The whole “adventure” over DMAA (1,3-Dimethylamylamine) is “a perfect example of a gaping loophole in the Dietary Supplement Health and Education Act (DSHEA) which needs to closed”, according to one academic.
Dr Pieter Cohen, assistant professor of medicine at Harvard University, was speaking to NutraIngredients-USA after publishing a research letter about the controversial stimulant in the Archives of Internal Medicine (click here ).
In the letter, he notes that since the publication of the much-maligned Ping et al paper in 1996, “more than a half dozen peer-reviewed reports have been unable to confirm” its conclusions - that DMAA is a naturally-occurring component in geranium.
‘You're producing a medication not a supplement’
But even if firms can prove that DMAA is in geranium, and that the DMAA in their products is a synthetically produced copy of a botanical constituent, it still shouldn't be allowed in supplements, argues Cohen.
“If you can find something in one varietal of a plant in microscopic amounts, then produce it [synthetically] at pharmaceutical levels, you're producing a medication not a supplement.
“In my mind, this DMAA adventure is a perfect example of a gaping loophole in DSHEA which needs to closed. That is, synthetically produced botanical ingredients should be not permitted to be sold as supplements [an argument made by the FDA in its draft guidance on new dietary ingredients]."
He added: “Industry advocates would probably agree with me that [this] would require Congress to close that loophole.
“It’s been an experiment - if synthetic botanicals are permitted, then would they be introduced responsibly? It appears to me that answer is no.”
Draft guidance on NDIs and synthetic botanical constituents
The FDA's view - that synthetic botanical constituents, even if they are chemically identical to their ‘natural’ counterparts, are not dietary ingredients - is one of the most controversial assertions in its 2011 draft guidance on NDIs.
Indeed, while the Council for Responsible Nutrition (CRN) believes a “constructive solution” might be found to several key sticking points in the guidance, it will not budge on the synthetic botanicals issue , CEO Steve Mister told us in February.
He said: “We are not going to give on the synthetics issue.”
Speaking to us after the guidance was first published, Wes Siegner, a director at Washington DC-based legal firm Hyman, Phelps & McNamara, said the FDA's stance on synthetic botanical constituents was "lacking in scientific and legal merit".
The American Herbal Products Association (AHPA) has also come out strongly on this issue, adding: “If DMAA exists in geranium through the plant's own synthesis processes, human-synthesized DMAA is also a lawful dietary ingredient."