Q: What is a homeopathic drug and how does this category differ from other drug categories and from dietary supplements?
A: You probably have seen homeopathic drugs displayed at Natural Products Expo East or West and in health food stores. Maybe you were surprised to see the phrase homeopathic remedy. Homeopathics are in these venues because they qualify as natural health products and complementary medicine, plus they often use herbal ingredients. Homeopathic drugs are defined as a separate drug category by the Food and Drug Administration, distinct from both over-the-counter and prescription drugs. Homeopathics do treat disease and thus are different from dietary supplements, which are for health maintenance. Dietary supplements manufacturers may not make disease or drug claims.
The term homeopathy is derived from the Greek words homeo (similar) and pathos (suffering or disease). The practice of homeopathy is based on the belief that disease can be cured with very small, diluted doses of substances that produce symptoms similar to the disease in healthy people. The potencies of homeopathic drugs are specified in terms of dilution: 1x means 1/10 dilution, 2x is a 1/100 dilution, 3x is a 1/1,000 dilution and so on.
Q: Are homeopathic drugs OTC or prescription drugs?
A: They can be either—the distinction is as follows. A homeopathic drug that is not safe without the supervision of a licensed practitioner because of its toxicity, its potential for harmful effects, its method of use or the collateral measures necessary for its use is a prescription drug. The Homeopathic Pharmacopoeia of the United States designates which homeopathic drugs meet those requirements. The FDA published Conditions Under Which Homeopathic Drugs May Be Marketed (Compliance Policy Guide 7132.15) in 1988. Homeopathic products intended solely for temporary, nonserious disease conditions amenable to symptom self-diagnosis and to treatment by the consumer may be marketed as OTC drugs. The label must include at least one major OTC indication stated in terms a layperson will understand.
Q: What are some examples of OTC homeopathic drugs? What forms may they take?
A: Examples include backache creams; tablets for bumps and bruises; remedies for colic or teething; tablets for earache, leg cramps or colds. For example, there is a well-known zinc nasal spray on the market advertised to limit the duration of the common cold. Homeopathic drugs are sold in liquid or tablet form. It is also legal to sell a homeopathic drug in topical cream form if it is intended to have a localized effect and if it is labeled as a topical.
Q: What are the regulations governing the ingredients that may be used in a homeopathic drug and its manufacture?
A: The ingredients are largely governed by HPUS. Homeopathic drugs generally must meet the standards for strength, quality and purity set forth in HPUS. Since its enactment in 1938, many doctors, lawyers and FDA officials have questioned the inclusion of HPUS in the Federal Food, Drug and Cosmetic Act. Its sponsor, Royal Copeland, who served in the Senate in the mid-1920s, was a homeopathic physician and was responsible for writing HPUS into the legislation.
A homeopathic drug must be manufactured according to homeopathic principles, and all firms that manufacture, prepare, propagate, compound or otherwise process homeopathic drugs must register as drug establishments. A homeopathic drug must also be shown by appropriate means to be safe, effective and not misbranded for its intended use.
Q: To avoid a misbranding charge, what are the main labeling requirements for an OTC homeopathic drug?
A: The principal display panel, the label's front panel, has the following requirements:
- Size: Must be large enough to clearly and conspicuously fit all required information.
- Statement of identity: The established name of the drug, followed by a statement that the drug is a homeopathic drug or remedy.
- Net content: weight or volume of contents.
Labels are also required to contain the following:
- Name and place of business of the manufacturer, packer or distributor.
- Directions for use must include all of the following information when relevant: uses, dosage, frequency, duration, time of administration in relation to specific factors (for example, before meals, at onset of symptoms), method of administration (for example, orally, topically) and preparation for use (shake before using, for example).
- Statement of ingredients: Must include the established name of the active ingredients (the name listed in the HPUS), along with the quantity, expressed in homeopathic terms (12x, for example). If the established name is in Latin, the common English name (if any) must appear, while the Latin name is allowed to appear also. Inactive ingredients should be listed in alphabetical order separately from active ingredients.
Q: Are any warnings required on OTC homeopathic drugs?
A: It depends on what is appropriate for that product. If the product is intended for systemic absorption, the label must include the following warning unless specifically exempted: "If pregnant or nursing, ask a health professional before using." It must also include warnings that conform to OTC drug monograph requirements when applicable, for example, "do not use" followed by all product contraindications. These contraindications are intended for situations when consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations when certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted. If appropriate, include the "keep out of reach of children" and the accidental overdose/ingestion warnings.
Q: Is there any interesting history to homeopathic drugs?
A: Yes, there is. Samuel Hahnemann, a physician and chemist, formulated the basic principles of homeopathy in the late 1700s. Homeopathy began when Hahnemann discovered that Peruvian bark, which contains quinine, was effective for treating malaria. Hahnemann decided to test the physiological effects of Peruvian bark on a healthy person—himself. He soon developed symptoms similar to those of malaria, making him wonder if the bark's curative power resulted from its ability to create similar disease symptoms, and hence the law of similars. Hahnemann then experimented with different amounts of the drugs and different treatments depending on the individual. He used the principle that the body produced symptoms as a defense against disease and could be taught to heal. Hahnemann created the slogan "let likes be cured with likes." For example, stinging nettle became the homeopathic remedy for itchy hives.
Homeopathic products were prolific and popular in England throughout the 1900s. Homeopathic doctors have treated the royal family since the 1930s. In America, medicine actually began with homeopathy. The first national medical association in the United States was the American Institute of Homeopathy, founded in 1844. By 1900, 20 percent to 25 percent of all physicians in urban areas called themselves homeopaths. Twenty-two homeopathic medical schools helped staff more than 100 homeopathic hospitals, some treating such well-known people as John D. Rockefeller and Daniel Webster. However, after 1900, homeopathy suffered a rapid decline until, decades later, few people aside from health professionals even knew the word. The main opponent to homeopathy (and to midwifery) was the American Medical Association, which eventually influenced legislation that limited both homeopathic training and its practice.
Until recently, U.S. homeopathic drugs were marketed on a limited scale by a few manufacturers who had been in business for many years and had predominantly served the product needs of a small number of licensed practitioners. For that reason, homeopathic drug containers historically have included little or no labeling for the consumer. However, today's homeopathic drug market has grown into a multimillion-dollar industry in the United States, with a significant increase in both the importation and domestic marketing of homeopathic drug products. Although licensed practitioners must dispense homeopathics to treat serious disease conditions, homeopathic remedies for common ailments have become readily available.
Susan D. Brienza is an attorney in the Denver office of the national, Washington, D. C.-based law firm Patton Boggs LLP. She specializes in regulatory compliance, food and drug law (including DSHEA) and FTC law. If you have a question, her e-mail address is [email protected]
This column is not meant, and should not be construed, as a legal opinion, or legal advice, but rather is intended to provide general principles and some examples as to various aspects of FDA law.
Natural Foods Merchandiser volume XXIII/number 7/p. 38-39