The short answer
In the U.S., a product labeled “homeopathic” is a drug. FDA’s December 2022 final guidance says homeopathic products must meet the same legal requirements as other drugs, and that none are FDA-approved — so they are sold without the required approval, under a risk-based enforcement policy.
That means the manufacturer still needs drug establishment registration, an NDC and drug listing, drug CGMP and a Drug Facts-style label — and must stay out of the categories FDA has said it will target first.
What FDA treats as a homeopathic drug product
A drug product labeled as “homeopathic” and labeled as containing only active ingredients and dilutions listed in the Homeopathic Pharmacopeia of the United States (HPUS).
FDA’s enforcement priorities
| Category | Example |
|---|---|
| Reports of injury that raise potential safety concerns | Adverse event reports linked to a product |
| Ingredients associated with potentially significant safety concerns | Low dilutions of toxic plants or heavy metals |
| Routes other than oral and topical | Injectables, eye drops, nasal sprays, inhalants |
| Serious or life-threatening diseases or conditions | Products for cancer, heart disease, infections |
| Vulnerable populations | Infants and children, pregnant women, the elderly |
| Significant quality issues | Facilities with significant CGMP deviations, contamination |
What a foreign homeopathic manufacturer needs
- 1Drug establishment registrationWith a U.S. Agent, renewed each year between October 1 and December 31.
- 2NDC labeler code and drug listingEach product listed with FDA in SPL format. See NDC numbers for OTC drugs.
- 3Drug CGMP21 CFR parts 210 and 211 — quality unit, batch records, testing, stability, sterility for eye products.
- 4LabelingIndications for self-limiting conditions only, ingredients with HPUS dilutions, directions and warnings in a Drug Facts-style panel.
- 5Adverse event reportingSerious adverse events from nonprescription drugs must be reported to FDA within 15 business days, and the label needs a U.S. address or phone number.
Example: a homeopathic maker in Germany
A German company makes oral pellets for minor sleeplessness and a topical arnica gel for muscle aches. It registers its factory as a drug establishment, gets an NDC labeler code and lists both products, and works to drug CGMP. It decides not to export its homeopathic eye drops or its infant colic drops, because both fall within FDA’s enforcement priorities, and it keeps all claims to self-limiting conditions.
Drug registration, NDC labeler code and U.S. Agent $550 per year. Drug listing $350 per drug. Drug label review $550.
Frequently asked questions
Are homeopathic products FDA-approved?
No. FDA says homeopathic products are drugs that are marketed without the required approval, under a risk-based enforcement policy.
Do homeopathic products need drug registration and an NDC?
Yes. They are drugs, so the manufacturer registers as a drug establishment and lists each product.
Which homeopathic products does FDA target first?
Products with safety signals, risky ingredients, non-oral and non-topical routes (such as eye drops and injections), products for serious diseases or vulnerable populations, and products with significant quality problems.
Does HPUS listing make a product legal?
No. HPUS listing defines what is homeopathic; it is not FDA approval.
Sources
- FDA — Homeopathic drug products: guidance for FDA staff and industry (December 2022)
- FDA — Full text of the homeopathic guidance (enforcement priorities and definition)
- FDA Law Blog — FDA finalizes enforcement policy for homeopathic drugs (December 2022)
Requirements checked on November 12, 2026. This article is general information, not legal advice.