In response to a Consumer Advisory issued by FDA on DMAA, the Council for Responsible Nutrition (CRN), the leading trade association representing the dietary supplement industry, issued the following statement:
Statement by Steve Mister, president & CEO, CRN:
“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.”