United States v. An Article of Food Consisting of 126 Cases, more or less, Each Containing 12 Three-Pound Jars, Labeled: (Case & Jar) "Pure Raw Honey Packed for J.G. Samples

550 F. Supp. 15, 1982 U.S. Dist. LEXIS 15667
CourtDistrict Court, W.D. Oklahoma
DecidedJune 1, 1982
DocketNo. CIV-81-206-D
StatusPublished

This text of 550 F. Supp. 15 (United States v. An Article of Food Consisting of 126 Cases, more or less, Each Containing 12 Three-Pound Jars, Labeled: (Case & Jar) "Pure Raw Honey Packed for J.G. Samples) is published on Counsel Stack Legal Research, covering District Court, W.D. Oklahoma primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. An Article of Food Consisting of 126 Cases, more or less, Each Containing 12 Three-Pound Jars, Labeled: (Case & Jar) "Pure Raw Honey Packed for J.G. Samples, 550 F. Supp. 15, 1982 U.S. Dist. LEXIS 15667 (W.D. Okla. 1982).

Opinion

ORDER

DAUGHERTY, District Judge.

This matter comes before the Court on the Motion of J.G. Samples, the intervening Claimant, for approval of labels with which he proposes to bring the condemned article of food into compliance with the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (the “Act”). The Motion is supported with a Brief, the Plaintiff has responded with a Brief, and oral arguments have been heard. The administrative record has been filed herein, and the parties have agreed that it is complete.

A decree was previously entered herein, by consent of the parties, condemning the libeled article of food for reasons of adulteration and misbranding. In the decree, the Court permitted the Claimant to take custody of the condemned article, subject to certain conditions, “for the purpose of attempting to bring said article into compliance with the Federal Food, Drug, and Cosmetic Act” under the supervision of the Food and Drug Administration (“FDA”) of the Department of Health and Human Services. This disposition of the condemned article was made pursuant to 21 U.S.C. § 334(d)(1), which provides the Court with authority to direct that the article be delivered to the owner to be destroyed or brought into compliance “under the supervision of an officer or employee duly designated by the Secretary [of the Department of Health and Human Services].” The Court of Appeals for the Tenth Circuit has said:

“The trial court has a wide discretion in determining whether an article condemned under § 352 may be delivered to an intervening claimant under § 334(d) [17]*17to be brought within compliance with the Drug Laws under the supervision of the Secretary or his delegate, [citations omitted] But, the question whether an article condemned for its false and misleading labeling has been brought within compliance of the Act is a different matter altogether. As to that, the supervisory powers committed to the Secretary undoubtedly carry broad authority to determine whether and in what manner the labeling may be brought within compliance with the Act. The judicial function is concerned with the end product of the labeling process. While the final decision lies with the courts, great weight must be given to the administrative decision.” United States v. Allan Drug Co.r 357 F.2d 713, at 719 (10th Cir.1966).

Hence, if the Court exercises its discretion to permit an intervening claimant to attempt to bring the condemned article into compliance with the Act, it must be done under administrative supervision, and the initial determination of the legality of the new labeling is for the administrative body. United States v. An Article of Device ... Diapulse, 650 F.2d 908 (7th Cir.1981).

As to the form of the review, while the Court must give great weight to the administrative decision, the determination of whether the Claimant has satisfied the conditions of the Court’s decree rests finally with the Court, and the Court should consider evidence offered by the parties even though it may go beyond the administrative record. See Buticaps, Inc. v. United States, 102 U.S.App.D.C. 253, 252 F.2d 634 (1958), in which the Court, without mentioning any post-decree administrative determination as to the proposed relabeling, held that where the decree of the Court gave the claimant an opportunity to bring the label into compliance, it was error and a denial of due process to deny a motion of the claimant to approve the use of the name “Buticaps” without an evidentiary hearing to determine whether the name was misleading. However, such evidence should not substantially change the nature of the proposed relabeling, lest the Court permit the Claimant to short circuit or avoid the FDA supervision required by statute. In the instant case, the parties have filed a Stipulation as to all material facts not apparent from the record, and the Court finds that the Stipulation does not change the nature of the proposed relabeling. As the parties were given an opportunity at the hearing on the instant Motion to present evidence beyond the administrative record and the Stipulation and declined so to do, the Court may decide the Motion on the basis of the record and the Stipulation.

The test the Court must apply in reviewing the relabeling decision of the FDA is whether the FDA’s rejection of the relabeling proposal was arbitrary and capricious or an abuse of discretion. United States v. 1,688 Cases of Adulterated Alcoholic Beverage, 624 F.2d 900 (9th Cir.1980); United States v. Various Cases of Adulterated Alcoholic Beverages, 421 F.Supp. 1 (D. Alaska 1976). Drawing on Federal Trade Commission cases, the Court of Appeals for this Circuit, in United States v. Allan Drug Corp., supra, similarly defined the test as whether the administrative decision “is warranted in the record and supported in law,” 357 F.2d at 718-719.

Whether the proposed label would “misbrand” the article depends on the meaning of the relevant regulation. The Act authorizes the promulgation of “standards of identity” for food, and such “standards of identity” are required to designate the optional ingredients, if such are permitted, which shall be named on the label. 21 U.S.C. § 341 provides, in pertinent part:

Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, and/or reasonable standards of fill of container: ... In prescribing a definition and standard of identity for any food or class of food in which optional ingredients are permitted, the Secretary shall, for the purpose of promoting honesty and [18]*18fair dealing in the interest of consumers, designate the optional ingredients which shall be named on the label.

The condemned article of food herein was originally labeled “Pure Raw Honey” but, the parties agree, actually falls within the definition of “Table Sirup” as defined by the standard of identity which has been promulgated for that product, 21 C.F.R. § 168.180. This regulation, as required by the statute, specifies that the optional ingredients that may be used in the standardized food called “table sirup” include, inter alia, emulsifiers, stabilizers, flavorings, col- or. additives, chemical preservatives, and agents of various kinds. As to labeling, Section 168.180 states:

(d)(1) Each of the optional ingredients used shall be declared on the label as required by the applicable sections of Part 101 of this chapter.

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550 F. Supp. 15, 1982 U.S. Dist. LEXIS 15667, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-an-article-of-food-consisting-of-126-cases-more-or-less-okwd-1982.