U.S. v. Ten Cartons, More or Less, of an Article Ener-B Vitamin B-12, ENER-B

CourtU.S. Court of Appeals — Second Circuit
Writing for the CourtPER CURIAM
Citation72 F.3d 285
PartiesUNITED STATES of America, Plaintiff-Appellee, v. TEN CARTONS, MORE OR LESS, OF AN ARTICLE ... * * *VITAMIN, etc., et al., Defendants. UNITED STATES of America, Plaintiff-Appellee, v. NATURE'S BOUNTY, INC., Defendant-Appellant. ockets 95-6051, 95-6063.
Docket Number251,B-12,ENER-B,Nos. 250,D
Decision Date19 December 1995

Page 285

72 F.3d 285
UNITED STATES of America, Plaintiff-Appellee,
v.
TEN CARTONS, MORE OR LESS, OF AN ARTICLE ... * * *ENER-B
VITAMIN B-12, etc., et al., Defendants.
UNITED STATES of America, Plaintiff-Appellee,
v.
NATURE'S BOUNTY, INC., Defendant-Appellant.
Nos. 250, 251, Dockets 95-6051, 95-6063.
United States Court of Appeals,
Second Circuit.
Argued Oct. 18, 1995.
Decided Dec. 19, 1995.

Page 286

Charles S. Kleinberg, Assistant United States Attorney for the Eastern District of New York, Brooklyn, New York (Zachary W. Carter, United States Attorney, Igou Allbray, Deborah B. Zwany, Assistant United States Attorneys, Brooklyn, New York, Denise Zavagno, Matthew Eckle, Food and Drug Administration, Washington, D.C., of counsel), for Plaintiff-Appellee.

Milton A. Bass, New York City (Robert Ullman, Jacob Laufer, James N. Czaban, Bass & Ullman, P.C., New York City, of counsel), for Defendant-Appellant.

Before: MESKILL, MAHONEY, and WALKER, Circuit Judges.

PER CURIAM:

Defendant-appellant Nature's Bounty, Inc. ("Nature's Bounty") appeals from a judgment entered April 14, 1995 in the United States District Court for the Eastern District of New York, Arthur D. Spatt, Judge, that permanently enjoined Nature's Bounty from introducing into interstate commerce Ener-B Nasal Gel ("Ener-B"), a vitamin B-12 supplement in gel form designed to be applied to the inside of the nose and absorbed into the bloodstream through the nasal mucosal membranes, or any other nasally administered nutrient unless and until authorized by a new drug application that has been reviewed and approved by the Food and Drug Administration (the "FDA") pursuant to 21 U.S.C. Sec. 355. Initially by order of the district court and subsequently by stipulation of the parties, enforcement of the injunction was stayed pending the resolution of this appeal.

The district court ruled that Ener-B is a drug within the meaning of Sec. 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the "FDCA"), 21 U.S.C. Sec. 321(g)(1)(C), which classifies as drugs "articles (other than food) intended to affect the structure or any function of the body of man." 1 See United States v. Ten Cartons, Ener-B Nasal Gel, 888 F.Supp. 381 (E.D.N.Y.1995). Because Nature's Bounty conceded that Ener-B is "intended to affect the structure or any function of the body," the key issue below regarding Sec. 321(g)(1)(c) was whether Ener-B's unique method of intake rendered it "other than food" within the meaning of that subsection. See id. at 390-92. The district court also determined that Ener-B is not a "dietary supplement" within the meaning of 21 U.S.C. Sec. 321(ff), 2 a provision that was added

Page 287

to the FDCA by Sec. 3 of the Dietary Supplement Health and Education Act of 1994, Pub.L. No. 103-417, 1994 U.S.C.C.A.N. (108 Stat.) 4325, 4327 (the "DSHEA"). See 888 F.Supp. at 392-95.

Nature's Bounty contends on appeal that Ener-B is a "dietary supplement" within the meaning of Sec. 321(ff), and that because it is a dietary supplement, Ener-B cannot be a Sec. 321(g)(1)(C) drug. The district court...

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15 practice notes
  • Food for human consumption: Food labeling— Dietary supplements; effect on structure or function of body; types of statements, definition,
    • United States
    • Federal Register January 06, 2000
    • 6 January 2000
    ...of the act. Finally, FDA does not agree that, under United States v. Ten Cartons, More or Less, of an Article * * * Ener-B Vitamin B-12, 72 F.3d 285 (2d Cir. 1995), dietary supplements making weight loss claims must necessarily be regulated as drugs. The court in Ener-B held that a dietary ......
  • Coyne Beahm, Inc. v. U.S. Food & Drug Admin., No. 2:95CV00591.
    • United States
    • United States District Courts. 4th Circuit. Middle District of North Carolina
    • 25 April 1997
    ...it, but may look at all relevant sources."), aff'd, 344 F.2d 288 (6th Cir.1965); United States v. Ten Cartons Ener-B Vitamin B-12, 72 F.3d 285, 287 (2d Cir.1995) (An article can be a drug under 21 U.S.C. § 321(g)(1)(C) for reasons other than claims made in the label or labeling, such as "me......
  • Nve, Inc. v. Department of Health and Human Serv., No. 04-4481.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (3rd Circuit)
    • 7 February 2006
    ...previous drafts of DSHEA are indicative of congressional intent, see United States v. Ten Cartons, More or Less, of an Article ..., 72 F.3d 285, 286 (2d Cir.1995) (relying on previous version of DSHEA to interpret the enacted 5. The Senate draft of the DSHEA read, in pertinent part: (f) [A ......
  • Lewis v. Grinker, No. CV-79-1740-CPS.
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • 19 January 2000
    ...version of the Act, S.643, in favor of a more relaxed standard of House version of the statute, H.R.2816); United States v. Ten Cartons, 72 F.3d 285, 287 (2d Cir.1995) (giving persuasive weight to Congress' rejection of an earlier version of the Dietary Supplement and Health Education Act (......
  • Request a trial to view additional results
12 cases
  • Coyne Beahm, Inc. v. U.S. Food & Drug Admin., No. 2:95CV00591.
    • United States
    • United States District Courts. 4th Circuit. Middle District of North Carolina
    • 25 April 1997
    ...it, but may look at all relevant sources."), aff'd, 344 F.2d 288 (6th Cir.1965); United States v. Ten Cartons Ener-B Vitamin B-12, 72 F.3d 285, 287 (2d Cir.1995) (An article can be a drug under 21 U.S.C. § 321(g)(1)(C) for reasons other than claims made in the label or labeling, such as "me......
  • Nve, Inc. v. Department of Health and Human Serv., No. 04-4481.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (3rd Circuit)
    • 7 February 2006
    ...previous drafts of DSHEA are indicative of congressional intent, see United States v. Ten Cartons, More or Less, of an Article ..., 72 F.3d 285, 286 (2d Cir.1995) (relying on previous version of DSHEA to interpret the enacted 5. The Senate draft of the DSHEA read, in pertinent part: (f) [A ......
  • Lewis v. Grinker, No. CV-79-1740-CPS.
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • 19 January 2000
    ...version of the Act, S.643, in favor of a more relaxed standard of House version of the statute, H.R.2816); United States v. Ten Cartons, 72 F.3d 285, 287 (2d Cir.1995) (giving persuasive weight to Congress' rejection of an earlier version of the Dietary Supplement and Health Education Act (......
  • USA v. Univ. Mgmt. Serv, No. 98-3310
    • United States
    • United States Courts of Appeals. United States Court of Appeals (6th Circuit)
    • 10 August 1999
    ...(recalls); United States v. Ten Cartons, Ener-B Nasal el, 888 F.Supp. 381 Page 762 (E.D.N.Y. 1995) (disgorgement), aff'd on other grounds, 72 F.3d 285 (2d Cir. 1995). Portions of the legislative history relating to the FDCA indicates that Congress was concerned about the harshness and serio......
  • Request a trial to view additional results

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