11th Circuit Hears Supplement Maker’s Fight With Feds

ATLANTA (CN) — Attorneys for a dietary supplement manufacturer asked the 11th Circuit on Friday to overturn a district court ruling which found that the U.S. government rightfully seized $2.2 million worth of a supplement ingredient.

Hi-Tech Pharmaceuticals has been engaged in a legal battle with the U.S. Food and Drug Administration since 2013, when the agency seized supplements manufactured by Hi-Tech that contained the stimulant DMAA.

DMAA is said to have an energy-boosting effect similar to caffeine and can supposedly be derived from geranium plants. It is used by Hi-Tech as an ingredient in weight loss and bodybuilding supplements.

Before the FDA seizure, Hi-Tech says it sold over 3 million units of DMAA-containing supplements in the five years after it started marketing them.

But the FDA holds that DMAA is not, in fact, present in geraniums.

The agency claims that Hi-Tech failed to demonstrate that there is a consensus among scientific experts that the ingredient is safe for human consumption.

Last October, a federal judge found that the supplement maker and its CEO Jared Wheat violated a Federal Trade Commission injunction by making misleading claims about four weight loss supplements. The court entered a judgment imposing sanctions of over $40 million against Wheat, Hi-Tech and a company vice president.

The questions surrounding DMAA’s safety are exacerbated by the 2011 deaths of four U.S. soldiers. They died after exercising and were found to have traces of DMAA in their blood, prompting the Department of Defense to remove all products containing DMAA from military exchanges and concession stores.

A department report could not identify a link between DMAA and health problems, but did find that soldiers who suffered from existing health problems were twice as likely to have used DMAA.

Hi-Tech has called the FDA’s seizure of the ingredient “an extreme act of overreach” and claims that the government violated the Administrative Procedure Act and due-process clause of the Fifth Amendment.

After the company challenged the seizure, the government filed an action seeking forfeiture of the supplements under the Federal Food, Drug, and Cosmetic Act and an amendment to that law known as the Dietary Supplement Health and Education Act.

Under the statutes, the FDA treats dietary supplements as food and places the burden of proof on the government to prove that a product is unsafe before it can be removed from the marketplace.

According to the law, dietary supplements fall under three categories: dietary ingredients, food additives, and substances that are not dietary ingredients but which have been “generally recognized as safe.” Dietary ingredients must be vitamins, minerals, amino acids, herbs or other botanicals, or a constituent of those.

If a substance is designated a dietary ingredient, it is presumed to be safe and manufacturers are allowed to market and sell it without FDA pre-approval.

Hi-Tech claims that DMAA qualifies as a dietary ingredient because it is a “constituent,” or extract, of a geranium plant.

But the company has only argued that DMAA has been detected in geranium plants, and has acknowledged that the DMAA in its supplements is synthetic. It has never made DMAA by extracting it directly from geranium plants, although it claims to have filed two patent applications for DMAA extraction processes.

A federal judge ruled in favor of the government in April 2017, finding that the safety of DMAA is in question and that it is a food additive rather than a dietary ingredient.

Attorneys for Hi-Tech argued in front of an 11th Circuit panel Friday that the district court misinterpreted the Dietary Supplement Health and Education Act and incorrectly defined the terms “constituent” and “botanical” in its analysis.

“The district court misinterpreted the words ‘constituent’ and ‘botanical’ in a way that the text [of the law] won’t bear,” attorney John Neiman, Jr. argued for the company.

“Your position is that the term ‘dietary ingredient’ means any substance found in flora or any identical substance manufactured in a lab?” asked Senior U.S. Circuit Judge Robert Hinkle.

“Yes, that’s exactly right. That definition is broad, but that was Congress’ intention—to allow dietary supplement manufacturers to use a variety of [ingredients],” Neiman replied.

Attorneys representing the government staunchly refuted those arguments, telling the 11th Circuit panel that DMAA is, at a minimum, unsafe.

“The district court’s interpretation is correct. No reasonable fact finder could find DMAA in geraniums,” attorney Daniel Aguilar said, pointing out that experts have found the stimulant in geraniums at only “365 parts per billion by best evidence.”

But the panel seemed more focused on concerns that the lower court may have abused its discretion by focusing its findings on the fact that DMAA has not been extracted from geraniums before.

“The district court said there had to be a history of extraction. [The government] had not proposed that standard. In order to show history, you have to do discovery. If [the district court] came up with that without you, if that issue wasn’t teed up by either side, why wasn’t Hi-Tech allowed to prove otherwise?” U.S. Circuit Judge Adalberto Jordan asked.

Jordan continued, “If the district court had come up with a legal theory that Hi-Tech had not advanced and granted summary judgment to Hi-Tech, would you have appealed? You would’ve been incensed that a district court had come up with a legal theory that neither of you had advanced. You would’ve been up here in a heartbeat.”

“This notion that it has to have been extracted—let’s say a tree trunk is 50 percent magic dust but nobody has harvested it and made any supplement with it and someone makes a process to do so – why isn’t this… the test? I can’t find in the statute that it has to have been done,” Judge Hinkle asked.

“The dust would be a food additive because it’s never been derived,” Aguilar replied.

In rebuttal, Neiman argued the case is still ripe for summary judgment and the district court’s judgment should be reversed.

“All evidence shows DMAA is in geraniums,” he argued. “The government did not satisfy its burden of showing it’s not.”

The judges did not indicate when they might issue a decision in the case.

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