A decision Friday by the U.S. Court of Appeals for the Eleventh Circuit marked a victory for FDA and a loss for a dietary supplement manufacturer—Hi-Tech Pharmaceuticals—over the legality of an ingredient in dietary supplements. But the case may not be over.

Josh Long, Associate editorial director, Natural Products Insider

August 30, 2019

2 Min Read
Scales of Justice 2019

A federal appeals court on Friday affirmed a lower court ruling that DMAA is neither an herb nor GRAS (generally recognized as safe) by experts.

The decision by the U.S. Court of Appeals for the Eleventh Circuit marked a victory for FDA and a loss for a dietary supplement manufacturer—Hi-Tech Pharmaceuticals—over the legality of an ingredient in dietary supplements.

FDA officials have long asserted DMAA poses potential safety concerns and doesn’t belong in dietary supplements. But in litigation pending for years, Hi-Tech has maintained DMAA is a safe and lawful ingredient in such products.

A three-judge panel of the Eleventh Circuit ultimately sided with the government, affirming a summary judgment order in 2017 that held DMAA is not a dietary ingredient.

“DMAA is not an ‘herb or other botanical,’” District Judge Robert Hinkle wrote in the Eleventh Circuit’s decision. “It is not a ‘constituent’ of an herb or other botanical. And it is not generally recognized by qualified experts, as adequately shown through scientific procedures, to be safe under the conditions of its intended use.”

Circuit Judge Gerald Tjoflat joined in Hinkle’s opinion. Hinkle is a District Judge in the Northern District of Florida, but sometimes judges hear cases in other courts in which they don’t ordinarily belong.

Circuit Judge Adalberto Jordan dissented, in part, from the majority’s opinion.

“As I read the statute and the record, the FDA was not entitled to summary judgment,” Jordan wrote. “I would remand for a trial on whether DMAA is a ‘constituent’ of geraniums.”

Jared Wheat, owner of Hi-Tech Pharmaceuticals, said Jordan’s interpretation was correct, and he said the company would seek an en banc rehearing. If granted, a full panel of about a dozen judges would hear the case.

An FDA spokeswoman said the agency does not comment on litigation.

About the Author(s)

Josh Long

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.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

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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