Supreme Court settles fate of DMAA

The U.S. Supreme Court has denied a petition for a writ of certiorari filed by a supplement manufacturer and its owner.

Josh Long, Associate editorial director, Natural Products Insider

October 20, 2020

2 Min Read
Supreme Court settles fate of DMAA

The nation’s highest court has rejected a request to review a case involving the legality of DMAA (1,3-dimethylamylamine), a once-prevalent ingredient marketed in sports supplements.

On Monday, the U.S. Supreme Court denied a petition for a writ of certiorari filed by Hi-Tech Pharmaceuticals Inc. and its owner, Jared Wheat.

The decision brings to a close seven years of litigation, leaving in place a 2019 ruling by an appeals court, which held DMAA does not belong in supplements. FDA describes DMAA as an “amphetamine derivative” that can pose health risks to consumers, especially when used in combination with other stimulants like caffeine.

Wheat did not immediately respond to a request for comment, and FDA declined to comment.

Dan Fabricant leads the Natural Products Association (NPA) and previously directed what was then known as FDA’s Division of Dietary Supplement Programs. He welcomed as “good news” the Supreme Court’s refusal to hear the case.

During his tenure at FDA, Fabricant said, no manufacturer demonstrated to FDA the safety of DMAA through a new dietary ingredient notification (NDIN)—a requirement of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Fabricant led FDA’s supplements division when it issued warning letters in 2012 to supplement brands selling DMAA.

FDA concluded at the time that DMAA-containing products were adulterated because the required safety-related notification had not been submitted to the agency.

Although Hi-Tech did not receive a warning letter in 2012, FDA seized DMAA-containing products from the supplement manufacturer in 2013. That triggered a seven-year-old legal battle between the Georgia-based company and federal government.

While Wheat acknowledged DMAA used in his supplements was synthetically produced, Hi-Tech presented evidence to show the ingredient comes from geranium plants. But ultimately, a federal district court ruled—and the U.S. Court of Appeals for the Eleventh Circuit concurred—that DMAA does not meet the definition of a dietary ingredient in DSHEA.

“[I]t is unlikely that Congress used the term ‘constituent’ to mean a substance that is present in a plant in only trace amounts and that has never been derived from a plant for use in any medicinal, cosmetic or dietary product,” U.S. District Judge Robert Hinkle, who wrote the Eleventh Circuit’s majority opinion, concluded.

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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