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June 12, 2018
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.
Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition
Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.
Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.
Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.
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