By Nicole D. Prysby, J.D.
DMAA products (containing 1,3-dimethylamylamine) are not dietary supplements, because the DMAA in the products is synthesized and not derived from a plant. Because DMAA is not generally recognized as safe, it is classified as a food additive.
The favorable treatment for "dietary supplements" provided in the Dietary Supplement Health and Education Act (DSHEA) (P.L. 103-417) does not 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, held the Eleventh Circuit Court of Appeals. The DSHEA’s use of the word "botanical" in the definition of dietary supplement means a substance derived from a plant, not all plant life and it is unlikely that Congress used the term "herb or other botanical" to mean a substance invented in a laboratory and artificially produced (U.S. v. Undetermined Quantities of All Articles of Finished and In-Process Foods, August 30, 2019, Hinkle, R.).
Products. The FDA seized from Hi-Tech Pharmaceuticals, Inc. (Hi-Tech) products containing 1,3-dimethylamylamine or DMAA, a synthesized substance used in fitness products aimed at bodybuilders. Hi-Tech asserted that DMAA is a dietary supplement. Under the federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq), Hi-Tech’s DMAA products were adulterated foods (and thus, validly seized by the FDA) if they were "food additives" but not if they were "dietary supplements."
The court concluded that the DMAA is not a dietary supplement and is not generally recognized as safe, and is therefore a food additive. Hi-Tech’s DMAA products are not a dietary supplement, because they are not "an herb or other botanical" under the DSHEA. DMAA is found naturally in trace amounts in some geranium plants. But the DSHEA’s use of the word "botanical" means a substance derived from a plant, not all plant life. It is unlikely that Congress used the term "herb or other botanical" to mean a substance invented in a laboratory and artificially produced, that can be found in a plant only in trace amounts, only coincidentally, and that has never been derived from a plant for use in any medicinal, cosmetic, or dietary product.
Further evidence for this conclusion is shown by the purpose underlying the preference for dietary supplements. A rebuttable presumption for anything derived from a plant serves administrative convenience and avoids delay in introducing a product to the market. It is a stretch, though, to apply the same reasoning to a substance invented in a laboratory and artificially produced. The FDA demonstrated that DMAA is not generally recognized as safe among qualified experts based on adequate studies. Therefore, DMAA is a food additive.
The court also upheld the district court’s denial of Hi-Tech’s motion to reopen discovery. Although the court did not fully adopt the position taken by either side, regardless of whether Hi-Tech recognized or should have recognized that a court might find actual derivation critical, Hi-Tech had every incentive to fully develop the facts on this during the original discovery period.
The case is No. 17-13376.
Attorneys: Daniel J. Aguilar, U.S. Department of Justice, for the United States. Scott Samuel Brown (Maynard, Cooper & Gale, P.C.) for Hi-Tech Pharmaceuticals, Inc.
Companies: Undetermined Quantities of All Articles of Finished and In-Process Foods; Hi-Tech Pharmaceuticals, Inc.
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