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.
"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."
NSF International: The FDA is following the correct path
Its action was immediately blasted by supplement retailing giant GNC - click here - but welcomed by analytical testing experts, many of whom have long argued that the DMAA in leading pre-workout supplements is not derived from 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. It is good to see the agency taking steps to enforce DSHEA and protect public health.
“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 marketsurveillance. In this case, there was no NDI (new dietary ingredient notification) 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: “We believe 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; many industry experts have thought it was inevitable, sooner or later.“
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. 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."
It also reignited the debate about the FDA's view - as stated in its July 2011 draft guidance on NDIs - that synthetic copies of botanical constituents were not dietary ingredients, he said.
He added: “I don’t see this as a black and white issue. There are many shades of gray.”
Fabricant: DMAA is known to narrow the blood vessels and arteries
In a press release announcing the crackdown, FDA supplements division boss Dr Daniel Fabricant said: “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 release also notes that DMAA is “known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack”.
The FDA has received 42 adverse event reports on products containing DMAA, it said: “While the complaints do not establish that 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 have 15 business days to respond.
Warning letters have been sent to the following firms:
· 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)
