United States v. 21 Approximately 180 Kg. Bulk Metal Drums

761 F. Supp. 180, 1991 U.S. Dist. LEXIS 5125, 1991 WL 57890
CourtDistrict Court, D. Maine
DecidedApril 9, 1991
Docket88-0101-P
StatusPublished
Cited by4 cases

This text of 761 F. Supp. 180 (United States v. 21 Approximately 180 Kg. Bulk Metal Drums) is published on Counsel Stack Legal Research, covering District Court, D. Maine primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. 21 Approximately 180 Kg. Bulk Metal Drums, 761 F. Supp. 180, 1991 U.S. Dist. LEXIS 5125, 1991 WL 57890 (D. Me. 1991).

Opinion

761 F.Supp. 180 (1991)

UNITED STATES of America, Plaintiff,
v.
21 APPROXIMATELY 180 KG. BULK METAL DRUMS, MORE OR LESS, OF AN ARTICLE OF FOOD AND DRUG...., Defendant,
Efamol, Inc., Claimant.

No. 88-0101-P.

United States District Court, D. Maine.

April 9, 1991.

*181 David R. Collins, Asst. U.S. Atty., Portland, Me., Mary K. Pendergast, Associate Chief Counsel for Enforcement, Office of the Gen. Counsel, Dept. of Health & Human Services, Food and Drug Admin., Rockville, Md., for U.S.

John A. Graustein, Portland, Me., Robert A. Dormer, A. Wes Siegner, Jr., James R. Phelps, Washington, D.C., for Efamol, Inc.

MEMORANDUM OF DECISION AND ORDER

GENE CARTER, Chief Judge.

Plaintiff United States of America seized Defendant 21 Metal Drums pursuant to an order of this Court issued March 31, 1988. See Order for Arrest of Property (Docket No. 2). The drums contain articles of food and drug consisting in whole or part of either Evening Primrose Oil or Black Currant Oil (a/k/a Starflower Oil). Plaintiff alleges that these articles are misbranded drugs and/or adulterated foods containing unsafe food additives held for sale after shipment in interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (hereinafter Act). 21 U.S.C. § 301 et seq.[1] Claimant Efamol, Inc. denies that the articles are "drugs," as that term is defined in 21 U.S.C. section 321(g), or "food additives," under 21 U.S.C. section 321(s), and further denies that the articles were misbranded under 21 U.S.C. section 352(f)(1).[2] Plaintiff now moves for summary judgment on its Complaint[3] seeking condemnation of the seized articles and any other appropriate relief.

I. SUMMARY JUDGMENT

A motion for summary judgment must be granted if:

the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show *182 that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.

Fed.R.Civ.P. 56(c). The moving party's initial burden is to demonstrate to the Court that there is no genuine issue of material fact. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48, 106 S.Ct. 2505, 2509-10, 91 L.Ed.2d 202 (1986). The Court of Appeals for the First Circuit has explained the summary judgment process as follows:

[T]he movant must adumbrate `an absence of evidence to support the nonmoving party's case.' Celotex Corp. v. Catrett, 477 U.S. 317, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). When that is accomplished, the burden shifts to the opponent to establish the existence of a fact issue which is both `material,' in that it might affect the outcome of the litigation, Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 2510, 91 L.Ed.2d 202 (1986); Hahn v. Sargent, 523 F.2d 461, 464 (1st Cir.1975), cert. denied, 425 U.S. 904, 96 S.Ct. 1495, 47 L.Ed.2d 754 (1976), and `genuine,' in that a reasonable jury could, on the basis of the proffered proof, return a verdict for the opponent. Anderson, 477 U.S. at 248, 106 S.Ct. at 2510; Oliver v. Digital Equipment Corp., 846 F.2d 103, 105 (1st Cir.1988). It is settled that the nonmovant may not rest upon mere allegations, but must adduce specific, provable facts demonstrating that there is a triable issue. `The evidence illustrating the factual controversy cannot be conjectural or problematic; it must have substance in the sense that it limns differing versions of the truth which a factfinder must resolve at an ensuing trial.' Mack v. Great Atlantic and Pacific Tea Co., 871 F.2d 179, 181 (1st Cir.1989). As the Supreme Court has said:
[T]here is no issue for trial unless there is sufficient evidence favoring the nonmoving party for a jury to return a verdict for that party. If the evidence is merely colorable, or is not significantly probative, summary judgment may be granted.
Anderson, 477 U.S. at 249-50, 106 S.Ct. at 2510-11.

Brennan v. Hendrigan, 888 F.2d 189, 191-92 (1st Cir.1989) (quoted in MCI Telecommunications Corp. v. Franklin-Centennial Corp., 128 F.R.D. 158, 158-59 (D.Me. 1989)).

Plaintiff and Claimant do not dispute, in large part, the material facts of this case. The articles seized by Plaintiff include the following: (1) bulk Evening Primrose Oil (hereinafter EPO) and Vitamin E; (2) capsules containing EPO and Vitamin E; (3) "Efacom" capsules containing EPO, fish oil, and vitamin E; (4) "Efamol PMS" capsules containing black currant oil (hereinafter BCO), fish oil, various vitamins and minerals; and (5) "Efamax" capsules containing BCO, fish oil, various vitamins and minerals, and other ingredients. These products were all in the process of being shipped for further processing (in the case of the bulk EPO), distribution, and sale.

Plaintiff has adduced uncontradicted evidence that Claimant has distributed promotional materials claiming that EPO, alone and in combination with other ingredients, helps to prevent, treat, or cure a broad array of maladies ranging from atopic dermatitis to cancer, obesity, and schizophrenia. Similarly broad claims have been made regarding the Efacom and Efamax capsules. Plaintiff's evidence also establishes that Claimant has represented that Efamol PMS prevents, treats, or cures premenstrual syndrome and its associated symptoms. In addition, Claimant admitted in response to interrogatories that each of these items is intended for use as a nutritional or dietary supplement.

II. EPO AND BCO AS UNSAFE FOOD ADDITIVES

A.

The Act defines a "food additive" to be any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, *183

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