UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA MEDINATURA, INC., Plaintiff, v. Civil Action No. 20-2066 (RDM) FOOD AND DRUG ADMINISTRATION et al., Defendants. MEMORANDUM OPINION AND ORDER This case concerns the Food and Drug Administration’s (“FDA”) regulation of homeopathic drugs. For many years, the FDA did not regulate homeopathic drugs at all, promising to get around to them eventually. Then in 1988, to bring homeopathic drugs into at least partial compliance with the Federal Food, Drug, and Cosmetic Act (“FFDCA” or “Act”), the FDA issued Compliance Policy Guide 7132.15, Section 400.400 (“CPG 400.400” or “Policy”). CPG 400.400 established conditions under which homeopathic drugs could “ordinarily” be marketed without the FDA’s premarket approval, so long as the drugs complied with statutory and regulatory requirements for labeling, manufacturing, and registration. Three decades later, as part of an ongoing effort to change the regulatory framework that applies to homeopathic drugs, the FDA withdrew CPG 400.400 in 2019. Plaintiff MediNatura, Inc. is a purveyor of homeopathic products, including six prescription injectable drugs that it imports from Germany. In June 2020, following the withdrawal of the Policy, the FDA sent MediNatura a warning letter asserting that its injectable products violated the FFDCA. The agency also added the products to an Import Alert 1 recommending that officials detain them at the border. MediNatura filed this lawsuit challenging the withdrawal of CPG 400.400 and the Import Alert and sought a preliminary injunction. In response, the FDA moved to dismiss. For the following reasons, the Court will GRANT in part and DENY in part the FDA’s motion to dismiss and will DENY MediNatura’s motion for preliminary injunction. I. BACKGROUND A. Statutory and Regulatory Background 1. The FDA’s Regulation of New Drugs The FFDCA requires drug manufacturers to secure approval from the FDA before marketing any new drug. 21 U.S.C. § 355(a). The FFDCA defines “drug” to include, inter alia, articles recognized in either the “official United States Pharmacopœia” or the “official Homœopathic Pharmacopœia of the United States” (“HPUS”); articles intended for the “diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;” and articles, other than food, “intended to affect the structure or any function of the body of man or other animals.” Id. § 321(g). The Act defines “new drug,” in turn, as any drug “the composition of which is such that [it] is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof.” Id. § 321(p). Even if a drug is so recognized, it is still a new drug if it has not “been used to a material extent or for a material time under such conditions.” Id. In other words, the FFDCA exempts drugs that are already in the marketplace and generally recognized as safe and effective (“GRAS/E”) from the requirements for new drugs. 2 The primary means for a drug manufacturer to obtain ...
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