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HETEROCHEMICAL CORP. v. FDA

September 23, 1986

HETEROCHEMICAL CORPORATION, et al., Plaintiffs,
v.
FOOD AND DRUG ADMINISTRATION, et al., Defendants



The opinion of the court was delivered by: GLASSER

MEMORANDUM AND ORDER

GLASSER, United States District Judge

 Plaintiffs Heterochemical Corportion and William Galler ("Heterochemical") have brought this action against the Food and Drug Administration ("FDA") seeking to require the FDA to enforce the Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq. ("FDCA" or "the Act") with respect to certain products which it contends are being unlawfully marketed by its competitors. The action is now before the Court on the FDA's motion to dismiss on the ground that its decision not to take certain enforcement steps in this case is not subject to review by this Court. For the reasons stated herein, the motion will be denied.

 I. Background

 A. Statutory Scheme

 Before turning to the facts of this case, it is necessary to survey briefly the relevant provisions of the FDCA. The FDCA prohibits "[t]he introduction or delivery into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded." 21 U.S.C. § 331(a). A food is deemed to be adulterated "if it is, or it bears or contains, any food additive which is unsafe." Id. § 342. The Act, in turn, provides that "[a] food additive shall, with respect to any particular use or intended use of such additive, be deemed unsafe" unless such use is in conformity with a food additive regulation. Id. § 348(a). Finally, "food additive" is defined to include all animal feed ingredients except those covered by a "prior sanction" issued before September 6, 1958 and those generally recognized as safe ("GRAS") either based on common use in food prior to January 1, 1958 or based on data developed through scientific procedures. Id. § 321(5). Working backwards, these statutes provide that no animal feed ingredient may be introduced into interstate commerce unless it is GRAS or prior-sanctioned (and thus is not a food additive) or it is used in conformity with a food additive regulation.

 B. Factual Background

 Heterochemical is a manufacturer of swine and poultry feed ingredients known as Vitamin K Active Substances ("VKAS"). Heterochemical markets two VKAS products, menadione dimethyl primidinol bisulfite ("MPB"), marketed under the name Hetrazeen, and menadione sodium bisulfite complex ("MSBC"), sold under the name Hetrogen K. The use of MPB in swine, chicken, and turkey rations at specified levels is authorized by a food additive regulation, 21 C.F.R. § 573.620. MSBC is prior sanctioned for use in poultry feeds at levels of 2 to 4 grams per ton.

 In 1974, Heterochemical petitioned the FDA to enforce the FDCA against three VKAS products sold by its competitors. These products are menadione sodium bisulfite ("MSB"), MSBC in a chemically distinct form from that sold by Heterochemnical and thus not covered by the prior sanction, and MSBC marketed for use other than in poultry feeds and not authorized by a food additive regulation. In August 1976, the FDA published notice of Heterochemical's petition and sought public comment. Almost seven years later, in April 1983, the FDA denied Heterochemical's petition. Heterochemical alleges, and we take this allegation to be true for purpose of this motion, that the FDA made "every predicate finding necessary to a determination that the marketing of the challenged VKAS products is in fact unlawful." Heterochemical's Brief at 1. In other words, the FDA found that the animal feed ingredients sold by Heterochemical's competitors were neither GRAS or prior-sanctioned, nor were they covered by a food additive regulation. Nevertheless, although these findings indicate that these products could not lawfully be introduced into interstate commerce, the FDA decided it would take no further action, concluding that "VKAS have been added to animal food for more than 30 years, without apparent animal or human safety problems." 48 Fed. Reg. 16750.

 C. Heckler v. Chaney

 Heterochemical, dissatisfied with the FDA's disposition of its petition, brought this action to compel the FDA to do more. The FDA moves to dismiss this action on the ground that its decision to enforce or not to enforce is immune from judicial review. This argument is predicated entirely on Heckler v. Chaney, 470 U.S. 821, 105 S. Ct. 1649, 84 L. Ed. 2d 714 (1985), decided by the United States Supreme Court two terms ago.

 In Chaney, a group of prison inmates sentenced to die by lethal injection petitioned the FDA arguing that the drugs that were to be administered to them had not been approved as "safe and effective" for human execution. They argued that the distribution of the drugs in interstate commerce for other than their intended and approved purpose constituted a violation of the FDCA. The FDA refused to take action, but was ordered to do so by the Court of Appeals for the District of Columbia Circuit. Chaney v. Heckler, 231 U.S. App. D.C. 136, 718 F.2d 1174 (D.C. Cir. 1983). The Supreme Court reversed, endeavoring to determine "the extent to which determinations by the FDA not to exercise its enforcement authority over the use of drugs in interstate commerce may be judicially reviewed." 105 S. Ct. at 1654 (emphasis in original).

 The Court began with a discussion of § 701(a)(2) of the Administrative Procedure Act, which bars review of administrative agency action when that action "is committed to agency discretion by law." The Court interpreted this section to mean that "even where Congress has not affirmatively precluded review, review is not to be had if the statute is drawn so that a court would have no meaningful standard against which to judge the agency's exercise of discretion." Id. at 1655. Applying this standard, the Court established a presumption that "[r]efusals to take enforcement steps," id. at 1655-56 are not reviewable. The Court stressed the unsuitability of review of such decisions, pointing out, inter alia, that "[t]he agency is far better equipped than the courts to deal with the many variables involved in the proper ordering of its priorities." Id. at 1656.

 Having established this presumption, the Court noted that "the presumption may be rebutted where the substantive statute has provided guidelines for the agency to follow in exercising its enforcement powers." Id. As an example of a case where that presumption was rebutted, the Court cited the case of Dunlop v. Bachowski, 421 U.S. 560, 44 L. Ed. 2d 377, 95 S. Ct. 1851 (1975). In that labor case, the statute provided that, upon filing of a complaint by a union member, "[t]he Secretary shall investigate such complaint and, if he finds probable cause to believe that a violation . . . has occurred . . . he shall . . . bring a civil action. . . ." ...


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