SCOTUS Declines FDA Dietary Supplement Classification Case

On Monday, the Supreme Court of the United States denied a petition for a writ of certiorari filed by Hi-Tech Pharmaceuticals, Inc. and Jared Wheat, who appealed from a defeat in the 11th Circuit Court of Appeals. The petitioners questioned whether the Food and Drug Administration (FDA) correctly determined that a Hi-Tech dietary supplement contained an unsafe ingredient. The Sept. 1 petition asked the court to review the decision of a divided 11th Circuit panel, finding that the FDA’s decision was both correct and within its regulatory purview.

The case began after the FDA seized millions of dollars’ worth of 1,3-dimethylamylamine or DMAA-containing dietary supplements from Hi-Tech. This followed the agency’s 2013 determination that DMAA posed health risks to consumers. The agency then initiated a forfeiture proceeding in the Northern District of Georgia. Subsequently, Hi-Tech and the company’s main owner and CEO, Jared Wheat, intervened as claimants.

The legal issues centered on the interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA). According to the petitioners, the law allows manufacturers to “sell supplements, without first obtaining FDA approval, if their ingredients are, among other things, ‘constituents’ of ‘herbs or other botanicals.’”

The DMAA in Hi-Tech’s dietary supplements, they argued, occurred naturally in geranium plants, thereby meeting the statutory definition as a constituent of an herb or other botanical. In turn, they contended, they did not need regulatory approval to sell the supplements, and the FDA’s seizure was improper. The FDA disagreed.

The District of Georgia court sided with the government. The appellate court affirmed, holding that “DMAA is not an ‘herb or other botanical.’ 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.”

According to the petition, the courts reasoned that studies showing DMAA’s natural occurrence in geranium, even if accurate, does not as a matter of law render DMAA a constituent of a botanical because “these studies show that DMAA appears in geraniums only in trace quantities, and DMAA has no prior history of being directly extracted from the plant for medicinal, cosmetic, or dietary use.”

The petitioners posed the following question to the Supreme Court, “[d]id the 11th Circuit err in holding that a substance that naturally occurs in a plant is not a ‘constituent’ of an ‘herb or other botanical’ — and therefore cannot be included in presumptively marketable dietary supplements under the Dietary Supplement Health and Education Act — if the substance naturally occurs in the plant only in trace quantities and has no prior history of being extracted from the plant for medicinal, cosmetic, or dietary use?”

They argued that the “FDA’s theory as to why these supplements were not marketable shifted throughout the litigation,” and the agency eventually “prevailed on a ground that was distinct from the one the agency first advanced to seize these products.” 

Additionally, they contended that the 11th Circuit “placed artificial restraints on plain text found in the Dietary Supplement Health and Education Act and adopted, in the place of the most straightforward reading of the statute’s language, what the court deemed to be the ‘safest conclusion’ about what Congress would have wanted if it had been confronted with the specific facts of the case.” The petitioners also echoed the opinion of dissenting Judge Adalberto Jordan, criticizing the majority’s decision as based on policy concerns rather than “DSHEA’s plain text and the ordinary understanding” of the terms at issue.

The petitioners are represented by Maynard Cooper & Gale, P.C.