That’s how a petition to the U.S. Supreme Court describes an interpretation of law that limits the types of constituents of an herb or botanical that would meet the definition of a dietary ingredient in the Dietary Supplement Health and Education Act of 1994 (DSHEA).
In 2019, in a 2 to 1 vote, a three-judge panel of the U.S. Court of Appeals for the Eleventh Circuit upheld a district court decision that DMAA (1,3-dimethylamylamine) does not belong in supplements and is not GRAS (generally recognized as safe). But in reaching its decision, the Eleventh Circuit wrote “new words into DSHEA.”
That, at least, is the opinion of Hi-Tech Pharmaceuticals Inc. and its owner Jared Wheat, whose lawyers filed a petition for a writ of certiorari with the U.S. Supreme Court in a 7-year-old battle with FDA over the legality of an ingredient once widely sold in supplements and marketed to bodybuilders and other athletes. According to Hi-Tech, DMAA is naturally found in geranium plants and therefore meets the definition of a dietary ingredient in DSHEA.
The text of DSHEA “says that a presumptively marketable dietary supplement can contain a ‘constituent’ of an herb or other botanical,’” attorneys with Maynard Cooper & Gale P.C. wrote in the Sept. 1 petition to the Supreme Court. “No more, no less. Yet the majority opinion judicially mandated an exception to that text, eliminating the marketability presumption when the constituent is, in the majority’s words, ‘present in a plant in only trace amounts’ and has previously ‘never been derived from a plant for use in any medicinal, cosmetic or dietary product.’
“That wordsmithing was the Eleventh Circuit’s, not Congress’, and the majority opinion did not anchor this verbiage in any part of DSHEA’s text,” proclaimed lawyers for Hi-Tech, a manufacturer of sports nutrition products headquartered in Norcross, Georgia.
In seeking review, Hi-Tech cited a Supreme Court case decided in 2020, Bostock v. Clayton County, Georgia. Factually, Bostock had nothing to do with dietary supplements—it concerned cases in which an employer fired an employee for being homosexual or transgender. But in Bostock, the Supreme Court “emphasized core principles of statutory interpretation that govern all federal statutes,” according to Hi-Tech’s petition.
“When the express terms of a statute give us one answer and extratextual considerations suggest another, it’s no contest,” the Supreme Court wrote in an excerpt of the Bostock decision, quoted in Hi-Tech’s petition. “Only the written word is the law, and all persons are entitled to its benefit.”
The majority opinion of the Eleventh Circuit “invoked what” the Supreme Court “in Bostock called the ‘canon of donut holes,’ carving an exception into the statute that kept DSHEA’s broad text from applying in the specific circumstances of this case,” Hi-Tech’s brief asserted. “The result not only runs contrary to the principles set forth in Bostock, but also will stifle innovation in the dietary supplement industry in ways that run contrary to DSHEA’s most fundamental purposes.”
The Eleventh Circuit’s decision, the brief added, will bar in dietary supplements the use of new compounds found in trace amounts in plants and that have not previously been obtained from plants, regardless of their potential benefits.
“The ordinary understanding of the phrase ‘constituent’ of an ‘herb or other botanical,’ as found in DSHEA, encompasses all substances that, like DMAA, naturally occur in geranium plants and their oils,” Hi-Tech’s attorneys wrote. “There is no doubt that the geraniums and their oils in which DMAA has been detected are ‘botanicals’ for these purposes.”
It’s unlikely the nation’s highest court would review interpretations of DSHEA and whether the Eleventh Circuit imprudently departed from the plain text of the statute in reaching its conclusion about DMAA. Of the more than 7,000 cases that the Supreme Court is asked to review each year, the Justices only accept 100 to 150 cases, according to the Administrative Office of the U.S. Courts.
Jeffrey Wall, acting U.S. solicitor general, waived the government’s right to file a response to the petition—unless the high court requested a response.
As the Hi-Tech case made its way through the judiciary, some industry lawyers found it curious that the U.S. government never raised a legal theory expressed in its 2012 warning letters to several marketers of DMAA. Assuming there is basis to conclude DMAA is a dietary ingredient, it is a new dietary ingredient (NDI) subject to a premarket notification to establish its safety, FDA stated at the time.
In bringing a forfeiture action in 2013 against Hi-Tech’s DMAA products, the U.S. government argued DMAA is not naturally found in geraniums and consequently does not qualify as a dietary ingredient. While the federal district and appellate courts acknowledged conflicting evidence regarding the presence of DMAA in geranium plants, the U.S. government nonetheless prevailed on a “trace amounts” theory it had not espoused in its forfeiture action.
“[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.