Eight years ago, U.S. regulators cautioned 1,3-dimethylamylamine was an unlawful ingredient in dietary supplement products.
Several companies received warning letters in 2012 over the then-popular ingredient known simply as DMAA, which FDA described as an “amphetamine derivative” posing health risks that may lead to such cardiovascular problems as arrhythmias, heart attack or shortness of breath.
Todd Harrison, a lawyer in Washington, D.C., who advises clients on FDA regulations, agreed the vast majority of companies that receive warning letters from FDA try to address the agency’s concerns.
“I would say 90% of them do,” he said in an interview.