How does the FDA regulate ivermectin use in humans in 2025?

1. What advocates and critics are claiming — and what the documents actually say

Public discourse has two recurring claims: that the FDA has never approved ivermectin for humans beyond parasitic infections, and that the agency has recently tightened or loosened access to ivermectin for COVID-19. The materials show both claims contain truth: historically the FDA approved ivermectin for intestinal strongyloidiasis, onchocerciasis, and certain dermatologic uses and has repeatedly declared it is not approved for COVID-19 ^{[2] [3]}. At the same time, the agency’s January 2025 approval of an Ivermectin Tablets USP under an abbreviated new drug application indicates the FDA continues to regulate and permit legally marketed human formulations — a technical development that does not equate to approval for COVID-19 treatment ^[1]. Those pushing expanded use frame recent approvals or state-level OTC moves as vindication, while public-health authorities emphasize the specific labeling and evidence limits the FDA has stated ^{[4] [1]}.

2. How the FDA enforces approved uses and fights improper claims

The FDA enforces its regulatory standards through product approvals, warning letters, and public advisories. The agency has issued enforcement actions against websites marketing ivermectin for COVID-19 and repeatedly warned the public that clinical trials have not demonstrated efficacy for prevention or treatment of COVID-19 and that animal products are unsafe for human use ^{[2] [3]}. These enforcement actions reflect the FDA’s dual mandate: allow legitimate, bioequivalent generic products to enter the market while preventing misleading claims that a product treats or prevents diseases without supportive data. The 2023 warning letter and persistent advisories illustrate ongoing agency activity focused on preventing off-label public uptake and counterfeit or mislabeled veterinary product use in humans ^{[2] [5]}.

3. Recent regulatory moves in 2025: approvals, labeling, and the legal framework

In early 2025 the FDA approved an Ivermectin Tablets USP application under the abbreviated new drug application route, citing bioequivalence to a previously marketed reference product, Stromectol, which was not withdrawn for safety or effectiveness reasons ^[1]. That approval shows the FDA’s standard pathways for generics remain operational; approval for a specific formulation or route does not constitute approval for COVID-19. The agency’s regulatory framework for related ivermectin formulations is also grounded in the Code of Federal Regulations, which includes provisions for ivermectin liquid and other dosage forms, clarifying manufacturing and labeling requirements under 21 CFR ^[6]. If Risk Evaluation and Mitigation Strategies were required historically, generics would face the same obligations, demonstrating continuity in oversight rather than policy reversal ^[1].

4. Conflicts at the state level and the role of pharmacists

Several states enacted laws expanding over-the-counter access to ivermectin in 2024–2025, generating friction between state policy and federal guidance and creating practical challenges for pharmacists balancing patient autonomy with evidence-based prescribing ^[4]. The FDA maintains that prescribing for unapproved indications remains a clinical decision, but warns against self-medication and use of veterinary products; state statutory changes that broaden OTC access complicate that message and may increase risks of inappropriate dosing and adverse events. Pharmacists must navigate these mixed signals, applying clinical judgment and patient education while the FDA continues public warnings that large or inappropriate doses can cause serious harm, including nausea, vomiting, and death ^{[3] [4]}.

5. The big picture: evidence gaps, public trust, and what the record shows

Across the documents, the consistent factual thread is that the FDA has not found clinical-trial evidence supporting ivermectin for COVID-19 and continues to warn against such use, even as it authorizes or approves certain human formulations through normal drug-approval pathways and enforces against false claims ^{[3] [1] [2]}. The tension between approvals of generic, bioequivalent products and persistent public misinformation has strained trust in public-health institutions; the FDA and CDC have publicly tied their guidance to trial evidence and safety data while noting the challenge of combating misinformation ^[5]. The record shows regulatory continuity: legal, labeled human uses remain available; off-label promotion for COVID-19 is disallowed; and the FDA uses approval, labeling, enforcement, and public communication tools to manage both legitimate access and misuse ^{[1] [2] [3]}.