The document, which has provoked a storm of controversy in the trade, explains that dietary ingredients produced with the use of new solvents, manufacturing processes or extraction methods require an NDI notification if the process alters the chemical composition or structure of the ingredient.
While changing a solvent and/or an extraction process could alter the chemical composition or structure of the ingredient and “theoretically be the basis for potential safety problems”, this was not automatically the case, said Mark Blumenthal, executive director at the American Botanical Council.
"The issue is human safety, not the relative novelty of how the ingredient is prepared per se....Previous comments from FDA did say that any novel solvent or extraction process could trigger NDI status but not necessarily that it would trigger it.
“ABC's concern lies in the area that a new solvent and/or new extraction process per se should not trigger an NDI, and the focus should still be on the eventual safety of the ingredient, not on its solvent or process of extraction as primary criteria.”
Synthetic botanical constituents
Meanwhile, the arguement that synthetic botanical constituents, even if they are chemically identical to their ‘natural’ counterparts - are not dietary ingredients at all, was "problematic", he claimed.
He said: “While a synthetic version of a botanically-derived constituent may be deemed by FDA as not a dietary ingredient, then how does one explain synthetic vitamin C which, in its natural state can be extracted from citrus and/or capsicum peppers and/or cammu cammu fruits and other relatively high vitamin C-containing foods, but is commercially made from non-vitamin C containing foods (eg, corn?).
“Is the FDA now saying that synthetic vitamin C is no longer an allowed dietary ingredient?”
He added: “ABC is willing to concede, in principle, that synthetic ingredients might be considered NDIs ipso facto. However, we add one reservation: Chemical synthesis makes a ‘synthetic’ material, per se. However, a process like fermentation creates an ingredient via biosynthesis, and this is the source of numerous dietary ingredients.
“While ABC prefers to focus on natural plant materials, plant extracts, and plant-derived compounds, we are aware that some plant-based dietary ingredients are now produced - for the sake of cost and efficiency - via fermentation.
“L-theanine may be an example, where the resulting ingredient made via fermentation is claimed to be chemically identical and, presumably, biologically similar or identical in action to the L-theanine found in green tea leaves.”
Industry has been moving towards single compounds
One industry source told NutraIngredients-USA.com that many ingredients now used in supplements were now single - often synthesized - compounds rather than the complex plant extracts that most pre-1994 data focuses on, in part because firms wishing to make claims have focused on single compound study designs to support these claims.
He added: "The FDA wants to drive us into single compounds and then complains that we are not using plants anymore. We can’t track green tea through the bloodstream and tie it to clinical antioxidant outcomes, but we can trace EGCG. So now people are putting in synthetic EGCG."
FDA dietary supplements division boss Daniel Fabricant said it was indeed likely that several products currently on the market contained synthesized versions of botanical extracts that were not dietary ingredients, although he did not name names or cite what enforcement activity was planned to address this anomaly.
Click here to read our interview with Dan Fabricant of the FDA.