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# Homeopathic Drug Marketer Can Challenge FDA Policy: Court
- URL: https://www.fdaweb.com/homeopathic-drug-marketer-can-challenge-fda-policy-court/
- Published: 2020-10-27T12:00:00.000Z
- Updated: 2026-09-14T16:34:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147963

The Washington, DC District Court has ruled that a recent FDA decision to remove a decades-old compliance policy affecting unapproved homeopathic drugs can be challenged in court. In *Medinatura v. FDA*, homeopathic product marketer MediNatura challenged the agency’s withdrawal of Compliance Policy Guide 7132.15, Section 400.400, which established conditions where homeopathic drugs could “ordinarily” be marketed without FDA’s premarket approval, so long as the drugs complied with statutory and regulatory requirements for labeling, manufacturing, and registration. The lawsuit also challenged an import alert that impacted injectable drugs that the company imports from Germany.

The [court’s opinion](https://ecf.dcd.uscourts.gov/cgi-bin/show%5Fpublic%5Fdoc?2020cv2066-27&ref=fdaweb.com) found FDA’s withdrawal of CPG 400.400 constituted a final agency action and is “ripe for judicial review” because it “removed the set of regulatory conditions under which unapproved homeopathic drugs were marketed for three decades.”

Additionally, the court agreed with FDA’s argument that the import alert is not a final agency action because it “does not represent the culmination of the agency’s decision-making process.” It also agreed with FDA that the import alert is non-binding and therefore does not determine legal rights or obligations. Thus the import alert was found not ripe for judicial review.