Appeal from the United States District Court for the Northern District of Illinois, Eastern Division. No. 83 C 6129-Susan Getzendanner, Judge.
Wood, Jr., Coffey, and Ripple, Circuit Judges.
This is an appeal from an order granting summary judgment in favor of the government in a forfeiture action*fn1 brought against certain quantities of toothpaste manufactured and distributed by the defendants, Block Drug Company, and Leonard and James Block (collectively referred to as Block). The government alleged that the toothpastes were "new drugs," and that, because no approved new drug application (NDA) regarding these articles was on file with the Food & Drug Administration (FDA), they were subject to forfeiture. The district court determined that no genuine issue of material fact existed as to whether the articles were "new drugs" under 21 U.S.C. § 321(p). We affirm the order of the district court.
On January 1, 1983, Block began to market Promise and Sensodyne-F (collectively referred to as Promise). Promise combines sodium monofluorophosphate (sodium MFP) and potassium nitrate. Block's purpose in combining these ingredients was to produce a single toothpaste that provided both protection against cavities (through sodium MFP) and relief from dentin hypersensitivity (through potassium nitrate). In this way, people with sensitive teeth could receive cavity protection and relief from hypersensitivity in a single brushing. At the time Block began to market the toothpaste, it had not filed an NDA for the products. Despite warnings from the FDA, Block continued to market the products.
The government brought multiple forfeiture actions against Block to seize and condemn the toothpaste. The government later amended its complaint to seek an injunction preventing Block from making further shipments of the toothpaste. The toothpaste mentioned in the complaint was seized on September 2, 1983. On September 26, 1984, the government filed a motion for summary judgment, or in the alternative, for a preliminary injunction. The district court granted the motion for summary judgment in an order issued November 20, 1985 and amended December 5, 1985. United States v. Articles of Drug . . . Promise Toothpaste, 624 F. Supp. 776 (N.D. Ill. 1985). On December 16, 1985, the district court declared the articles to be unapproved "new drugs," condemned them to be destroyed, and enjoined Block from further distribution of the toothpaste. R.77. Block moved for a stay judgment pending appeal on January 6, 1986. R.80. On April 25, 1986, the district court granted Block's motion for a stay, "subject to the condition that defendants place appropriate warning labels on the products." Appellee's App. at 85.
B. Statutory and Regulatory Framework
Under the Federal Food, Drug, and Cosmetic Act (the Act), a "new drug" may not be introduced into interstate commerce unless an approved NDA is on file with the FDA. 21 U.S.C. § 355(a). A drug is a "new drug" unless its manufacturer demonstrates that it is "generally recognized among experts" to be "safe and effective" for its recommended uses. 21 U.S.C. § 321(p)(1).*fn2 The safety and effectiveness of the drug must be established by "substantial evidence." Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 629, 37 L. Ed. 2d 207, 93 S. Ct. 2469, 2483 (1973). "Substantial evidence " is defined as:
evidence consisting of adequate and well -controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.
2. Over-the-Counter Drugs
The FDA regulations also establish criteria for determining whether a drug may be marketed over-the-counter (OTC) or must be restricted to use by prescription of a physician. An OTC drug must meet the "new drug" requirements set out in the preceding paragraphs. Additionally, it must meet the labeling requirements of the Act (i.e., it may not be misbranded)*fn3 and the FDA must find that the drug is safe for OTC use.
In 1972, the FDA established its OTC drug review. 21 C.F.R. § 330.10 sets forth "Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded." A drug so classified may be marketed without prior FDA approval. The OTC review established a system of expert panels for each of the various categories of OTC drugs. Under this procedure, a panel solicits information from interested parties and recommends a proposed monograph that states the conditions under which the panel would consider the drugs to be generally recognized as safe and effective and not misbranded. The FDA then reviews the panel's recommendation and publishes an advance notice of proposed rulemaking that allows for public comment. After any new information is considered, the FDA publishes a tentative order establishing the conditions under which a category of OTC drugs is generally recognized as safe and effective and not misbranded. After considering any further comments or objections, the FDA publishes a final monograph.
A "new drug" may be created by combining two or more drugs, neither of which is a new drug. 21 C.F.R. § 310.3(h)(2). Even if the component parts of the new drug may be generally recognized as safe and effective, the combination of those parts may not be safe. There is the possibility that the component drugs, when combined, may have a different effect from that of each component drug individually. See United States v. Articles of Food and Drug . . . Coli-Trol 80, 518 F.2d 743, 746 (5th Cir. 1975). As the court stated in Coli-Trol 80, "new combinations of well-known ...