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`No. __________
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`In the
`Supreme Court of the United States
`──────────────────────────
`HI-TECH PHARMACEUTICALS, INC. AND JARED WHEAT,
`Petitioners,
`v.
`FOOD & DRUG ADMINISTRATION, ET AL.,
`Respondent.
`
`──────────────────────────
`On Petition for a Writ of Certiorari to the
`United States Court of Appeals for the Eleventh Circuit
`──────────────────────────
`PETITION FOR A WRIT OF CERTIORARI
`──────────────────────────
`
`John C. Neiman, Jr.
` Counsel of Record
`Thomas W.H. Buck, Jr.
`Brandt P. Hill
`MAYNARD COOPER & GALE, P.C.
`1901 Sixth Avenue North
`2400 Regions/Harbert Plaza
`Birmingham, AL 35203
`(205) 254-1228
`jneiman@maynardcooper.com
`
`Counsel for Petitioners
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`September 1, 2020
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`i
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`QUESTION PRESENTED
` To increase the dietary supplements available to
`the public, the Dietary Supplement Health and Edu-
`cation Act of 1994 (“DSHEA”), 21 U.S.C. §321(ff),
`amended the Federal Food, Drug, and Cosmetic Act.
`DSHEA’s amendments allow manufacturers to sell
`supplements, without first obtaining FDA approval, if
`their ingredients are, among other things, “constitu-
`ent[s]” of “herb[s] or other botanical[s].” 21 U.S.C.
`§321(ff)(1)(C) & (F). The dietary supplements at issue
`in this case contain an ingredient known as DMAA,
`which studies have shown occurs in geranium plants.
`The courts below held that, even if these studies are
`accurate, DMAA is not, as a matter of law, a “constit-
`uent” of a “botanical”—and thus is not presumptively
`marketable as an ingredient in dietary supplements
`under DSHEA—because these studies show that
`DMAA appears in geraniums only in trace quantities,
`and DMAA has no prior history of being directly ex-
`tracted from the plant for medicinal, cosmetic, or die-
`tary use. The question presented is as follows:
`
`
`Did the Eleventh 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 presump-
`tively 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?
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`ii
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`PARTIES TO THE PROCEEDINGS
`Petitioners Hi-Tech Pharmaceuticals, Inc. and
`Jared Wheat were appellants below. Respondents
`United States Food and Drug Administration, United
`States Department of Health and Human Services,
`and United States of America were appellees below.
`Respondent Alex Azar, in his official capacity as Sec-
`retary of the Department of Health and Human Ser-
`vices, succeeded to that office on January 29, 2018, at
`which time Secretary Azar was automatically substi-
`tuted as a party under Federal Rule of Appellate Pro-
`cedure 43(c)(2). Upon assuming office, Secretary Azar
`was an appellee below. Respondent Stephen M. Hahn,
`in his official capacity as Commissioner of the United
`States Food and Drug Administration, succeeded to
`that office on December 17, 2019, after the entry of
`judgment below, at which time Commissioner Hahn
`was automatically substituted as a party under Fed-
`eral Rule of Appellate Procedure 43(c)(2).
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`iii
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`CORPORATE DISCLOSURE STATEMENT
` Hi-Tech Pharmaceuticals, Inc. is not a publicly
`traded company. It has no parent company, and no
`company owns 10% or more of its stock.
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`iv
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`RELATED PROCEEDINGS
` This case arises from the following proceedings in
`the United States District Court for the District of Co-
`lumbia, the United States District Court for the
`Northern District of Georgia, and the United States
`Court of Appeals for the Eleventh Circuit, listed here
`in chronological order:
`Hi-Tech Pharmaceuticals, Inc. v. Hamburg, No. 1:13-
`CV-01747 (D.D.C.) (transferred to N.D. Ga. Aug. 1,
`2014).
`Hi-Tech Pharmaceuticals, Inc. v. Hamburg, No. 1:14-
`CV-24790-WBH (N.D. Ga.) (merged into No. 1:13-CV-
`0675-WBH Aug. 1, 2014).
`United States of America v. Undetermined Quantities
`of All Articles of Finished and In-Process Foods, No.
`1:13-CV-03675-WBH (N.D. Ga. Apr. 3, 2017), availa-
`ble at 2017 WL 4456903.
`United States of America v. Undetermined Quantities
`of All Articles of Finished and In-Process Foods, No.
`17-13376 (11th Cir. Aug. 20, 2019), reported at 936
`F.3d 1341.
`
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`v
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`TABLE OF CONTENTS
`Question Presented ..................................................... i
`Parties to the Proceedings ......................................... ii
`Corporate Disclosure Statement .............................. iii
`Related Proceedings ................................................... iv
`Table of Appendices.................................................. vii
`Table of Authorities ................................................. viii
`Petition for a Writ of Certiorari .................................. 1
`Opinions Below ............................................................ 5
`Statement of Jurisdiction............................................ 6
`Statutory Provisions Involved .................................... 7
`Statement of the Case ................................................. 8
`A.
`DSHEA’s regulatory structure ................... 8
`B.
`DMAA’s presence
`in geranium
`plants ......................................................... 10
`The FDA’s shifting positions on
`DMAA ........................................................ 11
`The District Court’s ruling ........................ 13
`D.
`Reasons This Court Should Grant Certiorari .......... 18
`The Eleventh Circuit’s interpretation
`A.
`of DSHEA
`is wrong
`and
`fundamentally
`contrary
`to
`the
`principles set forth in Bostock .................. 19
`
`C.
`
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`vi
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`B.
`
`The Eleventh Circuit’s rewriting of
`DSHEA is important and worthy of
`review ......................................................... 26
`Conclusion ................................................................. 31
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`vii
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`TABLE OF APPENDICES
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`Page
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`A P P E N D I X A — O P I N I O N O F T H E
`UNITED STATES COURT OF APPEALS
`FOR THE ELEVENTH CIRCUIT, FILED
`AUGUST 30, 2019 ........................................................... 1a
`
`A P P E N D I X B — O R D E R D E N Y I N G
`RECONSIDERATION IN THE UNITED
`S T A T E S D I S T R I C T C O U R T F O R
`T H E N O R T H E R N D I S T R I C T O F
`GEORGIA, ATLANTA DIVISION, FILED
`JUNE 2, 2017 ................................................................27a
`
`APPENDIX C — ORDER OF THE UNITED
`S T A T E S D I S T R I C T C O U R T F O R
`T H E N O R T H E R N D I S T R I C T O F
`GEORGIA, ATLANTA DIVISION, FILED
`APRIL 3, 2017 ...............................................................30a
`
`A P P E N D I X D — O R D E R D E N Y I N G
`REHEARING IN THE UNITED STATES
`C O U R T O F A P P E A L S F O R T H E
`E L E V E N T H C I R C U I T , F I L E D
`APRIL 8, 2020 ...............................................................43a
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`viii
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`TABLE OF AUTHORITIES
`
`CASES
`Bostock v. Clayton County, Georgia,
`140 S. Ct. 1731 (2020) .... 1, 3, 18, 23, 24, 26, 30
`Loughrin v. United States,
`573 U.S. 351 (2014)......................................... 23
`Nutraceutical Corp. v. Von Eschenbach,
`459 F. 3d 1033 (C.A.10 2006) ......................... 29
`Oncale v. Sundowner Offshore Servs., Inc.,
`523 U.S. 75 (1998) .......................................... 23
`Pa. Dep’t of Corrections v. Yeskey,
`524 U.S. 206 (1998)........................................... 3
`Sedima, S. P. R. L. v. Imrex Co.,
`473 U. S. 479 (1985).................................... 3, 24
`
`STATUTES
`15 U.S.C. §2697 ......................................................... 21
`21 U.S.C. §321(ff) ............................... i, 1, 2, 7, 8, 9, 20
`21 U.S.C. §334 ............................................................. 6
`21 U.S.C. §342 ....................................................... 9, 25
`21 U.S.C. §355 ............................................................. 8
`28 U.S.C. §1254 ........................................................... 6
`28 U.S.C. §1291 ........................................................... 6
`
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`ix
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`
`28 U.S.C. §1345 ........................................................... 6
`Dietary Supplement Health and Education
`Act of 1994,
`Pub. L. No. 103-417,
`108 Stat. 4325 (1994) ........................................ 9
`
`RULES OF PROCEDURE
`Fed. R. App. P. 43 ...................................................... iii
`
`REGULATIONS
`21 C.F.R. §101.13 ........................................................ 8
`21 C.F.R. §101.14 ........................................................ 8
`21 C.F.R. §101.70 ........................................................ 8
`Rule Declaring Dietary Supplements
`Containing Ephedrine Alkaloids
`Adulterated,
`69 Fed. Reg. 6787 (2004) ................................ 29
`
`ARTICLES AND PAPERS
`Bass, Scott, et al.,
`The New Dietary Ingredient Safety
`Provision of DSHEA: A Return to
`Congressional Intent,
`31 AM. J.L. & MED. 285 (2005) ....................... 25
`Batra, Sukhsatej,
`Importance of Trace Elements in the
`
`
`
`
`
`
`
`x
`
`
`
`Human Body,
`S.F. CHRON. (Dec. 12, 2018) ............................ 21
`Buie, John,
`Evolution of Mass Spectrometers,
`LAB MANAGER (Feb. 27, 2011) ........................ 28
`ElSohly, Mahmoud A., et al.,
`Pelargonium Oil and Methyl
`Hexaneamine (MHA): Analytical
`Approaches Supporting the Absence of
`MHA in Authenticated Pelargonium
`Graveolens Plant Material and Oil,
`J. ANALYTICAL TOXICOLOGY 1 (2012) .............. 12
`ElSohly, Mahmoud A., et al.,
`Methylhexanamine is Not Detectable
`in Pelargonium or Geranium Species
`and Their Essential Oils: A
`Multicentre Investigation,
`DRUG TESTING & ANALYSIS (2014) .................. 12
`Fleming, HL, et al.,
`Analysis and Confirmation of 1,3-
`DMAA and 1,4-DMAA in Geranium
`Plants Using High Performance
`Liquid Chromatography with
`Tandem Mass Spectrometry at ng/g
`Concentrations,
`7 ANALYTICAL CHEMISTRY INSIGHTS 59
`(2012) ............................................................... 10
`Gauthier, Thomas D.,
`Evidence for the Presence of 1,3-
`Dimethylamylamine (1,3-DMAA) in
`
`
`
`
`
`
`
`xi
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`
`
`Geranium Plant Materials,
`8 ANALYTICAL CHEMISTRY INSIGHTS 29
`(2013) ............................................................... 10
`Li, J.S., et al.,
`Identification and Quantification of
`Dimethylamylamine in Geranium by
`Liquid Chromatography Tandem
`Mass Spectrometry,
`7 ANALYTICAL CHEMISTRY INSIGHTS 47
`(2012) ............................................................... 10
`McCormack, Denise, et al.,
`A Review of Pterostilbene Antioxidant
`Activity and Disease Modification,
`OXIDATIVE MEDICINE & CELLULAR
`LONGEVITY (2013) ........................................... 27
`McNulty, James,
`A scalable process for the synthesis of
`(E)-pterostilbene involving aqueous
`Wittig olefination chemistry,
`SCIENCE DIRECT J. (May 2013) ....................... 27
`Oregon State Univ. Linus Pauling Inst.,
`Micronutrient Info. Ctr.: Resveratrol
`(2015) ............................................................... 27
`Ping, Zang, et al.,
`A Study on the Chemical Constituents
`of Geranium Oil,
`25 J. GUIZHOU INST. TECH. 82 (1996) .............. 10
`Scientists Discover a Cancer-Fighting
`Substance in a Common Wildflower,
`SILICON REPUBLIC (Aug. 2, 2019) ................... 28
`
`
`
`
`
`
`
`xii
`
`
`Smith, Timothy P.,
`Hidden Worlds: Hunting for Quarks
`in Ordinary Matter (PRINCETON UNIV.
`PRESS 2003) ..................................................... 22
`Yirka, Bob,
`Chemists Figure Out How to
`Synthesize Compounds from
`Resveratrol,
`PHYSORG.COM (June 23, 2011) ....................... 27
`Zhang, Ying, et al.,
`1,3 Dimethylamylamine (DMAA) in
`Supplements and Geranium
`Products: Natural or Synthetic?,
`DRUG TESTING ANALYSIS (2012) ..................... 13
`
`DICTIONARIES
`MERRIAM-WEBSTER ONLINE DICTIONARY
`(2019) ............................................................... 21
`SHORTER OXFORD ENGLISH DICTIONARY (5th
`ed. 2002) .......................................................... 19
`WEBSTER’S THIRD NEW INTERNATIONAL
`DICTIONARY OF THE ENGLISH
`LANGUAGE UNABRIDGED (2002) ...................... 20
`
`
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`1
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`
`PETITION FOR A WRIT OF CERTIORARI
`Just this past Term in Bostock v. Clayton County,
`Georgia, 140 S. Ct. 1731 (2020), this Court empha-
`sized that a statute’s unambiguous text governs even
`when it yields a result, as applied to a particular fac-
`tual setting, that a court suspects Congress might not
`have anticipated. In this case—decided before Bos-
`tock—the Eleventh Circuit did what Bostock said
`courts must not do. The Eleventh Circuit placed arti-
`ficial 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. App. A at 11a. The Eleventh Circuit’s de-
`cision is at odds with DSHEA and the overarching
`principles that govern statutory interpretation, and
`the issue presented is of great import to the dietary-
`supplement industry. This case thus would be worthy
`of review even if this Court had not decided Bostock in
`the meantime. But Bostock at least makes it appropri-
`ate to grant certiorari, to vacate the Eleventh Circuit’s
`judgment, and to remand for that court to reconsider
`its reading of DSHEA.
` The statutory-interpretation question in this case
`is whether a chemical compound Petitioners syntheti-
`cally produce for inclusion in dietary supplements—
`1,3-dimethylamylamine, known as DMAA—is a “con-
`stituent” of an “herb or other botanical” under
`§321(ff)(1)(F) of DSHEA. If so, then DSHEA makes it
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`2
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`a “dietary ingredient,” which manufacturers may in-
`corporate into dietary supplements without first seek-
`ing and obtaining the FDA’s approval. The District
`Court and a divided Eleventh Circuit both held, on the
`Government’s motion for summary judgment, that
`DMAA is not a “constituent” of an “herb or other bo-
`tanical” as a matter of law. But under any reasonable
`interpretation of DSHEA’s language, Petitioners are
`entitled to a trial. The Eleventh Circuit recognized
`that this record reveals “a genuine factual dispute
`over whether trace amounts of DMAA are naturally
`contained in geranium[]” plants. App. A at 7a. Every-
`one agrees that the geraniums in which DMAA has
`been found are “herb[s] or other botanical[s].” 21
`U.S.C. §321(ff)(1)(C). Yet the Eleventh Circuit major-
`ity concluded that, even if DMAA naturally occurs in
`geraniums, it is not a “constituent” of an “herb or other
`botanical.”
`As Judge Jordan noted in his dissent, that result
`was driven not by DSHEA’s plain text and the ordi-
`nary understanding of the terms “constituent,” “herb,”
`and “botanical,” but instead by the majority’s “policy”
`concerns. App. A at 25a. The majority theorized that
`DSHEA makes constituents of herbs or other botani-
`cals marketable because “consuming them is ordinar-
`ily safe” and posited that “[t]he fact that DMAA can
`be found in trace amounts in geraniums, if true, says
`absolutely nothing about whether consuming the sub-
`stance is safe.” App. A at 11a, 12a. On that basis the
`majority read words into DSHEA, requiring not only
`that the compound be a “constituent” of an “herb or
`other botanical,” but also that it be present in more
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`3
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`than “trace amounts,” and that it have a prior history
`of being “derived” from the plant for “medicinal, cos-
`metic, or dietary” products. App. A at 12a. It was of no
`consequence to the majority that the phrases “trace
`amounts,” “derived,” and “medicinal, cosmetic, or die-
`tary” appear nowhere in the statutory text.
`Bostock makes clear that the Eleventh Circuit’s
`reasoning cannot stand. Judge Jordan’s dissent in-
`voked almost precisely the same language this Court
`would use 10 months later in Bostock: “[T]he fact that
`a statute can be applied in situations not expressly
`anticipated by Congress does not demonstrate ambi-
`guity. It demonstrates breadth.” App. A at 26a (quot-
`ing Pa. Dep’t of Corrections v. Yeskey, 524 U.S. 206,
`212 (1998)); cf. Bostock, 140 S. Ct. at 1749 (“But ‘ “the
`fact that [a statute] has been applied in situations not
`expressly anticipated by Congress” ’ does not demon-
`strate ambiguity; instead, it simply ‘ “demonstrates
`[the] breadth” ’ of a legislative command.” (quoting
`Sedima, S. P. R. L. v. Imrex Co., 473 U. S. 479, 499
`(1985)). DSHEA’s language broadly encompasses all
`constituents of botanicals—including those that, like
`DMAA, appear in plants only in trace quantities and
`have not previously been extracted for medicinal, cos-
`metic, or dietary purposes. That should have been dis-
`positive.
`The need for this Court to correct the Eleventh Cir-
`cuit’s misinterpretation is paramount, for a great deal
`is at stake. DSHEA’s drafters recognized that dietary
`supplements are an important food source, and the
`Eleventh Circuit’s decision will stifle innovation in the
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`industry. The FDA’s record in attempting to take Pe-
`titioners’ DMAA-containing supplements off the mar-
`ket raises serious concerns about regulatory over-
`reach. If this Court does not grant plenary review, it
`should at least grant certiorari, vacate the Eleventh
`Circuit’s judgment, and remand for further consider-
`ation in light of Bostock.
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`4
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`OPINIONS BELOW
`The Eleventh Circuit’s opinion is reported as
`United States v. Undetermined Quantities of All Arti-
`cles of Finished and In-Process Foods, 936 F.3d 1341
`(C.A.11 2019), and reproduced at App. A at 1a–26a.
`The District Court’s unpublished opinion granting the
`Government summary judgment is reproduced at
`App. C at 30a–42a. The District Court’s unpublished
`opinion denying Hi-Tech and Jared Wheat’s motion
`for reconsideration is reproduced at App. B at 27a-
`29a. The Eleventh Circuit’s unpublished order deny-
`ing panel and en banc rehearing is reproduced at App.
`D at 43a–44a.
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`5
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`STATEMENT OF JURISDICTION
` The decision under review arose from an in rem
`forfeiture action the United States filed against the
`dietary supplements at issue here. Hi-Tech and its
`CEO, Jared Wheat, intervened as claimants in that
`action. The District Court had jurisdiction under 28
`U.S.C. §1345, which gives “the district courts . . . orig-
`inal jurisdiction of all civil actions, suits or proceed-
`ings commenced by the United States,” and 21 U.S.C.
`§334(a)(1), which provides that the Government may
`proceed with Food, Drug, and Cosmetic Act condem-
`nation actions “in any district court of the United
`States or United States court of a Territory within the
`jurisdiction of which the article is found.”
`The District Court entered final judgment, finding
`the DMAA-containing supplements subject to forfei-
`ture. App. C at 42a; App. B at 27a–29a. Hi-Tech and
`Wheat took a timely appeal, and the Eleventh Circuit
`had jurisdiction under 28 U.S.C. §1291. The panel en-
`tered final judgment, affirming the summary judg-
`ment, on August 30, 2019. See App. A at 21a. The
`Eleventh Circuit denied Hi-Tech and Wheat’s timely
`application for panel rehearing and rehearing en banc
`on April 8, 2020. See App. D at 44a.
`This Court has jurisdiction under 28 U.S.C.
`§1254(1). Supreme Court Rule 13 made this petition
`due on July 7, 2020. This Court’s Order of March 19,
`2020, extended the deadline to file by 60 days, to Sep-
`tember 8, 2020. Hi-Tech and Wheat are filing this pe-
`tition within that timeframe.
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`6
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`7
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`STATUTORY PROVISIONS INVOLVED
` The key text from DSHEA states:
`For the purposes of this chapter . . . The term
`“dietary supplement” – means a product (other
`than tobacco) intended to supplement the diet
`that bears or contains one or more of the follow-
`ing dietary ingredients: (A) a vitamin; (B) a
`mineral; (C) an herb or other botanical; (D) an
`amino acid; (E) a dietary substance for use by
`man to supplement the diet by increasing the
`total dietary intake; or (F) a concentrate, me-
`tabolite, constituent, extract, or combination of
`any ingredient described in clause (A), (B), (C),
`(D), or (E).
`21 U.S.C. §321(ff)(1).
`
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`8
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`STATEMENT OF THE CASE
` This case arises from the FDA’s seizure of millions
`of dollars’ worth of DMAA-containing dietary supple-
`ments from Hi-Tech Pharmaceuticals, Inc. The FDA
`instituted a forfeiture proceeding against the supple-
`ments in the Northern District of Georgia, and Hi-
`Tech and Jared Wheat, the company’s principal owner
`and CEO, intervened as claimants. The FDA’s theory
`as to why these supplements were not marketable
`shifted throughout the litigation. As explained below,
`eventually the FDA prevailed on a ground that was
`distinct from the one the agency first advanced to
`seize these products.
`A. DSHEA’s regulatory structure
` DSHEA is a 1994 law that reflected Congress’s de-
`sire to make dietary supplements more available to
`the public. Before DSHEA, the Food, Drug, and Cos-
`metic Act (“FDCA”) treated dietary supplements like
`drugs, in the sense that manufacturers had to embark
`on a costly and time-consuming process of obtaining
`FDA approval before marketing hem. Among other
`things, the FDCA required that a manufacturer prove
`to the FDA that its dietary supplements were safe for
`public consumption before it could market them. See
`21 U.S.C. §355 (pre-market approval process for
`drugs); 21 C.F.R. §§101.13-14; 101.70.
` DSHEA changed this landscape by distinguishing
`dietary supplements from drugs. DSHEA categorizes
`“dietary supplements” as “foods” rather than “drugs,”
`which allows manufacturers to market them without
`first going through the FDA preapproval process. 21
`U.S.C. §321(ff). The FDA may still remove a dietary
`
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`9
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`
`supplement from the market after a manufacturer
`has begun selling it, but only if the agency meets the
`demanding burden of proving that the supplement or
`one of its ingredients “presents a significant or unrea-
`sonable risk of illness or injury under conditions of use
`recommended or suggested in labeling, or if no condi-
`tions are suggested or recommended in the labeling,
`under ordinary conditions of use.” Id. §342(f)(1)(A)(i)-
`(ii). DSHEA thus withdrew what Congress deemed to
`be the “unreasonable regulatory barriers” that treated
`supplements like drugs. See Dietary Supplement
`Health and Education Act of 1994, Pub. L. No. 103-
`417, §2(13)-(15)(A), 108 Stat. 4325 (1994).
`To this end, DSHEA defines “dietary supplement”
`expansively, to include any “product” that is “intended
`to supplement the diet that bears or contains one or
`more” of a list of “dietary ingredients.” 21 U.S.C.
`§321(ff). Most critically for the purposes of the case,
`this list includes any “constituent” of an “herb or other
`botanical.” Id. Also included are:
` “vitamin[s],”
` “mineral[s],”
` “amino acid[s],”
`
` “dietary substance[s] for use by man to sup-
`plement the diet by increasing the total die-
`tary intake”; and
`constitu-
` “concentrate[s], metabolite[s],
`ent[s], extract[s],” or a “combination” of any
`of the aforementioned ingredients.
`
`
`Id.
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`10
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`B. DMAA’s presence in geranium plants
` After DSHEA made dietary supplements contain-
`ing botanical constituents presumptively marketable,
`evidence emerged that DMAA—a compound that pre-
`viously had been synthesized in laboratories for use in
`nasal decongestants—occurs naturally in geranium
`plants. DMAA has energy-boosting effects much like
`caffeine’s, and its inclusion in dietary supplements
`helps people work out harder and lose weight. Based
`on the evidence showing that DMAA is naturally pre-
`sent in geraniums, manufacturers began including
`this ingredient in their dietary supplements.
`This evidence includes multiple peer-reviewed
`studies showing that DMAA naturally occurs in
`plants of the pelargonium genus, including in the oils
`of those plants. See App. A at 6a–7a; App. C at 34a;
`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/); Zang Ping et al., A Study
`on the Chemical Constituents of Geranium Oil, 25 J.
`GUIZHOU INST. TECH. 82 (1996); J.S. Li et al., Identifi-
`cation and Quantification of Dimethylamylamine in
`Geranium by Liquid Chromatography Tandem Mass
`Spectrometry, 7 ANALYTICAL CHEMISTRY INSIGHTS 47
`(2012); HL Fleming et al., Analysis and Confirmation
`of 1,3-DMAA and 1,4-DMAA in Geranium Plants Us-
`ing High Performance Liquid Chromatography with
`Tandem Mass Spectrometry at ng/g Concentrations, 7
`ANALYTICAL CHEMISTRY INSIGHTS 59 (2012). These
`plants have been consumed for hundreds of years in
`
`
`
`
`
`
`
`11
`
`
`certain parts of the world, often as a dressing on a
`salad or dessert.
`
`
`C. The FDA’s shifting positions on DMAA
` This case arose when the FDA seized Hi-Tech’s
`DMAA-containing supplements, claiming that they
`were not presumptively marketable under DSHEA.
`The FDA then filed an action seeking forfeiture of
`these supplements in the Northern District of Geor-
`gia. But critically and tellingly, the FDA did not prem-
`ise these enforcement actions on the interpretation of
`DSHEA that the District Court and Eleventh Circuit
`majority eventually would adopt: the FDA did not
`claim that DMAA is not a “constituent” of an “herb or
`other botanical” even if it naturally occurs in gerani-
`ums. The FDA instead contended that DMAA was not
`a “constituent” of an “herb or other botanical” on the
`premise that, as a factual matter, the studies dis-
`cussed above were simply wrong—and that DMAA
`does not naturally occur in geraniums at all.
` But as the forfeiture action proceeded, the FDA’s
`theory fell apart, and was even shown to have been
`based on fraudulent research. The FDA had relied on
`one study funded by the United States Anti-Doping
`Agency (“USADA”), a non-governmental organization
`that decides which substances American athletes par-
`ticipating in international competitions are permitted
`to consume. Discovery revealed that USADA had lob-
`bied the FDA to ban DMAA for its own reasons and
`had funded this study to counter the studies finding
`DMAA in geraniums. See Mahmoud A. ElSohly et al.,
`Pelargonium Oil and Methyl Hexaneamine (MHA):
`
`
`
`
`
`
`
`12
`
`
`Analytical Approaches Supporting the Absence of
`MHA in Authenticated Pelargonium Graveolens Plant
`Material and Oil, J. ANALYTICAL TOXICOLOGY 1 (2012).
`Discovery also revealed that the researchers who au-
`thored USADA’s studies had, in fact, found low levels
`of DMAA in geraniums—but had failed to disclose
`that finding in their final report after USADA officials
`told them that a “low level” should not be enough. Doc.
`108-4 at p. 565. The final study instead represented
`that “[n]one of the analyzed oils or the plant material
`(young and mature, fresh and dried leaves and stems)
`showed any detectable level of” DMAA. Doc. 108-4 at
`pp. 572, 585.
` Discovery revealed similar flaws in other studies
`on which the FDA was relying. The FDA had cited a
`second paper by the same researchers, Mahmoud A.
`ElSohly et al., Methylhexanamine is Not Detectable in
`Pelargonium or Geranium Species and Their Essen-
`tial Oils: A Multicentre Investigation, DRUG TESTING
`& ANALYSIS (2014). But in that study also, the re-
`searchers had detected low levels of DMAA in certain
`geraniums. See Doc. 108-5 at pp. 62-67 (email corre-
`spondence from Min Yang of the Shanghai Institute of
`Materia Medica). As with the first study, the authors
`did not report their findings, and instead used a
`higher “detection level” to claim that they had de-
`tected no DMAA in the plants. Still another study had
`similar problems. The original version concluded that
`DMAA naturally occurs in geraniums. See Doc. 108-5
`at pp. 2-11. But the final version said, without any
`acknowledgement of the earlier results, that it had
`
`
`
`
`
`
`
`13
`
`
`not found DMAA in the geraniums “with a limit of de-
`tection of 10 parts per billion.” Ying Zhang et al., 1,3
`Dimethylamylamine (DMAA) in Supplements and Ge-
`ranium Products: Natural or Synthetic?, DRUG TEST-
`ING ANALYSIS (2012).
`
`D. The District Court’s ruling
` After the FDA seized Hi-Tech’s dietary supple-
`ments and instituted its forfeiture action, Hi-Tech and
`Wheat intervened, claiming ownership interests in
`the seized products.1 Following discovery, both sides
`moved for summary judgment. The FDA’s claim was
`that, despite the flaws that had been revealed in the
`studies on which it had relied, the undisputed evi-
`dence showed that DMAA does not naturally occur in
`geraniums and therefore is not a “constituent” of an
`“herb or other botanical” under DSHEA. Hi-Tech, on
`the other hand, argued that the undisputed evidence
`shows that DMAA is naturally in geraniums, and thus
`is a “constituent” of an “herb or other botanical.”
` The District Court had little trouble discarding the
`FDA’s theory. The District Court rejected the FDA’s
`assertion that there was “uncontroverted evidence
`that geraniums cannot make DMAA.” App. C at 34a–
`35a. The District Court instead concluded, based on
`
`1 After the Government seized these dietary supplements but be-
`fore it filed the forfeiture action, Hi-Tech filed an action against
`the FDA and various federal officials in the District Court for the
`District of Columbia, alleging violations of the Administrative
`Procedure Act and the Due Process Clause. See App. A at 2a–3a.
`That court transferred the action to the Northern District of
`Georgia, which consolidated it with the Government’s forfeiture
`action.
`
`
`
`
`
`
`
`14
`
`
`the studies cited by Hi-Tech, that there is “fairly sub-
`stantial evidence that trace amounts of DMAA have
`been found in a species of a geranium plant.” App. C
`at 34a.
`But despite rejecting the FDA’s suggestion that
`the record conclusively resolved the parties’ factual
`dispute, the District Court nonetheless entered sum-
`mary judgment for the Government—based on an in-
`terpretation of DSHEA that the FDA itself had never
`advanced. The District Court held that the evidence
`showing DMAA to be present in geranium plants did
`not establish that it was a dietary ingredient under
`DSHEA. That was so, in the District Court’s estima-
`tion, because “to be a botanical, [a] substance must
`have been extracted from a plant or plant-like organ-
`ism and used, for example, in or as a medicine.” App.
`C at 36a. “While very small amounts of DMAA might
`be present in geraniums,” the District Court found,
`“DMAA in the marketplace has never been extracted
`from geraniums or any other plant.” App. C at 36a–
`37a.2 While recognizing that DSHEA allows dietary-
`supplement manufacturers to use synthesized ingre-
`dients in their products so long as those ingredients
`also occur naturally, the District Court found that, for
`a substance to be a “botanical,” there must be “at least
`
`2 Because the Government had not argued that whether DMAA
`has a history of being derived from geraniums was relevant, the
`parties had conducted no discovery on the issue. See App. A at
`3a. Hi-Tech and Wheat argued in their motion for reconsidera-
`tion that the District Court should allow them to conduct discov-
`ery on this issue. See App. A at 3a. The District Court denied that
`motion, and the Eleventh Circuit affirmed. See App. B at 29a;
`App. A at 17a–19a.
`
`
`
`
`
`
`
`15
`
`
`some history of the substance in question having been
`extracted in usable quantities” from a plant. App. C at
`37a. Under that standard—and without considering
`whether DMAA, if not a botanical, is at least a “con-
`stituent” of a botanical—the District Court concluded
`that “DMAA is not a botanical and thus not a dietary
`ingredient.” App. C at 37a.3
`Hi-Tech and Wheat filed a motion to reconsider,
`observing that the District Court had not addressed
`whether DMAA is, at the very least, a “constituent” of
`a botanical. The District Court denied the motion, ex-
`plaining that its analysis applied “by extension” to the
`question whether DMAA is a botanical “constituent.”
`App. B at 28a.
`
`E. The Eleventh Circuit’s decision
` Hi-Tech and Wheat appealed, and a divided Elev-
`enth Circuit affirmed. See App. A at 2a–26a.
`The majority op
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