatory filing attached to them.
“Let’s say the industry as a whole said tomorrow we will comply with the guidance as it stands. We will look back through our list of every old ingredient and see if at some step of the way it became new somehow. If you do all that work, it would change the pace of innovation dramatically. Perhaps in the view of FDA, that pause would be a good thing. In the view of industry that pause could be more like a freeze,” Israelsen said.
Israelsen said the guidance could also alter the pace of investment into the industry. Investors seeking to acquire ingredient suppliers or finished goods manufacturers can now be expected to start drilling down into lists of ingredients to see if there is regulatory work that must be done to bring those into full compliance in this new landscape. All that work costs money, and that could get knocked off the purchase price. Or the implied risk could scare investors away altogether while they wait to see how the dust settles.