MediNatura, Inc. v. Food & Drug Admin.

998 F.3d 931

MEDINATURA, INC., Appellant

v.FOOD & DRUG ADMINISTRATION, et al., Appellees

No. 20-5341

United States Court of Appeals, District of Columbia Circuit.

Argued March 24, 2021

Decided May 28, 2021

David B. Salmons argued the cause for appellant. With him on the briefs were Jason R. Scherr and Douglas A. Hastings.

Courtney L. Dixon, Attorney, U.S. Department of Justice, argued the cause for appellees. With her on the brief were Brian M. Boynton, Acting Assistant Attorney General, Scott R. McIntosh, Attorney, and Annamarie Kempic, Deputy Chief Counsel for Litigation, U.S. Food and Drug Administration.

Before: Henderson, Rogers and Wilkins, Circuit Judges.

Karen LeCraft Henderson, Circuit Judge:

The Federal Food, Drug, and Cosmetic Act (FDCA) regulates homeopathic drugs. A 1988 Food and Drug Administration (FDA) guidance document outlined the circumstances in which the FDA intended to exercise its discretion not to enforce the full force of the FDCA against homeopathic drugs. In October 2019, the FDA withdrew the guidance document. Shortly thereafter, the FDA added six of appellant MediNatura, Inc.’s prescription injectable homeopathic products to an import alert, notifying FDA field staff that the products appeared to violate the FDCA. MediNatura challenged both actions and sought preliminary injunctive relief to stop the withdrawal of the guidance as well as the enforcement of the import alert. The district court dismissed MediNatura's import alert-based claims, concluding the import alert was non-final agency action. It also declined to enjoin the withdrawal of the guidance because MediNatura failed to establish its entitlement to a preliminary injunction. As detailed infra , we affirm.

I. BACKGROUND

A. Statutory and Regulatory Background

The FDCA defines "drug" as, inter alia , (1) articles recognized in the "official Homoeopathic Pharmacopoeia of the United States"; (2) "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals"; and (3) "articles (other than food) intended to affect the structure or any function of the body of man or other animals." 21 U.S.C. § 321(g)(1). Under the FDCA, it is unlawful to distribute any "new drug" without FDA approval. Id. §§ 331(d), 355(a). A drug is a "new drug" if it is "not generally recognized ... as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof." Id. § 321(p)(1). Even if a drug is so recognized it remains a "new drug" unless it has been "used to a material extent or for a material time under such conditions." Id. § 321(p)(2). Therefore, if a drug is widely used or used for a substantial time and is generally recognized as safe and effective ("GRAS/E") it is not a "new drug" needing approval. To obtain approval for a new drug, a sponsor must submit a New Drug Application (NDA) to the FDA. Id. § 355(b). The FDA "implement[s] a structured risk-benefit assessment" in evaluating an NDA. Id. § 355(d).

Imported drugs are subject to the FDCA. Id. § 381(a). If an imported drug "appears" to violate the FDCA, it may be refused admission after FDA detention. Id. ; Joint Appendix (J.A.) 1227 (FDA Regulatory Procedures Manual (RPM)). Should a drug be detained, the FDA provides the importer notice and an opportunity to be heard. 21 C.F.R. § 1.94(a) ; J.A. 1266 (RPM). The importer may introduce testimony to demonstrate the admissibility of the drug. 21 C.F.R. § 1.94(a) ; J.A. 1266 (RPM). The FDA considers the testimony and then decides whether to release the drug or formally deny admission. 21 U.S.C. §§ 381(a), (b) ; J.A. 1266–67 (RPM). An importer may seek reconsideration from the FDA and ultimately judicial review. 21 C.F.R. §§ 10.33, 10.45.

B. FDA Regulation of Homeopathic Drugs

Homeopathy is an alternative medical practice "based on two unconventional theories": (1) " ‘[l]ike cures like’—the notion that a disease can be cured by a substance that produces similar symptoms in healthy people"; and (2) the " ‘[l]aw of minimum dose’—the notion that the lower the dose of the medication, the greater its effectiveness." Homeopathy, Nat'l Insts. of Health, https://www.nccih.nih.gov/health/ homeopathy (last updated Apr. 2021) (emphasis in original). Homeopathic drugs are subject to the FDCA requirement that any "new drug" must be approved. 21 U.S.C. §§ 321(g), 321(p), 331(d), 355(a). The FDA has never approved an NDA for a homeopathic drug nor found a homeopathic drug to be GRAS/E and thus not a "new drug" requiring an NDA. Instead, the FDA has exercised its enforcement discretion regarding the sale of homeopathic drugs through its 1988 Compliance Policy Guide 7132.15 § 400.400 "Conditions Under Which Homeopathic Drugs May be Marketed" (CPG 400.400). J.A. 218 (CPG 400.400). CPG 400.400 "delineate[d] those conditions under which homeopathic drugs may ordinarily be marketed in the U.S." Id. (emphasis added). The FDA announced its intention to "consider[ ] for regulatory followup" homeopathic drugs not in compliance with certain FDCA requirements—including labeling, packaging and manufacturing requirements. Id. at 223. CPG 400.400 did not exempt homeopathic drugs from approval requirements and, while CPG 400.400 was in place, the FDA took enforcement steps against certain unapproved homeopathic drugs.¹

In March 2015, the FDA announced that it was reevaluating its enforcement policies for homeopathic drugs, explaining that, since CPG 400.400's issuance, the homeopathic drug industry had expanded significantly and it had received numerous reports of "[n]egative health effects from drug products labeled as homeopathic." Homeopathic Product Regulation: Evaluating the Food and Drug Administration's Regulatory Framework After a Quarter-Century, 80 Fed. Reg. 16,327, 16,328 (Mar. 27, 2015). It then sought public input on its "current enforcement policies," including whether "the current enforcement policies under the CPG [are] appropriate to protect and promote public health." Id.

In December 2017, following its evaluation of CPG 400.400, the FDA announced that "in the best interest of public health," it intended to replace CPG 400.400 with a "risk-based" enforcement approach "consistent with FDA's risk-based regulatory approaches generally." Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry, 82 Fed. Reg. 60,403, 60,405 (Dec. 20, 2017). The proposed guidance (2017 Draft Guidance) identified categories of homeopathic products that posed higher risks and therefore a higher enforcement priority—including products that had reported safety concerns, that contained potentially harmful ingredients or that "pose[d] a greater risk of harm to users due to their routes of administration." J.A. 232 (2017 Draft Guidance). Notwithstanding the categories, the FDA noted that the guidance will "provide notice that any product labeled as homeopathic that is being marketed illegally is subject to FDA enforcement action at any time," id. , and that "[t]he continued marketing of products that have neither been approved by FDA nor found to be GRAS/E is a public health concern," id. at 230–31. The FDA stated that CPG 400.400 would be withdrawn once the new guidance issued. Drug Products Labeled as Homeopathic; Draft Guidance, 82 Fed. Reg. at 60,404.

In July 2018, the FDA received a citizen petition from Americans for Homeopathy Choice (Citizen Petition). The petition requested various actions from the FDA and, as relevant here, asserted that the homeopathic industry and its consumers had relied on CPG 400.400 for decades and that replacing it would upset that reliance interest. The FDA responded to the petition on October 24, 2019, stating that the reliance interest was overcome by the FDA's need to withdraw CPG 400.400 and noting reasons why. The next day, the FDA published notice—effective immediately—that it was withdrawing CPG 400.400. Compliance Policy Guide Sec. 400.400 Conditions Under Which Homeopathic Drugs May Be Marketed; Withdrawal of Guidance, 84 Fed. Reg. 57,439, 57,440 (Oct. 25, 2019). Since issuing CPG 400.400, it explained, the homeopathic industry had grown significantly and it had recently encountered "situations in which homeopathic products either caused or could have caused significant harm." Id. Because CPG 400.400 was "inconsistent with [the FDA's] risk-based approach to enforcement," it announced the withdrawal of CPG 400.400 at that time (notwithstanding the previous notice that the withdrawal would not occur until the 2017 Draft Guidance was finalized) as well as its intent to apply a general risk-based approach to enforcement until new guidance was finalized. Id. Also on October 25, 2019, the FDA published a new version of its draft guidance (2019 Draft Guidance) closely mirroring the 2017 Draft Guidance. See Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry, 84 Fed. Reg. 57,441 (Oct. 25, 2019).

C. Procedural History

MediNatura manufactures, imports and distributes homeopathic products, including six prescription injectable products manufactured in Germany (Products), all of which complied with CPG 400.400's requirements. In June 2020, the FDA issued a warning letter to MediNatura, noting the Products were "especially concerning from a public health perspective" because "[i]njectable products are delivered directly into the body ... bypass[ing] some of the body's key defenses" and the Products contained "potentially toxic or otherwise harmful ingredients." J.A. 399 (Warning Letter). The FDA explained that it considered the Products "unapproved new drugs" and that they could not be distributed without approval. Id. Six days later, the FDA added MediNatura's Products to Import Alert 66-41 (Import Alert), which lists products that "appear[ ] to be" unapproved new drugs in violation of the FDCA.² J.A. 405 (Import Alert).

On July 29, 2020, MediNatura filed suit...