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.