The FDA’s recent policy shift regarding homeopathic drugs was recently supported by the D.C. Circuit Court of Appeals in MediNatura v. FDA, No. 20-5341 (D.C. Cir. 2021), when it upheld the denial of a preliminary injunction to block the FDA from withdrawing a longstanding enforcement policy regarding homeopathic drug products.
Plaintiff MediNatura manufactures and sells multiple homeopathic drug products. Recently, MediNatura challenged the FDA’s 2019 withdrawal of a 1988 FDA policy that required homeopathic drug manufacturers to follow federal labeling, packaging, and manufacturing requirements, while allowing them to market the products without demonstrating safety and efficacy. The FDA withdrew the policy in 2019 after finding it was no longer consistent with its risk-based approach.
Background: Homeopathic Drug Industry and FDA Regulation
Homeopathy is an alternative medical practice developed in the late 1700s based on two principles: (1) that a substance that causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses (a principle known as “like-cures-like”); and (2) the more diluted the substance, the more potent it is. Homeopathic drugs are often marketed as “natural, safe and effective” alternatives to prescription and nonprescription products.
While homeopathic drugs are included in the statutory “drug” definition under the Federal Food, Drug, and Cosmetics Act (FDCA), the FDA had, since 1988, exercised “enforcement discretion” for homeopathic drugs pursuant to FDA’s Compliance Policy Guide 7132.15, Section 400.400, (“CPG 400.400”). 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 other requirements for labeling, manufacturing, and registration.
Historically, homeopathic products were a small niche market, but they have recently become a nearly $3 billion industry in the United States. The FDA noted a corresponding increase in safety concerns, adverse events, and manufacturing concerns. Accordingly, on March 27, 2015, the FDA announced that it would evaluate its regulatory framework for homeopathic drug products, citing the growing popularity of homeopathic products and its awareness of numerous reports of negative health effects.
In 2018, Americans for Homeopathy Choice petitioned FDA to either keep CPG 400.400 or convert it into a regulation to allow for the continued marketing of homeopathic drug products, asserting that consumers and homeopathic drug manufacturers had relied on CPG 400.400 for decades.
On October 24, 2019, the FDA announced that it would withdraw CPG 400.400 and issued revised draft guidance titled Drug Products Labeled as Homeopathic, noting it had confronted “multiple situations in which homeopathic drug products posed a significant risk to patients” even though the product labels met the requirements of CPG 400.400. It concluded that CPG 400.400 was no longer consistent with the FDA’s risk-based approach.
MediNatura v. FDA
On June 11, 2020, the FDA issued a warning letter to MediNatura, warning that six of its injectable homeopathic drug products were unapproved new drugs under the FDCA and that they could pose serious harm to users. On June 17, 2020, the FDA added MediNatura’s six prescription injectable products to an Import Alert.
In response, MediNatura filed suit against the FDA. MediNatura argued that the FDA: (1) arbitrarily and capriciously withdrew CPG 400.400 without considering reliance interests or possible alternatives; (2) improperly added its products to the Import Alert without following the Administrative Procedure Act (APA); and (3) arbitrarily and capriciously added the products to the Import Alert without explanation. MediNatura further sought a preliminary injunction to enjoin the FDA from enforcing the Import Alert and from withdrawing CPG 400.400.
In opposition, the FDA argued that the withdrawal of CPG 400.400 and the addition of MediNatura’s products to the Import Alert did not constitute final agency action. The FDA also asserted that the withdrawal of CPG 400.400 was unreviewable under the Administrative Procedure Act. Finally, the FDA asserted that MediNatura lacked standing to pursue its claims.
On October 23, 2020, the district court held that the Import Alert was not final agency action and dismissed the claims concerning the Import Alert. Considering the challenge to the CPG withdrawal, the court rejected the FDA’s argument that it was a discretionary enforcement action, stating that “CPG 400.400 . . . represented a decades-long compromise designed to induce homeopathic drug manufacturers to submit to regulation of their labeling, manufacturing practices, and the like in exchange for the FDA’s affirmation that those manufacturers could ‘ordinarily’ market their products in the United States.”
The District Court then considered MediNatura’s motion for a preliminary injunction. While the District Court disagreed with the FDA’s contention that it did not need to consider reliance interests at all, it agreed with the FDA’s alternative argument – that it had sufficiently considered reliance interests when reviewing the citizen petition from Americans for Homeopathy Choice. There, the FDA had acknowledged the reliance concerns, but found the recent volume of safety concerns compelling, noting that “[w]here the public health is concerned, the Court owes the FDA’s scientific and medical judgment great deference.”
The district court also held that MediNatura had not shown a likelihood of success on the merits regarding its claim that the FDA failed to consider alternatives, noting that the change in policy was not a “seismic shift,” and citing the FDA’s focus on the drugs that pose the greatest risk to the public—namely, injectable drugs.
On May 28, 2021, the D.C. Circuit affirmed, agreeing that the FDA had adequately considered and addressed reliance interests. It also rejected MediNatura’s assertion that the FDA did not adequately consider alternatives to withdrawing CPG 400.400, noting that its suggestion of creating a separate approval process specifically for homeopathic drugs was not a viable alternative due to the safety concerns the FDA raised.
In withdrawing CPG 400.400, the FDA has signaled its intent to more closely regulate the marketing and sale of homeopathic drug products. Going forward, homeopathic drug manufacturers will likely need to comply with some of the same other policies as other drug manufacturers, or be subject to new legislation, in order to sell their products in the United States.