Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—D.D.C.: Whole Foods’ decision to pull homeopathic products not traceable to FDA’s petition denial, (Apr 28, 2026)

By Jeffrey H. Brochin, J.D.

Setting aside the FDA’s denial of a trade group’s citizen petition would not affect the repeal of the agency’s prior compliance policy guide.

A federal district court in the District of Columbia has denied the motion for summary judgment filed by Alliance for Natural Health (ANH) and Meditrend, Inc. in a lawsuit brought against the FDA alleging that new guidance as to homeopathic drugs, and denial by the FDA of a citizens’ petition, violated the Administrative Procedure Act (APA) and Fifth Amendment. Although ANH’s declaration made sufficient allegations to establish standing at the motion to dismiss stage, that same declaration was deemed insufficient to support standing at the subsequent motion for summary judgment stage due to conclusory statements as to the elements of traceability and redressability (Alliance for Natural Health USA v. United States of America, No. 24-cv-2989 (CRC) (D.D.C. Apr. 24, 2026)).

Historic lack of enforcement. Homeopathic drugs are subject to the requirement in the federal Food, Drug, and Cosmetic Act (FDC Act) that all “new drugs” must be approved by the FDA before they can be marketed for sale. However, the FDA has never approved a homeopathic medicine as a new drug, nor has it found a homeopathic drug to be “generally recognized as safe and effective” (GRAS/E) and therefore not a “new drug” requiring approval. Historically, the FDA 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). That policy effectively created a safe harbor for homeopathic drug producers such that, as long as producers followed certain conditions, they could market their drugs without FDA approval.

End of hands-off approach. The FDA’s hands-off approach began to shift in 2015 when the agency announced it would reevaluate CPG 400.400 in response to reports of adverse health effects from medicines labeled as homeopathic. The ensuing reassessment resulted in the issuance of draft enforcement guidance in 2017 and the revocation of CPG 400.400 in 2019.

In 2022, the pro-homeopathy advocacy group Americans for Homeopathy Choice Foundation (AHCF)—not a party to the instant lawsuit—filed a citizen petition for rulemaking requesting presumptive GRAS/E determinations for homeopathic drugs and assurances against enforcement. However, in December of that year, the FDA denied AHCF’s petition and published final enforcement guidance.

ANH, Meditrend lawsuit. ANH and Meditrend brought the instant lawsuit in 2024, alleging that the final guidance and the denial of AHCF’s petition violated the APA and the Fifth Amendment. The FDA moved to dismiss the lawsuit for lack of standing, lack of subject matter jurisdiction, and failure to state a claim. The court at that time ruled that ANH and Meditrend had done “just enough” to establish standing at the motion to dismiss stage by plausibly asserting (in an affidavit from Meditrend’s founder) that Whole Foods had removed the company’s products from its stores due to the FDA’s revocation of CPG 400.400 and other unspecified “actions against the homeopathic industry” (see FDA escapes most challenges to homeopathic drug crackdown (July 21, 2025)). Notably, the court warned Meditrend at that time that at summary judgment, they would need to come forward with additional evidence showing that Whole Foods’ purported about-face was traceable to the specific agency actions being challenged: the 2022 petition denial and final guidance. Presently before the court were the cross-motions for summary judgment filed by ANH and Meditrend and the government.

Traceability and redressability. The government renewed its standing argument, insisting that the petition denial was not arbitrary and capricious given the ample reports of safety concerns documented in the administrative record. Furthermore, it did not contest that ANH and Meditrend asserted concrete injuries; rather, it contended that the purported harms were not traceable to the FDA’s 2022 denial of AHCF’s petition and therefore could not be redressed by its vacatur.

The court agreed with the government that neither the traceability nor redressability prongs necessary for Article III standing were satisfied. Meditrend’s founder had stated in his declaration in 2023 that Meditrend had been invited by Whole Foods to join a large sales initiative. However, the declaration asserted that due to the FDA’s revocation of CPG 400.400, as well as unspecified agency “actions against the homeopathic industry,” Whole Foods cancelled Meditrend’s involvement in the global initiative and removed all Meditrend products from its stores. The court read the phrase “actions against the homeopathic industry” generously to include the agency actions challenged in the complaint—i.e., the denial of AHCF’s petition and the final guidance.

Sufficient for then—but not now. The court noted that although the assertions in the declaration were deemed sufficient to allege standing at the motion to dismiss stage, Meditrend had been cautioned at the time as to reliance on those assertions for summary judgment. Specifically, additional facts would need to be asserted at summary judgment; but despite such warning, Meditrend still relied on the same declaration at the current stage, to support standing, offering no new evidence concerning Whole Foods’ actions.

The conclusory statements in the declaration did not meet the requirements of traceability or redressability that the court needed to consider in weighing a motion for summary judgment. The most critical deficiency was that the declaration focused mainly on the repeal of CPG 400.400—which was the only specific cause for Whole Foods’ purported actions that the declaration identified—however, setting aside the denial of AHCF’s petition would not affect the repeal of CPG 400.400. Accordingly, the court found that Whole Foods’ purported decision to pull Meditrend’s products was not traceable to the petition denial and granting judgment in ANH and Meditrend’s favor would not redress whatever harm Whole Foods caused.

Two final agency actions. The court stated that while it appreciated that the homeopathic industry continued to “chafe” from the FDA’s shift from a permissive to a more risk-based enforcement posture, that shift began over a decade ago. And, its consequences were felt with the revocation of CPG 400.400, which was a final agency action that the industry was free to challenge. The subsequent denial of AHCF’s citizen petition—although also a final agency action subject to review—could not be used to seek redress of injuries that were allegedly caused by the FDA’s prior actions. Accordingly, ANH and Meditrend lacked standing and summary judgment was granted to the government.

The case is No. 24-cv-2989 (CRC).

Judge: Cooper, C.

Attorneys: Jonathan W. Emord (Emord & Associates, P.C.) for Alliance for Natural Health USA. James William Harlow, U.S. Department of Justice, for the U.S.

Companies: Alliance for Natural Health USA

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