Appeal From the United States District Court for the District of New Jersey.
Before: Adams and Hunter, Circuit Judges, and Schwartz, District Judge*fn*
Presently before the Court is an appeal from a Preliminary Injunction secured by the government pursuant to the Federal Food, Drug and Cosmetic Act ("the Act"), 28 U.S.C. § 332(a), and from an Order for Civil Contempt arising out of alleged violations of a Temporary Restraining Order and the Preliminary Injunction. The appellants are Spectro Foods Corporation ("Spectro") and Metamail Food Corporation ("Metamail"), both New Jersey corporations, Ernst O. Moenckmeier, president, and Jeanene Moenckmeier, secretary-treasurer of the two corporations. They manufacture and distribute a product known as "Bitter Food Tablets" which they allegedly market for use in the treatment of cancer. The Complaint alleged that Bitter Food Tablets contain amygdalin*fn1 which is an "unsafe" "food additive", that the tablets themselves are a "food", a "drug" and a "new drug", and consequently that the defendants were in violation of section 331(a), (d) and (k) by virtue of their manufacture, distribution and holding for sale of an "adulterated food", a "misbranded drug" and an unapproved "new drug".
At the time the complaint was filed on January 19, 1975, the district judge entered a Temporary restraining Order ("TRO") which restrained the manufacture and distribution of Bitter Food Tablets. At the government's urging that the public safety was jeopardized by the current availability of these tablets, the court further ordered Spectro to recall all previously distributed tablets by January 23. The next procedural development was an ex parte hearing held on Saturday, January 24.*fn2 The result of the January 24 hearing was the issuance of an order to show cause why defendants should not be held in contempt for failure to comply with the recall order.
A hearing was held on January 28 to determine whether a preliminary injunction should issue and whether defendants should be held in contempt for violation of the TRO. At that time, a compliance schedule was set up and the contempt matter held in abeyance. The district judge also made findings of fact and conclusions of law and on January 29, he issued a preliminary injunction, the scope of which is contested in this appeal. The Preliminary InJunction not only incorporated the restraints on manufacture and distribution and the recall order of the TRO, but also restrained the distribution of any food additive or drug in violation of the Federal Food, Drug and Cosmetic Act. The court added further provisions which, in effect, ordered the F.D.A. to supervise and control the conduct of defendants' business.
On February 9, the government, having concluded that the defendants had defaulted on the agreed upon compliance schedule, moved for a second order to show cause why a contempt order should not issue. At a hearing on February 17, the corporate defendants, Spectro and Metamail, were found in contempt for non-compliance with the recall order contained in the TRO and the Preliminary InJunction, and on the following day the district judge issued an "Order for Civil Contempt."
The defendants responded on February 20 by filing notice of this appeal from the TRO, the Preliminary Injunction and the Order for Civil Contempt. On February 27, a judge of this court denied a stay of these three orders.
I. Jurisdiction of the Reviewing Court
The Preliminary Injunction is a reviewable interlocutory order under the jurisdiction conferred by 28 U.S.C. § 1292(a)(1). Although an order of civil contempt is not ordinarily appealable,*fn3 one who is a party may appeal from a civil contempt order in connection with some other appealable order, including a preliminary injunction.*fn4 Consequently, the Court has jurisdiction over the appeal from the Order for Civil Contempt.*fn5
A TRO is not an injunction and consequently is not an appealable order.*fn6 Further, any purported notice of appeal from the TRO was not timely filed*fn7 and the TRO had, by its terms, expired prior to the appeal. The Court therefore need not consider whether the provisions of the TRO which did more than merely temporarily restrain de fendants converted it into a form of an interlocutory injunction independently reviewable under 28 U.S.C. § 1292 (a)(1). The contempt order, however, does purport to be based in part on defendants' non-compliance with the TRO.*fn8 Although this Court has no jurisdiction to entertain an appeal from the TRO, the validity of the TRO must nonetheless be examined for the limited purpose of our review of the Order for Civil Contempt*fn9 which the district court issued because of the defendants' failure to comply with the recall provisions of the TRO and Preliminary Injunction.*fn10
II. Validity and Scope of the Preliminary Injunction
Defendants have alleged a plethora of procedural defects in the district court proceedings. Most of these are wholly without merit, and the remainder, though in some respects disturbing, do not warrant reversal of the entire order granting the Preliminary Injunction. However, because several provisions of the Preliminary Injunction are far broader than the record justifies and others exceed the permissible scope of interlocutory relief, some portions of the Preliminary Injunction are invalid.
The prohibition of the manufacture and distribution of the Bitter Food Tablets or other amygdalin-containing articles in parts I and II of the Preliminary Injunction (and parts I and II of the TRO) are unobjectionable. The F.D.A. affidavits indicated that amygdalin is a food additive not on the list of additives generally recognized as safe ("GRAS") and is a new drug for which no new drug application is on file. Other affidavits concerning defendants' manufacture and distribution of the Bitter Food Tablets provided a sufficient basis for the district court's preliminary conclusions that defendants violated 21 U.S.C. § 331(a), (d) and (k) by virtue of their manufacture, distribution and ...