Claire Kruger is chief executive of consultancy Spherix Health Sciences and has helped several firms prepare premarket notifications for a number of dietary supplements.
Kruger was speaking to NutraIngredients-USA.com following the publication of the FDA’s controversial draft guidance on new dietary ingredients (NDIs), which stipulates that changes to the manufacturing process, new solvents or new extraction methods could trigger an NDI notification if they alter the chemical composition or structure of the ingredient.
She said: “There are valid concerns about the composition changing. If you’ve got an ethanol extract and then you throw it down a chromatography column, it’s valid to look at it again.”
A lot has changed since 1994
A lot had changed since 1994, she added: “We have far more complex kinds of products now that were not on the market in 1994. What have we done to demonstrate their safety? It’s all very well to say that the population had been consuming this substance for years and years, but what if what is actually on sale now has a very different composition or chemical profile?
“What about the differences in impurity profiles and the context in which the component will be delivered?”
She added: “It [the guidance] does sound scary, and I can fully understand why there might be some hyperventilation going on. But we need to think about this from a consumer confidence perspective. If you are introducing a new ingredient to the market and people are ingesting it, it should go through a rigorous and comprehensive process.
“The proliferation of new dietary ingredients [and the correspondingly low number of NDI notifications submitted to the FDA since 1994] makes us ask the question very reasonably: Is the safety of these ingredients being assured? The fact so few companies have notified the FDA leads me to suggest that there is great ignorance out there … so the clarity this guidance provides is a positive step."
It was also important to stress that the guidancewas “not creating a new process or ‘raising the bar’, it’s just clarifying what the existing process actually is”, she added.
Self-affirmed GRAS? No need for NDI…
Firms looking for assistance should look at the NDI and GRAS notifications already submitted, said Kruger. But they should also bear in mind that toxicology studies were not always required in submissions.
“We can sometimes look at the plant and its chemistry and do a tox evaluation from the literature.”
As for the news that FDA would accept both self-affirmed and FDA-affirmed GRAS status in lieu of an NDI filing, which one lawyer claimed had left him “flabbergasted”, she said:
“The process by which self-affirmed GRAS is completed is not subject to FDA review and I would have liked to have seen the FDA notification route more strongly encouraged [in the draft NDI guidance].
Click here to read our interview with the FDA's Dan Fabricant on the new guidance.