Editorial credit for image: Mark Van Scyoc / Shutterstock.com

Earlier this month, federal officials explained why an appellate court should uphold a ruling that DMAA (1, 3-Dimethylamylamine) is an unsafe food additive that doesn’t belong in dietary supplements.

A government victory on appeal would represent another setback for Hi-Tech Pharmaceuticals Inc. and its owner, Jared Wheat—both of whom are facing a criminal indictment in an unrelated proceeding.

In 2017, Federal Judge Willis B. Hunt, Jr. entered a summary judgment order against Hi-Tech and Wheat, leading to the pending case before the U.S. Court of Appeals for the Eleventh Circuit.

DMAA, government lawyers said, is a chemical compound invented by Eli Lilly & Co. and patented in 1944. Hi-Tech maintained DMAA can be found in the geranium plant and is safe when used at recommended doses in its supplements.

Though Hi-Tech acknowledged its DMAA is synthetically produced, Hunt found credible the argument that a botanical can be synthesized in a laboratory and still qualify as a dietary ingredient under the 1994 Dietary Supplement Health and Education Act (DSHEA).

Nonetheless, the judge concluded DMAA did not meet the definition of a botanical because Congress intended in DSHEA “that there must be at least some history of the substance in question having been extracted in usable quantities from a plant or a plant-like organism.”

Government lawyers maintained the judge’s interpretation of the law was correct.

“DMAA is a food additive, not a dietary ingredient,” attorneys for FDA and the U.S. Department of Justice (DOJ) wrote in their Jan. 5 appellate brief with the Atlanta-based Eleventh Circuit. “The district court correctly construed the statutory terms … to mean that a ‘constituent’ of a ‘botanical’ is a substance that is physically derived from a plant, not merely a substance that is claimed to be present in the plant in trace amounts but has never been obtained from it.”

To help frame their argument, FDA and DOJ officials noted Merriam-Webster’s Collegiate Dictionary defines the term “constituent” as an “essential part” and identifies “element” as a synonym. In describing a synonym for the word “element,” the dictionary notes “CONSTITUENT stresses its essential and formative character.”

“Even taking the studies cited by Hi-Tech at face value, DMAA is present in geraniums in trace amounts that are so low as to be nearly undetectable, and it has never been physically derived from a geranium,” government lawyers asserted. “In these circumstances, there is no sense in which DMAA can be said to be an ‘essential and formative’ part of a botanical—it was invented by humans and has never been derived from a botanical.”

FDA and DOJ lawyers argued the Eleventh Circuit would need to send the case to the district court if it determines chemicals produced by plants, but not extracted from them, qualify as dietary ingredients. The district court would then have to determine if there is a genuine factual dispute whether geraniums produce DMAA, government lawyers said.

Hi-Tech responded a remand would not be required because the government failed to meet its burden of proof to show DMAA hasn’t been found in geraniums.

“In the relatively few cases in which the FDA will have grounds for banning supplements solely because their ingredients are not constituents of botanicals, the FDA must do what it could not do here: it must offer the courts reliable evidence showing that the substance is not a naturally occurring part of a plant,” Hi-Tech wrote in a Jan. 25 reply brief through its attorneys.

In its opening brief filed last year with the Eleventh Circuit, Hi-Tech said the district court’s interpretation of the law conflicts with “the ordinary meaning" of the term constituent.

“Both now and when Congress enacted DSHEA, the common meaning of ‘constituent’ has been ‘[o]ne part of something that makes up a whole; an element.’ It is a ‘component’ of something else," Hi-Tech stated, quoting Black’s Law and the American Heritage dictionaries. “Nothing in that language suggests that a substance is not a ‘constituent’ of a ‘botanical’ merely because it has not previously been ‘extracted’ from the plant, or because it is not present in some threshold ‘usable’ amount."

Interpretation of key terms in DSHEA like “botanical” and “constituent” is not the only crucial issue dividing the litigants; FDA and Hi-Tech are equally split on whether DMAA is safe.

Scientific studies have showed the substance may cause, or is associated with, significant harmful effects on human health, FDA and DOJ lawyers said. They also referenced a study by the U.S. Department of Defense following the death of several service members who had taken DMAA.

“The report was unable to identify a direct relationship between consuming DMAA and experiencing an adverse medical event,” government lawyers acknowledged, “but the study did find that soldiers who had experienced multiple adverse medical events were more likely (at a statistically significant level) to have consumed DMAA over a prolonged period of time.”

DOJ and FDA also claimed three of Hi-Tech’s own experts “declined to offer an expert opinion that DMAA is generally recognized as safe by scientific experts.”  

Added the government lawyers: “The remainder of their expert opinions came with significant qualifications that undermine Hi-Tech’s claim that DMAA is generally recognized as safe.”

Hi-Tech, however, insisted its experts did, in fact, offer assessments that DMAA was GRAS. The company previously said several of its experts rejected the premise that DMAA was unsafe when taken at the recommended doses in its products, and the supplement company argued the judge misapplied the law.

“The critical statutory text from the GRAS provision shows that manufacturers need not establish that the substance at issue is generally recognized as safe for all conceivable uses," the company wrote in its opening brief. “The manufacturer instead must demonstrate that the substance is safe ‘under the conditions of its intended use.’"

Under DSHEA, FDA faces the burden of establishing an ingredient like DMAA is adulterated, and the Hi-Tech appeal underscores the process can be an extremely long one for the government.

In 2013, FDA administratively detained millions of dollars in DMAA-containing products following an inspection of Hi-Tech’s facilities. But throughout litigation in the district court and even following entry of Hunt’s summary judgment order, Hi-Tech continued to sell DMAA-containing products.

As part of an agreement to secure his release from custody after being arrested on the unrelated criminal charges, Wheat agreed in October 2017 to stop selling products containing DMAA.

The accord marked a victory for FDA in its years-long efforts—beginning with 2012 warning letters—to remove from supplements what is considers an unsafe ingredient.

Lawyers for Wheat described the halt on DMAA-containing sales as “devastating to Hi-Tech’s business,” and they argued their client reached the agreement under duress.

Jack Wenik, a lawyer representing Hi-Tech with Epstein Becker & Green P.C., said he expects the Eleventh Circuit to hear oral arguments in the case.

The case is on appeal from the U.S. District Court for the Northern District of Georgia, No. 1:13-cv-03675-WBH.