Homeopathy: Real Medicine?

by Food and Drug Administration (FDA)

Some of the medicines of homeopathy evoke positive images — chamomile, marigold, daisy, onion. But even some of Mother Nature's cruelest creations — poison ivy, mercury, arsenic, pit viper venom, hemlock — are part of homeopathic care.

Homeopathy is a medical theory and practice that developed in reaction to the bloodletting, blistering, purging, and other harsh procedures of conventional medicine as it was practiced more than 200 years ago. Remedies made from many sources — including plants, minerals or animals — are prescribed based on both a person's symptoms and personality. Patients receiving homeopathic care frequently feel worse before they get better because homeopathic medicines often stimulate, rather than suppress, symptoms. This seeming reversal of logic is a relevant part of homeopathy because symptoms are viewed as the body's effort to restore health.

The Food and Drug Administration regulates homeopathic remedies under provisions of the Food, Drug, and Cosmetic Act.

Kinder, Gentler Medicine

In the late 1700s, the most popular therapy for most ailments was bloodletting. Some doctors had so much faith in bleeding that they were willing to remove up to four-fifths of the patient's blood. Other therapies of choice included blistering — placing caustic or hot substances on the skin to draw out infections — and administering dangerous chemicals to induce vomiting or purge the bowels. Massive doses of a mercury-containing drug called calomel cleansed the bowels, but at the same time caused teeth to loosen, hair to fall out, and other symptoms of acute mercury poisoning.

Samuel Hahnemann, a German physician disenchanted with these methods, began to develop a theory based on three principles: the law of similars, the minimum dose, and the single remedy.

The word homeopathy is derived from the Greek words for like (homoios) and suffering (pathos). With the law of similars, Hahnemann theorized that if a large amount of a substance causes certain symptoms in a healthy person, smaller amounts of the same substance can treat those symptoms in someone who is ill. The basis of his theory took shape after a strong dose of the malaria treatment quinine caused his healthy body to develop symptoms similar to ones caused by the disease. He continued to test his theory on himself as well as family and friends with different herbs, minerals and other substances. He called these experiments "provings."

But, as might be expected, the intensity of the symptoms caused by the original proving was harrowing. So Hahnemann began decreasing the doses to see how little of a substance could still produce signs of healing.

With the minimum dose, or law of infinitesimals, Hahnemann believed that a substance's strength and effectiveness increased the more it was diluted. Minuscule doses were prepared by repeatedly diluting the active ingredient by factors of 10. A "6X" preparation (the X is the Roman numeral for 10) is a 1-to-10 dilution repeated six times, leaving the active ingredient as one part per million. Essential to the process of increasing potency while decreasing the actual amount of the active ingredient is vigorous shaking after each dilution.

Some homeopathic remedies are so dilute, no molecules of the healing substance remain. Even with sophisticated technology now available, analytical chemists may find it difficult or impossible to identify any active ingredient. But the homeopathic belief is that the substance has left its imprint or a spirit-like essence that stimulates the body to heal itself.

Finally, a homeopathic physician generally prescribes only a single remedy to cover all symptoms — mental as well as physical — the patient is experiencing. However, the use of multi-ingredient remedies is recognized as part of homeopathic practice.

FDA Regulation

In 1938, Sen. Royal Copeland of New York, the chief sponsor of the Food, Drug, and Cosmetic Act and a homeopathic physician, wrote into the law a recognition of any product listed in the Homeopathic Pharmacopeia of the United States. The Homeopathic Pharmacopeia includes a compilation of standards for source, composition and preparation of homeopathic drugs.

FDA regulates homeopathic drugs in several significantly different ways from other drugs. Manufacturers of homeopathic drugs are deferred from submitting new drug applications to FDA. Their products are exempt from good manufacturing practice requirements related to expiration dating and from finished product testing for identity and strength. Homeopathic drugs in solid oral dosage form must have an imprint that identifies the manufacturer and indicates that the drug is homeopathic. The imprint on conventional products, unless specifically exempt, must identify the active ingredient and dosage strength as well as the manufacturer.

"The reasoning behind [the difference] is that homeopathic products contain little or no active ingredients," explains Edward Miracco, a consumer safety officer with FDA's Center for Drug Evaluation and Research. "From a toxicity, poison-control standpoint, [the active ingredient and strength] was deemed to be unnecessary."

Another difference involves alcohol. Conventional drugs for adults can contain no more than 10 percent alcohol, and the amount is even less for children's medications. But some homeopathic products contain much higher amounts because the agency has temporarily exempted these products from the alcohol limit rules.

"Alcohol is an integral part of many homeopathic products," says Miracco. For this reason, the agency has decided to delay its decision concerning alcohol in homeopathic products while it reviews the necessity of high levels of alcohol.

"Overall, the disparate treatment has been primarily based on the uniqueness of homeopathic products, the lack of any real concern over their safety because they have little or no pharmacologically active ingredients, and because of agency resources and priorities," explains Miracco.

However, homeopathic products are not exempt from all FDA regulations. If a homeopathic drug claims to treat a serious disease such as cancer it can be sold by prescription only. Only products sold for so-called self-limiting conditions — colds, headaches, and other minor health problems that eventually go away on their own — can be sold without a prescription (over-the-counter).

Requirements for nonprescription labeling include:

• an ingredients list
• instructions for safe use
• at least one major indication
• dilution (for example 2X for one part per hundred, 3X for one part per thousand).

About the Author

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