FDA issued 11 warning letters in 2012 to manufacturers and distributors of supplements containing DMAA, stating that DMAA was not a lawful dietary ingredient because it lacked a New Dietary Ingredient notification, and raised the issue of whether it is a so-called synthetic botanical.
USPlabs, manufacturer of Jack3d and OxyElite Pro, both of which contain DMAA, responded to FDA on that issue, defending its use of the ingredient.
In a Consumer Update from FDA, the agency notes: “All but one of the companies sent a Warning Letter have agreed to stop using DMAA as an ingredient in their dietary supplements. The one company that has yet to agree to such action, USPLabs, has responded to FDA's warning by submitting published studies that purport to challenge FDA's conclusions.
“However, after reviewing the studies provided by USPLabs, FDA has found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements.”
In a telephone interview with NutraIngredients-USA, Daniel Fabricant, PhD, director of FDA's Division of Dietary Supplement Programs, confirmed that FDA will finalize a formal response to the firm “rather shortly” to reflect its findings.
The Consumer Update also notes that the agency has received “86 reports of illnesses and death associated with supplements containing DMAA”.
“We want to be clear about where we are. We don’t want people using DMAA,” added Dr Fabricant.
Dietary supplement regulations and DMAA in particular are at the center of a report to be broadcast on NBC’s Rock Center this evening. For NBC’s preview article and short video, please click here.
DMAA (also known as methyl hexaneamine (MHA) and several other names) has been a subject of intense debate about whether it is in fact a constituent of geranium. The ingredient was first manufactured synthetically by drug giant Eli Lily in the 1940s.
The ingredient has come under scrutiny across the globe and is currently banned in six countries, as well as by the US military.
Only three analyses have reported it to be a natural constituent of geranium: The controversial ‘Ping Paper’ by Chinese researchers published in the Journal of Guizhou Institute of Technology (1996, Vol. 25, pp. 82-85), and two recently published papers in Analytical Chemistry Insights funded by USPLabs.
On the flip side, there are more studies that have failed to find DMAA in geranium plant material, including an analysis published in the Journal of Analytical Toxicology in June 2012 described as ‘comprehensive’ and ‘robust’ by respected members of the industry.
CRN: We appreciate that FDA has made its decision
Steve Mister, president & CEO of the Council for Responsible Nutrition (CRN), welcomed the Agency making a decision on the ingredient.
“For over a year, DMAA has been an ingredient under question. CRN has looked to FDA to determine whether this ingredient is safe or not safe, as well as whether this product could be considered a legal dietary ingredient for use in supplements. As the primary agency charged with regulating dietary supplements, FDA is in the best position to evaluate the safety of the ingredient and determine whether it should be available to consumers," said Mister.
"No CRN member companies manufacture the ingredient or products containing DMAA, and much of the research on DMAA is not publicly available, so we have relied on FDA to evaluate the evidence. CRN appreciates that FDA has made its decision with this announcement.
"It is clear from FDA’s Consumer Advisory that, having evaluated the evidence, FDA views DMAA as unsafe and warns that it presents unreasonable health risks to consumers. FDA also stated that, in its view, products containing DMAA are illegal and should not be sold as dietary supplements. With this conclusion, CRN now calls on dietary supplement manufacturers to stop manufacturing these products and further advises consumers to stop using them.
"The safety and well-being of consumers is always our highest priority. Given the agency’s serious warnings about DMAA, we expect the agency will use the full range of its regulatory authority under the Dietary Supplement Health and Education Act (DSHEA) and take further action beyond the Consumer Advisory. DSHEA provides the agency with a variety of tools, many of which FDA mentions in its Advisory (e.g., detentions, seizures, voluntary and mandatory recalls, injunctions, criminal prosecution, etc.), to protect consumers.
"Exercising that authority will demonstrate that the current law provides a robust framework to protect consumers when the agency believes a product regulated under its jurisdiction is unsafe. We recognize that a thoughtful and thorough scientific evaluation of the data takes time, as it should, but now that a determination has been made, we encourage FDA to do what is necessary to resolve this issue.”
To access NutraIngredients' extensive coverage of this issue, please click here.