European food and medicines agencies will follow the lead of the US Food and Drug Administration (FDA) which last week issued warning letters to 10 manufacturers over safety and authenticity concerns for DMAA products, an EU food law expert has said.
"From a European standpoint, the US FDA's position on DMAA is extremely important, and probably decisive,” said Luca Bucchini, PhD from the Italian firm, Hylobates Consulting.
“It seems hard for EU sellers of DMAA supplements to prove to national authorities that the FDA is wrong, or for EU authorities to disagree with the Americans, unless the US agency changes its mind.”
Pressure has been building in various countries to ban DMAA (methylhexaneamine/1,3-dimethylamylamine) as adverse events have been reported and questions over the stimulant’s synthetic or botanical (geranium) source have remained unanswered.
“…cardiac disorders, nervous system disorders, psychiatric disorders, and death.”
The FDA referenced both issues in its missives that have given companies 15 days to respond, while US-based supplements retailing giant, GNC, labelled the FDA action, “factually and legally unfunded”.
"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," said Daniel Fabricant, PhD, director of the FDA’s Dietary Supplement Program.
The FDA said it had received 42 adverse event reports (AERs) including, “cardiac disorders, nervous system disorders, psychiatric disorders, and death.”
“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,” it added.
End of the road?
For Bucchini, the long-awaited FDA stance, which joins agencies in Canada, New Zealand and the UK in condemning the ingredient first made by pharma firm Eli Lily in the 1940s, is definitive and far-reaching.
“Is this the end of the road for DMAA in Europe?” he wondered. “It's very probable. It would be odd that European authorities take a less precautionary approach than the FDA."
Any ban would apply to anyone selling supplements in the EU, “internet retailers included.”
“The FDA has also confirmed that there's no evidence of history of safe use,” Bucchini added. “One key EU member state was hesitant to classify DMAA as novel food, and the FDA's finding may be decisive in changing their mind.”
Recipients of the FDA warning letters are:
- 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)