FDA Official on DMAA: ‘We’re Not Sending Warning Letters’

An FDA official last month said her agency hasn’t changed its position on the sale of 1,3-dimethylamylamine (DMAA) in dietary supplements.

“Sometimes, we get questions of, has FDA changed their position because we haven’t seen anything lately on DMAA?” observed Cara Welch, senior advisor to FDA’s Office of Dietary Supplement Programs, during a regulatory conference May 16 in Washington. “We haven’t changed our position. DMAA is an unsafe food additive. It should not be showing up in supplements.”

DMAA was pervasive in sports supplements until 2012—the year FDA sent warning letters to several companies regarding the sale of DMAA in products. One of the companies receiving a letter was USPlabs LLC, the subject of a criminal indictment announced in 2015 by the Department of Justice.

Welch suggested FDA is taking aggressive action when it finds DMAA in a supplement.

“We’re not sending warning letters on DMAA products,” she said during the Dietary Supplements Regulatory Summit, an annual collaboration of five trade associations, including the American Herbal Products Association (AHPA), which spearheaded the 2018 event. “When an investigator goes into a facility and finds it (DMAA), they talk to the owner immediately and say, ‘You need to get this product off the market, and if you don’t do it, we’ll do it.’”

“Fortunately, they often will do that, and they will voluntarily recall and destroy their product,” Welch added.

That relieves FDA from going to court, asking a judge for a warrant to seize the products. “It saves our resources as voluntary compliance, and that’s what we want to see,” she said.

A judge ruled in 2017 that DMAA doesn’t belong in supplements, dealing a victory to FDA in its years-long fight with Hi-Tech Pharmaceuticals Inc. and its president, Jared Wheat. But Hi-Tech and Wheat challenged the summary judgment ruling in an appeal.

The parties are scheduled to make oral arguments in August before the U.S. Court of Appeals for the Eleventh Circuit.