Court Decision Dilutes Hopes of Homeopathic Industry for New Regulatory Pathways

One familiar with homeopathy might reasonably think that the practice would have a place in the Make America Healthy Again movement as an alternative to conventional pharmaceutical treatment. But after a recent court decision issued on July 15, 2025, the regulatory path for homeopathic medicine looks murkier than ever.

Homeopathy operates on the principle that “like cures like,” where practitioners use heavily diluted substances intended to cause the symptoms they are meant to treat. For decades, FDA largely ignored this $6 billion industry through a 1988 compliance policy guide (CPG) that essentially created a regulatory “safe harbor” for over-the-counter homeopathic products. Although they were unapproved new drugs, the CPG described the conditions under which FDA would allow these unapproved drugs to be on the market.

In 2015, FDA indicated that it increasingly was concerned about the safety of homeopathic drugs, and it claimed that the existence of the CPG limited its options to take enforcement action. In 2019, the agency withdrew that CPG and issued draft guidance describing its new risk-based enforcement policy to replace the CPG.  In 2022, it finalized this new enforcement guidance for homeopathic drug products.

In an effort to legitimize homeopathic drugs, the Americans for Homeopathic Choice Foundation (AHCF) submitted a petition requesting, among other things, recognition by FDA that homeopathic drugs, properly manufactured and labeled, and evaluated by appropriate standards, do not meet the legal definition of “new drugs,” and therefore were not subject to premarket review other than satisfying the requirements of current or likely inclusion in the HPUS. As we previously reported, FDA denied that petition one day before it issued the 2022 final guidance. As of that one-two punch, homeopathic remedies no longer enjoyed the benefits of FDA’s exercise of enforcement discretion from new drug approvals. As discussed in the 2022 guidance, FDA considers all homeopathic drugs to be new drugs, which can be taken off the market at any time for lack of approval. That said, enforcement actions against these unapproved drugs are generally based on safety considerations.

In 2024, the Alliance for Natural Health USA (ANH) and homeopathic drug distributor Meditrend , challenging the agency’s 2022 denial of the petition and arguing that FDA lacked authority to subject all homeopathic products to costly and lengthy new drug approval requirements. The CARES Act excluded homeopathic products from its reform of the OTC drug review process, and FDA and the homeopathic industry interpreted that absence from two opposing perspectives. FDA read the CARES Act exclusion to mean that Congress wanted to treat homeopathic drugs as unapproved new drugs. In contrast, the plaintiffs read the exclusion as evidence that Congress hoped to ease the path of homeopathic drugs to market.

Additionally, the plaintiffs challenged FDA’s guidance regarding enforcement priorities for (unapproved) homeopathic drugs as arbitrary and capricious.  Specifically, plaintiffs argued that the guidance violated their constitutional due process rights and was based on what the plaintiffs called “unsupported” safety concerns. Plaintiffs also claims that FDA’s concerns about safety of homeopathic drug product were insufficient reason to deny the AHCF petition.

The court dismissed most of plaintiffs’ claims outright. It found that FDA’s 2022 guidance document was not legally enforceable as final agency action and therefore could not be challenged under the Administrative Procedure Act. The court also rejected the constitutional due process claims and the statutory arguments that the plaintiffs raised about the CARES Act, ruling that Congress never intended to exempt homeopathics from standard drug approval requirements.

However, the court held open the question about whether FDA’s safety concerns about homeopathic practice were sufficient to justify the denial of the 2022 petition. It could not make a determination without a full administrative record; the “agency’s safety concerns may well be warranted. But whether they justify increased enforcement is a factual, not legal, determination. Therefore, the Court cannot reach a decision without a full record.”

For FDA, the ruling validates its revised risk based approach regarding homeopathic drugs. Plaintiffs promise to challenge FDA’s “attempt to regulate homeopathic medicines as conventional drugs” to the extent the decision allows, and the survival of the question of whether FDA had sufficient safety concerns to deny the petition keeps the door open for meaningful judicial review of that issue. We will be monitoring further developments.