WASHINGTON (LN) — U.S. District Judge Christopher R. Cooper on Thursday granted summary judgment for the federal government in a suit brought by a homeopathy advocacy group and a homeopathic drug distributor, ruling the plaintiffs lacked standing to challenge the FDA's 2022 denial of an industry citizen petition because their alleged harms traced back to an earlier agency action they never challenged.
Alliance for Natural Health USA and Meditrend, Inc. filed suit in 2024 arguing the FDA acted arbitrarily and capriciously when it denied a citizen petition filed by Americans for Homeopathy Choice Foundation seeking presumptive safety determinations for homeopathic drugs and assurances against enforcement. The petition denial came alongside the FDA's 2022 final enforcement guidance, which formalized a risk-based approach the agency had been moving toward since it revoked its longstanding permissive compliance policy — known as CPG 400.400 — in 2019.
Cooper had already dismissed most of the case in July 2025, leaving only the arbitrary-and-capricious challenge to the petition denial. At that earlier stage, he held Meditrend had done just enough to establish standing based on a declaration from the company's founder, Richard Savage, who stated that Whole Foods had cancelled Meditrend's involvement in a large sales initiative and removed its products from stores due to the FDA's revocation of CPG 400.400 and unspecified agency actions against the homeopathic industry. Cooper warned then that a plaintiff's burden to demonstrate standing increases over the course of litigation and that more specific evidence would be required at summary judgment.
Mediatrend did not deliver it. Despite the court's explicit warning, the company offered no new evidence about Whole Foods' decision and continued to rely on the same Savage declaration. Cooper held that declaration fatally deficient because it identified the 2019 revocation of CPG 400.400 — not the 2022 petition denial — as the cause of Whole Foods' actions. Setting aside the petition denial, he wrote, would not affect the repeal of CPG 400.400.
Mediatrend tried a second angle at summary judgment, submitting a new Savage declaration attributing supplier price increases to the FDA's enforcement shift. Attached were letters from two ingredient suppliers, Apotheca, Inc. and Grato Holdings, documenting rising costs. But Cooper held that those letters pointed the same direction: toward the 2019 CPG revocation and the 2017 draft enforcement guidance, not the 2022 petition denial. The Apotheca letters cited intensifying scrutiny and concern from the FDA and pandemic-era supply chain disruptions. The Grato Holdings letter, Cooper noted, linked price increases to the revocation and the finalization of the enforcement guidance — events that predated the challenged action by years.
Plaintiffs argued in briefing that the petition denial was part of an overall FDA course of conduct that continued to injure Meditrend, but Cooper rejected that framing, noting that counsel's unsupported assertions in briefing are inadequate to meet the burden of proof to demonstrate standing.
The Court appreciates that the homeopathic industry continues to chafe from the FDA's shift from a permissive to a more risk-based enforcement posture, Cooper wrote. But that shift began over a decade ago. And its consequences were felt with the revocation of CPG 400.400. Plaintiffs cannot use it to seek redress of injuries that were allegedly caused by the FDA's prior actions.
The FDA has never approved a homeopathic drug as a new drug, nor found any homeopathic product to be generally recognized as safe and effective — meaning the entire industry has operated for decades under enforcement discretion rather than formal approval.
Mediatrend's window to challenge the 2019 CPG revocation — the agency action Cooper identified as the actual source of the company's injuries — has long since closed.