In a long-running dispute over the legality of DMAA, a federal appeals court has virtually extinguished a supplement manufacturer's court challenges unless it requests, and is granted, review by the U.S. Supreme Court.

Josh Long, Associate editorial director, Natural Products Insider

April 20, 2020

3 Min Read
Court saga over DMAA-containing supplements may be over

A federal appeals court has dealt what may be the final blow to Hi-Tech Pharmaceuticals Inc. and its owner in their long-running battle with the government over the legality of DMAA (1,3-dimethylamylamine) in dietary supplements.

FDA has described DMAA as an “amphetamine derivative” marketed in sports performance and weight loss products and often sold as dietary supplements.

In an April 8 decision, the U.S. Court of Appeals in Atlanta denied Hi-Tech’s request for a rehearing before the entire panel, virtually extinguishing Hi-Tech’s court challenges unless it requests, and is granted, review by the U.S. Supreme Court.

Hi-Tech, a supplement maker in Norcross, Georgia, FDA and the U.S. Department of Justice either declined comment on the development or did not immediately respond to requests.

Last year, in a 2-to-1 decision, a three-judge panel of the 11th Circuit affirmed a 2017 district court summary judgment order, which held DMAA is not a dietary ingredient under the Dietary Supplement Health and Education Act of 1994 (DSHEA).

“DMAA is not an ‘herb or other botanical,’” District Judge Robert Hinkle wrote in the 11th 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.”

The 11th Circuit issued its decision declining to rehear the case about a month after Hi-Tech was sued in California in a putative class action suit over alleged deceptive advertising and business practices. The federal lawsuit alleged Hi-Tech, doing business as APS Nutrition, duped consumers through the sale of dangerous ingredients flagged by FDA, including DMAA and two other ingredients known as DMHA (1,5-dimethylhexylamine) and methylsynephrine.

Jack Wenik, an attorney representing Hi-Tech, said the company denied the allegations and planned to "vigorously defend itself." 

DMHA, however, also is the subject of civil litigation between Hi-Tech and the government. Hi-Tech in 2019 filed a lawsuit against FDA in the U.S. District Court for the District of Columbia, alleging the agency was responsible for an “arbitrary and capricious” enforcement action against DMHA, a stimulant also known as octodrine.

In July, Justice Department lawyers filed a motion to dismiss the suit, arguing the complaint was premature since FDA had only issued warning letters over DMHA that fail to “constitute final agency action” per the Administrative Procedure Act (APA). Hi-Tech countered the case was ripe for adjudication and that the “impacts of the FDA’s actions are not theoretical” because they threatened the “freedom” of Jared Wheat, Hi-Tech’s owner.

In a separate criminal case against Wheat, as part of his bond conditions, he must not produce, distribute or sell any “adulterated foods or misbranded drugs,” according to a 2019 memorandum filed by Wenik of Epstein, Becker & Green P.C.

“The FDA’s DMHA warning letter is unambiguous in that it considers the continued marketing of DMHA-containing dietary supplements ‘violations’ of various provisions of DSHEA and that the products containing DMHA are adulterated,” Wenik wrote in the memo, which opposed the government’s motion to dismiss. “Thus, Mr. Wheat faces the very real threat that the United States Attorney’s Office … could move to revoke his bond based on nothing more than the FDA’s assertion that Hi-Tech’s DMHA-containing products are deemed adulterated by statute.”

As of today, U.S. District Judge Reggie B. Walton hadn’t ruled on the government’s motion to dismiss the suit.

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.

Subscribe and receive the latest insights on the health and nutrition industry.
Join 37,000+ members. Yes, it's completely free.

You May Also Like