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United States v. Undetermined Quantities of All Articles of Finished And In-Process Foods

United States Court of Appeals, Eleventh Circuit

August 30, 2019

UNITED STATES OF AMERICA, Plaintiff - Appellee,
v.
UNDETERMINED QUANTITIES OF ALL ARTICLES OF FINISHED AND IN-PROCESS FOODS, raw ingredients (bulk powders, bulk capsules), with any lot number, size, or type container, whether labeled or unlabeled, et al., Defendants, HI-TECH PHARMACEUTICALS, INC., JARED WHEAT, Claimants - Appellants.

          Appeal from the United States District Court for the Northern District of Georgia D.C. Docket No. 1:13-cv-03675-WBH

          Before TJOFLAT and JORDAN, Circuit Judges, and HINKLE, [*] District Judge.

          HINKLE, DISTRICT JUDGE

         The Dietary Supplement Health and Education Act of 1994 provides favorable treatment for "dietary supplements," defined to include any "botanical" or "constituent" of a botanical. This case presents the question whether these terms apply to a substance that was invented in a laboratory and is artificially produced for commercial sale but that, entirely coincidentally, may be found in trace amounts in a plant. We hold that the terms do not extend this far.

         I. Proceedings

         The Food and Drug Administration seized from Hi-Tech Pharmaceuticals, Inc. a substantial quantity of products containing 1, 3-dimethylamylamine or "DMAA." DMAA is used in fitness products aimed at bodybuilders and other athletes.

         The seizure led to two actions that were consolidated in the district court. One was a forfeiture action filed by the United States against the products. Hi-Tech and its chief executive officer, Jared Wheat, intervened as claimants. Hi-Tech filed the other action against the FDA and other governmental defendants.

         Hi-Tech asserted that DMAA is a dietary supplement; that under the Administrative Procedure Act the FDA can properly ban DMAA, if at all, only through rulemaking; and that the seizure of Hi-Tech's DMAA violated the Fifth Amendment's Due Process Clause.

         The parties filed cross-motions for summary judgment. The district court granted the FDA's motion, holding the seizure proper both substantively and procedurally. The district court denied a motion to reconsider that included a request to reopen discovery. Hi-Tech and Mr. Wheat have appealed. The appeal has been fully briefed and orally argued.

         II. Standard of Review

         We review de novo the district court's grant of summary judgment. See, e.g., Price v. Comm'r, Dep't of Corr., 920 F.3d 1317, 1323 (11th Cir. 2019). We review for abuse of discretion the district court's denial of the motion for reconsideration and refusal to reopen discovery. See, e.g., Corwin v. Walt Disney Co., 475 F.3d 1239, 1254 (11th Cir. 2007) (reconsideration); Artistic Entm't, Inc. v. City of Warner Robins, 331 F.3d 1196, 1202 (11th Cir. 2003) (reopening discovery).

         III. The Statute and the Issues

         The Federal Food, Drug, and Cosmetic Act prohibits the introduction of adulterated foods into interstate commerce. 21 U.S.C. § 331(a). The FDA enforces the Act. Id. § 393(b)(2)(A). The agency may bring an in rem forfeiture action in district court to condemn adulterated foods. Id. § 334(a)(1). Hi-Tech's DMAA products were adulterated foods if they were "food additives" but not if they were "dietary supplements."

         The background is this. The Dietary Supplement Health and Education Act of 1994, commonly referred to as "DSHEA," amended the Federal Food, Drug, and Cosmetic Act to provide favorable treatment for dietary supplements. The statute's definition of "dietary supplement" includes multiple parts. 21 U.S.C. § 321(ff). The only part relevant to Hi-Tech's DMAA is this: a product that is intended to supplement the diet-this includes DMAA-is a dietary supplement if it contains "an herb or other botanical" or "a concentrate, metabolite, constituent, extract, or combination of" an herb or other botanical. Id. § 321(ff)(1)(C) & (F). The statute describes these-as well as other substances not at issue here-as "dietary ingredients."

         Under DSHEA, and subject to exceptions not relevant here, a dietary supplement can be condemned as adulterated only if the FDA carries the burden of proving that the substance presents a "significant or unreasonable risk of illness or injury" under recommended, suggested, or ordinary conditions of use. Id. § 342(f)(1)(A). The FDA did not attempt to make that showing for the DMAA products it seized from Hi-Tech. A ruling that DMAA is a dietary supplement thus would resolve this appeal in Hi-Tech's favor.

         On the other hand, a ruling that DMAA is a "food additive" would resolve the dispute in the FDA's favor. A substance intended for human consumption is a food additive if it is not a dietary supplement and is not "generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures . . . to be safe under the conditions of its intended use." Id. § 321(s). For a substance in common use in food prior to January 1, 1958-this does not include DMAA-the adequate showing of safety can be made not only by scientific procedures but also by experience. There are other exceptions to this definition of "food additive," but none applies here.

         The FDA asserts that DMAA is not a dietary supplement, is not generally recognized as safe, does not meet any other exception, and is therefore a food additive. Hi-Tech insists that DMAA is a dietary supplement and thus is not a food additive, but that even if DMAA is not a dietary supplement, DMAA is generally recognized as safe and thus still is not a food additive.

         The issues thus are first, whether Hi-Tech's DMAA products are "an herb or other botanical" or "a concentrate, metabolite, constituent, extract, or combination of" an herb or other botanical, and second, if not, whether the products are generally recognized as safe. Secondary issues are whether the FDA was entitled to seize and forfeit the products without engaging in rulemaking and whether the district court should have reopened discovery.

         IV. DMAA

         The earliest known identification or use of DMAA occurred in 1944. In that year Eli Lilly & Co. synthesized and patented DMAA for use as a nasal decongestant. For marketing reasons, Eli Lilly asked the FDA to withdraw its approval of this use in 1983. At least insofar as shown by this record, DMAA was not used as a dietary supplement or food additive at that time, and no health concerns had been noted.

         DMAA eventually made a resurgence, this time in fitness products aimed at bodybuilders and other athletes. Because of DMAA's noticeable stimulant effect, the compound made its way into pre-workout energy and fat-burner products around the world.

         The FDA eventually adopted the position that DMAA is not a dietary supplement but an unsafe food additive. The FDA issued cease-and-desist letters to at least some entities marketing DMAA products. Perhaps unaware of Hi-Tech's marketing of DMAA products, the FDA did not issue a cease-and-desist letter to Hi-Tech.

         Around the same time, researchers began to find trace amounts of DMAA in geraniums of the genus pelargonium. A 2013 survey concluded that overall, the studies showed that DMAA "is found naturally in some, but not all, geranium plants and extracted geranium oils." Thomas D. Gauthier, Evidence for the Presence of 1, 3-Dimethylamylamine (1, 3-DMAA) in Geranium Plant Materials, 8 Analytical Chemistry Insights 29-40 (2013), available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3682735/. Indeed, the FDA's own expert had previously participated in a study that found trace amounts of DMAA in geraniums.

         Even so, this record presents a genuine factual dispute over whether trace amounts of DMAA are naturally contained in geraniums. On the one hand, studies have found trace amounts of DMAA in geraniums. On the other hand, some fertilizers contain DMAA that could be a source of trace amounts of DMAA in geraniums, and the record includes competent testimony that there is no known pathway by which geraniums could produce DMAA. Either way, it is clear that DMAA is not ...


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