FDA is using all available tools at its disposal to ensure that dietary supplements containing a stimulant called dimethylamylamine (DMAA) are no longer distributed and available for sale to consumers in the marketplace.
The ingredient, DMAA, is most commonly used in supplements promising weight loss, muscle building and performance enhancement; it can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine.
As of April 11, FDA had received 86 reports of illnesses and death associated with supplements containing DMAA. The majority are voluntary reports from consumers and healthcare practitioners. The illnesses reported include heart problems and nervous system or psychiatric disorders. Note, however, that a report is not proof that the product actually caused the problem.
FDA has warned companies known to be using DMAA in dietary supplements that those products containing this ingredient are illegal. Such warnings offer the quickest way at FDA's disposal to halt the further distribution of dietary supplements containing DMAA in the marketplace. In fact, 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. FDA is finalizing a formal response to the firm to reflect its findings, according to Daniel Fabricant, PhD, director of FDA's Division of Dietary Supplement Program.
FDA's authority over dietary supplements is very different from its authority over drugs and other medical products. FDA is required to undertake what are usually lengthy scientific and legal steps in order to force the removal of dietary supplements that may be unsafe or are otherwise illegal if companies don't voluntarily comply.
As FDA continues the process needed to get DMAA off the market, the agency is urging consumers to check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The alternatives are listed at FDA's DMAA web page.
In response to FDA’s consumer advisory Steve Mister, president and CEO, of the Council for Responsible Nutrition (CRN), Washington, D.C., issued this statement:
“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. 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.”
FDA Halting Sale of DMAA
Published April 15, 2013