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July 26, 1974


The opinion of the court was delivered by: Decker, District Judge.


This is an action under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq., in which the government seeks to enjoin defendants' alleged violations of sections 301(a) and 301(k) of that Act. 21 U.S.C. § 331(a), (k). Jurisdiction of this court is founded upon 21 U.S.C. § 332(a).

This suit was instituted on May 30, 1974, by the filing of a complaint and a motion for a temporary restraining order. The complaint alleges that defendants, a corporation and two of its officers, are engaged in causing the manufacture of an article of cosmetic, within the meaning of 21 U.S.C. § 321(i), designated by the name "Long Nails". Said cosmetic is claimed to be adulterated within the definition of 21 U.S.C. § 361(a) in that the article contains a "poisonous or deleterious substance" — methyl methacrylate monomer — "which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual." Id.

The government maintains that defendants are violating 21 U.S.C. § 331(a) by introducing and delivering, or causing to be introduced and delivered, into interstate commerce an adulterated article of commerce. It is further averred that defendants are violating 21 U.S.C. § 331(k) by causing said cosmetic to be manufactured, packed and labeled, while it is held for shipment in interstate commerce, which acts result in the adulteration of the product. After extended hearings, this court found that a preliminary showing had been made that defendants had violated 21 U.S.C. § 331(a) and § 331(k) and issued a preliminary injunction prohibiting defendants from, inter alia, introducing, or delivering for introduction, into interstate commerce any of said cosmetic which contains methyl methacrylate monomer, and from manufacturing, packing and labeling said article from components that have been shipped in interstate commerce and which results in the article containing methyl methacrylate monomer.

The Government's prayer for relief also requested that the court order defendants to notify all persons, down to the retail level, to whom any of the cosmetic had been distributed, that the product contained a poisonous or deleterious substance and to "direct all such persons to return the article to the defendants." All parties, and the court, have viewed that paragraph as a demand for a judicially-ordered "recall" of those packages of Long Nails which may still be sitting on store or warehouse shelves. Defendants strenuously object to this demand, arguing that the court is without authority under the Federal Food, Drug and Cosmetic Act (hereinafter cited as "the Act" or "the FDCA") to order a recall, and that even if such authority exists, the court should decline to enter such an order as a matter of discretion. In light of the apparent novelty and the undoubted seriousness of this question, the court ordered briefs on the point and took the issue under advisement. After reviewing the memoranda of both parties, the court ruled orally from the bench that it had concluded that it possessed no power in the circumstances of this case to order a recall. This Memorandum Opinion is intended to set forth the reasons behind that conclusion.

The Government brought this suit for injunction pursuant to section 302(a) of the Act, which provides, in relevant part, that:

  "The district courts of the United States . . .
  shall have jurisdiction, for cause shown . . . to
  restrain violations of section 331 of this
  Title. . . ." 21 U.S.C. § 332(a).*fn1

A careful review of the FDCA in its entirety reveals that this is the sole authorization for equitable relief.*fn2 And it is clear that nowhere in section 302(a) is recall specifically mentioned. See Clevenger, Recalls, 27 Food, Drug Cosm.L.J. 332 (1972); Cody, Food Recalls, 27 Food, Drug Cosm.L.J. 336 (1972); Lambert, Voluntary Recalls or Delegated Seizures: The Legal Considerations, 27 Food, Drug Cosm.L.J. 668 (1972). The section appears to contemplate only negative injunctions prohibiting statutory violations, rather than any sort of mandatory or affirmative relief. See Note, Restitution in Food and Drug Enforcement, 4 Stan.L.Rev. 519, 521 (1952). Indeed, one close student of the Act has concluded that "[a]n injunction [under the FDCA] should forbid only the acts which are prohibited by the statute." Toulmin, The Law of Foods, Drugs and Cosmetics § 7.4, at 100 (1963). Thus, no explicit statutory authorization for either administrative or judicial recalls exists. H.R.Rep.No.585, 92d Cong., 1st Sess. 3 (1971).

The legislative history of the Act apparently contains no reference to the recall remedy. Indeed, the legislative background is of relatively minimal assistance in determining congressional intent with respect to the injunctive provision at all; section 302 caused little discussion. See H.R.Rep.No.2716, 75th Cong., 3d Sess. 22 (1938); H.R. Rep.No.2139, 75th Cong., 3d Sess. 3-4 (1938); S.Rep.No.361, 74th Cong., 1st Sess. 30 (1935); Note, Restitution in Food and Drug Enforcement, 4 Stan.L. Rev. 519, 521 and n. 17 (1952).

Initially, it is noteworthy that the Federal Food and Drugs Act of 1906*fn3 contained no injunctive provision. The basic judicial and administrative procedures for enforcement of the 1906 Act's prohibitions were four-fold: (1) criminal proceedings, (2) libel for condemnation proceedings, and (3) administrative exclusion of imports, and (4) administrative inspection proceedings concerning seafoods. See Lee, The Enforcement Provisions of the Food, Drug and Cosmetic Act, 6 Law & Contemp.Prob. 70 (1939). Thus, there existed no injunctive precedent which Congress could be deemed to have approved in section 302(a) or which could have guided Congress in shaping that provision.

Secondly, the scant legislative history which does exist suggests, if anything, that Congress was concerned with the harshness of the remedies upon manufacturers. The objectives sought by Congress in providing for the new injunctive procedure, and congressional regard for injunctions in the enforcement matrix, are perhaps best indicated by the following excerpt from the report of the House of Representatives:

  "This procedure will be particularly advantageous
  in border-line cases that cannot be settled
  without litigation. In many such cases it is
  unfair to the manufacturer to subject him to
  criminal trial and likewise unfair to the public
  to have the issue determined under the
  restrictions necessarily prevailing in criminal
  procedure. This remedy should reduce litigation.
  In some cases it should avoid the hardship

  and expense to litigants in seizure cases. In
  many instances seizure is a harsh remedy and
  should be discouraged or confined to those cases
  where the public protection requires such action.
  In many cases, it is believed . . . injunctions
  can be used with equal effectiveness and with
  less hardship. A seizure case finally decided in
  favor of a defendant leaves him without recourse
  for his losses, including court costs, storage,
  and other charges." Lee, Enforcement Provisions,
  supra at 85, quoting, H.R. Rep.No.2139, 75th Cong.,
  3d Sess. 3-4 (1938).

This passage strongly suggests that the House, at least, considered seizure to be the most severe remedy and that injunctive proceedings were viewed as a means to alleviate the hardships seizures might cause to manufacturers. Given this orientation, and the potential difficulties concomitant to a recall, see generally Thomas, Production Records: Tracing and Recording of Ingredients, 27 Food, Drug Cosm.L.J. 680 (1972); Livingston, The Removal and Disposal of Suspect Product, 27 Food, Drug Cosm.L.J. 702 (1972); Khan & Healton, Recall of Food Products: Emergency Standby Procedures at the Home Office, 27 Food, Drug Cosm.L.J. 702 (1972), it is difficult to conclude that Congress intended section 302(a) to authorize judicial recalls.

Despite this congressional silence, recalls have played an increasingly significant role in the FDA's enforcement of the Act. Approximately 18 years ago, the agency initiated procedures for the voluntary recall of violative products, as an alternative to seizures, prosecution, and injunctive actions. H.R.Rep.No.585, 92d Cong., 1st Sess. 3 (1971). In March, 1971, a subcommittee of the House of Representatives Committee on Government Operations held a hearing on these recall practices. Hearing on Recall Procedures of the Food and Drug Administration Before a Subcomm. of the House Comm. on Gov't Operations, 92d Cong., 1st Sess. (1971). Questioning of senior FDA officials made clear that neither the members of the subcommittee nor the FDA considered the Act to ...

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