FDA Homeopathic Registration: What You Need to Know

What is a Homeopathic Drug?

Homeopathy is an alternative medicine that has experienced a significant surge in popularity in recent years. This has contributed to the growth of the US homeopathic market, which is estimated to be a $3 billion industry. Homeopathic products are typically derived from various natural sources, including plants, minerals, and animals. They are frequently promoted as natural, safe, and effective alternatives to approved prescription and over-the-counter medications.

The central notion of homeopathy is based on two fundamental principles: “like cures like,” where a substance that causes symptoms in a healthy person can treat similar symptoms in a diluted form, and the “law of infinitesimals,” which suggests that the more diluted a substance is, the more potent it becomes. Below, you will find out about the FDA homeopathic registration process.

Homeopathic as OTC Drugs

In the United States, homeopathic products are sold over-the-counter (OTC) and come in various forms, including capsules, creams, drops, granules, liquids, lozenges, nasal sprays, tablets, suppositories, and syrups. The potency of these products is indicated on the label immediately after the product name, typically shown as a number followed by either an “X” or a “C”. This number represents the number of times the homeopathic medicine has been diluted, while X and C denote the dilution ratios (1/10 for X and 1/100 for C).

How Homeopathic Drugs are Regulated in the U.S.?

Homeopathic ingredients sold in the United States are evaluated by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS) for homeopathic efficacy, toxicology, adverse effects, and clinical use. Those that meet the standards are listed (monographed) in the Homeopathic Pharmacopoeia of the United States (HPUS). The FDA classifies a drug as homeopathic if it uses ingredients listed in the Homeopathic Pharmacopeia of the United States (HPUS).

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), homeopathic products are subject to the same requirements as other drugs, including approval, adulteration, and misbranding. However, it is essential to note that the FDA has not approved homeopathic products; instead, they are being registered and listed in a manner similar to over-the-counter (OTC) drugs.

FDA Homeopathic Registration Requirements & Steps

FDA homeopathic registration is a crucial step for establishments involved in the manufacturing, preparing, or processing of homeopathic drugs sold in the U.S. The registration process also requires listing homeopathic products with the FDA and ensuring adherence to FDA standards, which are similar to those for OTC drugs. The registered establishment must renew its registration annually before the end of every year. Likewise, the OTC listing must be renewed (re-certified) between October 1st and December 31st. The registration process for Homeopathic OTC involves the following four steps:

OTC Drug Establishment Registration
Obtaining Labeler Code (5-digit code)
OTC Homeopathic Label Compliance
OTC Homeopathic Drug Listing (NDC assignment)

Upon completion of registration, a homeopathic item will receive a 10-digit NDC code, which will be published in the FDA NDC Directory. Unlike those manufacturing OTC monograph items, facilities producing homeopathic products are not subject to the FDA’s annual user fee (OMUFA).

Homeopathic registration may be different in different parts of the world. For example, to register a homeopathic drug in the EU, a detailed dossier with quality, safety, and efficacy data, including labeling information, must be submitted to the relevant authority or the EMA, reviewed, and marketing authorization obtained.

Homeopathic Drug Labeling Requirements

All homeopathic products in the United States must comply with specific labeling requirements set by the FDA. A homeopathic drug label must follow FDA OTC drug requirements, including a drug fact panel reflecting active and inactive ingredients, warnings, uses, directions for use, etc.

Additionally, labels must clearly identify the product as homeopathic, include the active ingredients and their dilution levels, list the intended use or purpose (unless exempt), and provide adequate directions for use. Additionally, all claims must be truthful and not misleading, particularly since the FDA has not evaluated most homeopathic products for efficacy.

FDA Enforcement

Homeopathic products are regulated under federal law like other drugs, but they have not been FDA-approved for any use and may not meet modern safety, effectiveness, and quality standards. To protect the public from potentially unsafe homeopathic products FDA will employ a risk-based enforcement approach, prioritizing action against products that:

Have reports of injury or safety concerns
Contain potentially harmful ingredients
Are administered in ways other than orally or topically (e.g., eye drops, nasal sprays)
Claim to treat serious diseases like cancer
Target vulnerable groups (children, pregnant women, elderly)
Have significant quality issues

Please call or email us if you need assistance with FDA homeopathic registration for your homeopathic products. Our FDA experts will assess your products and provide you with the necessary information and steps.

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