According to the draft guidance, published in July, the use of modern technologies (such as super critical C02 extraction) or solvents other than water or aqueous ethanol to make extracts will “likely” be considered to cause a ‘chemical alteration’, thereby triggering an NDI notification.
This has provoked a storm of controversy in the trade, which argues that the relevant issue when assessing dietary ingredients should be safety, “not the relative novelty of how the ingredient is prepared per se”.
While the ABC white paper – which will be available electronically or as a printed reference book in February/March 2012 - was never intended to provide legal proof of which solvents were first used for which dietary ingredients and when, it would help inform discussions about a more useful definition of ‘chemically altered’ within the NDI debate, said ABC executive director Mark Blumenthal.
Meanwhile, the use of several solvents other than water and ethanol to produce botanical extracts most likely preceded the passage of the 1994 Dietary Supplement Health and Education Act (DSHEA), proof of which should be “an adequate basis on which to obviate the requirement to submit an NDI notification”, added Blumenthal, who was speaking to NutraIngredients-USA as part of our end-of-year review.
”However, the challenge is that while solvent X might have been used for decaffeinating coffee in the 1970s or 80s, establishing whether it was used for producing a ginger extract before 1994 might be more problematic.”
Regulation and bad press not the biggest issue facing the trade
But while the NDI guidance was a huge concern, it was not in fact the biggest thorn in the side of the supplements sector, suggested Blumenthal.
“The biggest threat to this sector is not regulation, or the negative media reports [the recent vitamins will lead you to an early grave headlines], but quality control and maintaining the integrity of the supply chain.”
While unscrupulous players looking to make a fast buck out of economic adulteration would always be a threat, the ABC’s new series of white papers highlighting frequently-used adulterants for key botanicals and offering expert commentary on appropriate testing methodologies was helping firms fight back, he said.
Grandfathered list suggestion not universally popular
As for the thorny issue of how to prove the ‘grandfathered’ status of dietary ingredients allegedly used in supplements pre-DSHEA, Blumenthal’s suggestion that the FDA should recognize the existing industry lists but work with an expert panel to clarify their contents has not been universally welcomed by stakeholders, he acknowledged.
“Some people don’t like the idea of positive lists, because they don’t like the ides of things being codified. But what we are proposing is that this would be a dynamic list that is subject to revision.”