By Elaine Watson Nutra Ingredients USA
It’s official, says the FDA. “Synthetically-produced DMAA (1,3-Dimethylamylamine) is not a dietary ingredient and is not, therefore, eligible to be used as an active ingredient in dietary supplements”.
After months of heated debate about the source, safety and regulatory status of the popular stimulant, the FDA has issued warning letters to 10 manufacturers and distributors of supplements containing DMAA “for marketing products for which evidence of the safety of the product has not been submitted to the FDA”.
Failure to immediately cease distribution of the supplements in question could result in enforcement action “without further notice”, added the agency, wich claimed DMAA increased blood pressure, which could in turn "increase the work of the heart such that it could precipitate a cardiovascular event".
It added: "It has come to our attention that DMAA used in products in the dietary supplement marketplace may be produced synthetically... Synthetically produced dimethylamyline is not a dietary ingredient as defined in section 201 9ff) (1) of the [Food Drug and Cosmetic] Act."
What legal avenues are open to targeted firms?
Asked how it would respond if the firms targeted claim they can prove the DMAA in their products is a synthetically produced copy of a botanical constituent (from geranium) that has been safely consumed in the food supply for years, an FDA spokeswoman told NutraIngredients-USA:
"We need to refocus to point out that 1) these are open cases; the firms have 15 days to respond and we are awaiting their responses; 2) the violation cited in the warning letter was a failure to file new dietary ingredient (NDI) notifications per the statutory requirement, which renders the products adulterated as such and at present, that's the matter at hand, anything else at this time is speculative."
Asked if the FDA planned to follow its new draft guidance on NDIs - which says it does not recognise synthetic copies of botanical constituents as dietary ingredients - the same answer applied, she said.
NSF International: The FDA is following the correct path
The FDA's crackdown was immediately blasted by supplement retailing giant G.N.C - click here - but welcomed by analytical testing experts, many of whom have long argued that the DMAA is not found in geranium.
Ed Wyszumiala, general manager of dietary supplements programs at NSF International told NutraIngredients-USA: “We agree and have long stated that DMAA is a synthetic product, an off patent pharmaceutical active ingredient, and not eligible to be used in dietary supplement formulations.
“The agency is following the correct path. The key to this issue has always been safety, and the agency has tools such as NDI notifications and severe adverse event reporting to help fully enforce DSHEA and provide adequate market surveillance. In this case, there was no NDI filed and the safety concerns were caught through adverse events reported to the agency.”
Frank Jaksch, chief science officer at ChromaDex, told NutraIngredients-USA: “This is certainly not a surprise. It was really not a matter of if this notice would come…it was really more of a matter of when.”
Flora Research: This is the end of a long run for DMAA
James Neal-Kababick, director of Oregon-based Flora Research Laboratories, said the crackdown was the “end of a long run for DMAA” and came as no surprise given that credible research “has failed to indicate any detectable DMAA in geranium oil even using the power of a research grade High Resolution Gas Chromatography-Mass Spectroscopy instrument”.
“DMAA is methylhexaneamine, a drug developed by Lily in 1944 and was patented again in 1971 as Forthane, a nasal decongestant. In the late 1970’s, this drug was withdrawn from the market.”
He added: “But we must now turn our attention to the next replacements. There are already alternative drugs being sold as botanical extracts on the market today.”
American Botanical Council executive director Mark Blumenthal added: “The overwhelming chemical evidence does not support the contention by some commercial entities that DMAA is a naturally-occurring component of geranium oil.
"The FDA's action is not a big surprise.“
CRN: This is not a black and white issue
However, Council for Responsible Nutrition (CRN) chief executive Steve Mister said he did not interpret the FDA’s warning letters as a blanket rejection of DMAA.
Indeed, the letters were the start, and not the end, of the debate, he said.
The CRN has no vested interest in DMAA, he said, but added: "We've always said we don't want to rush to judgment on this and I'm not here to defend DMAA, but there are wider issues at stake here. The science of this has to play out, and hopefully this is now an opportunity for the companies listed to give us some more clarity on its safety."
Meanwhile, the debate over whether synthetic copies of botanical constituents are dietary ingredients was not over, he said.
“I don’t see this as a black and white issue. There are many shades of grey.”
Fabricant: DMAA is known to narrow the blood vessels and arteries
In a press release, FDA supplements division boss Dr Daniel Fabricant said no NDI notification had been submitted for DMAA-containing supplements: “Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated.”
The FDA has received 42 adverse event reports (AERs) on products containing DMAA, it said: “While the complaints do not establish DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death."
It added: "There is no information demonstrating that DMAA was lawfully marketed as a dietary ingredients in the US before October 15th 1994, nor is there any information demonstrating that it has been present in the food supply as an article used in food in a form in which the food has not been chemically altered."
The recipients of the warning letters (listed below) have 15 business days to respond.
Exclusive Supplements (Biorhythm SSIN Juice)
Fahrenheit Nutrition (Lean Efx)
Gaspari Nutrition (Spirodex)
iSatori Global Technologies, LLC (PWR)
Muscle Warfare, Inc. (Napalm)
MuscleMeds Performance Technologies (Code Red)
Nutrex Research (Hemo Rage Black Lipo-6 Black Ultra Concentrate Lipo-6 Black Lipo-6 Black Hers Ultra Concentrate Lipo-6 Black Hers)
SEI Pharmaceuticals (MethylHex 4,2)
SNI LLC (Nitric Blast)
USP Labs, LLC (Oxy Elite Pro Jack3D)
Is DMAA safe?
USP Labs did not respond to a request for comment but cites several safety studies on its website (click here) including one eight-week study feeding OxyELITE Pro to 32 exercise-trained men and women published in Nutrition and Metabolic Insights last month and a new 10-week study on Jack3D with 25 exercise-trained men – with results pending publication.
While OxyElite Pro increased heart rate by an average of six beats per minute in the first study, this was “comparable to the effect seen in some studies after the administration of caffeine dosages equivalent to two or three cups of coffee”, claimed the firm.
When asked on what basis it believed DMAA was unsafe, the FDA spokeswoman added: "The AERs, plus the known activity of the of the ingredient in question are concerning."
But the FDA action, she stressed, was based on the fact that no NDI had been submitted for supplements containing DMAA.
Click here to see G.N.C.'s reaction to the FDA crackdown.
Click here to see the NutraIngredients-USA timeline.