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The FDA and Homeopathy: Can the Agency Bring Medicine Out of the 1700s?

Although the FDA has jurisdiction over homeopathic products, it has to date essentially given homeopathic drugs a pass, and has not required them to demonstrate they are safe and effective. Why is that?
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Let's say you have a bad cold. You look for something to help you with the symptoms, stopping by your local drugstore or perhaps browsing online. There are many brands to choose from. You see something that promises gentle and natural relief from cough and congestion, with no side effects. Wow. That sounds good. Plus the website for the product states that the product is regulated by the Food and Drug Administration (FDA), so it has to be safe and effective, correct?


You happened to pick a homeopathic product. And although the FDA has jurisdiction over homeopathic products, it has to date essentially given homeopathic drugs a pass, and has not required them to demonstrate they are safe and effective.

Why is that? It's a complicated history, but here's a short explanation, along with a primer on the pseudoscience of homeopathy.


The late 1700s was not exactly a high watermark for the practice of medicine. Many physicians still thought that diseases were caused by an imbalance of humors, and bloodletting was a popular remedy. This was decades before scientists such as Robert Koch first discovered microorganisms and the connection between these microorganisms and disease.

It was in this prescientific era that Samuel Hahnemann developed homeopathy, based on two principles. One principle is the law of similars, which claims that medications should produce symptoms similar to the diseases they are trying to cure ("likes cure likes"). The second principle is the law of infinitesimal doses, pursuant to which the more dilute a drug, the more powerful its effect. The first principle is, at best, a wildly inaccurate misstatement of the mechanisms of our immune system. The second principle is flatly contrary to the laws of biology, chemistry, and physics.

Homeopathic drugs are often diluted to such an extent that not even a single molecule of the supposed active ingredient remains in the product. It is impossible -- if we accept modern science -- for the "active" ingredients in these drugs to have any effect. In fact, most homeopathic products, if they are properly manufactured, are essentially inert, which helps explain why the FDA has ignored them (more on that below).

Occasionally, you will hear defenders of homeopathy claim that homeopathy works the same way as vaccines. False. Vaccines contain measurable amounts of antigen molecules, which stimulate the immune system to produce antibodies to specific diseases. No homeopathic drug has been shown to stimulate the immune system to combat a specific disease and, as indicated, the drugs are so diluted their only possible stimulation is to the purses of homeopathic manufacturers.

A recent exhaustive study by the Australian National Health and Medical Research Council (NHMRC), which assessed more than 1,800 papers on homeopathy, reached this unambiguous conclusion:

The review found no good quality, well-designed studies with enough participants to support the idea that homeopathy works better than a placebo, or causes health improvements equal to those of another treatment.

The FDA's Current Oversight of Homeopathy

Why is it that the FDA has allowed homeopathic drugs to be marketed without proof that they are safe and effective? And how can homeopathic manufacturers claim their drugs are "regulated" by the FDA if in fact they are not required to prove their drugs are safe and effective?

Here are the answers: The 1938 Food, Drug, and Cosmetic Act (FDCA) recognized homeopathic products as drugs, provided they were formulated in accordance with the Homeopathic Pharmacopeia of the United States (HPUS). There were multiple reasons for this official recognition of homeopathic products, including the fact that a key sponsor of the FDCA was Royal Copeland, a homeopathic physician. But government regulators who were not homeopaths also favored this official recognition of a specific category of homeopathic products because at the time they were concerned about charlatans who were peddling alleged homeopathic products that included everything but the proverbial kitchen sink and which were touted as miracle cures for just about anything, including cancer. By limiting homeopathic drugs to those in the HPUS, regulators knew that -- although these drugs were worthless -- they were unlikely to cause serious harm to the public.

Moreover, in 1938, the therapeutic revolution, in which drugs that reliably acted against pathogens were being developed, was just underway. Scientists and government regulators were focused on creating appropriate mechanisms for evaluating drugs which actually did something, which meant they could also have significant side effects. Under these circumstances, homeopathy was regarded as a sideshow, a remnant of 18th century medicine with a limited market that could safely be ignored.

Until this year, the only time the FDA took a hard look at the possibility of requiring homeopathic drugs to prove their effectiveness was in 1972, when the agency briefly considered regulating some homeopathic drugs under its new over-the-counter drug review process. At the end of the day however, the agency decided because of "the uniqueness of homeopathic medicine," efficacy testing would not be required.

So homeopathic manufacturers can currently mislead the public, tiptoeing around outright fraud, because homeopathic drugs are "regulated" in the sense that they are officially recognized as marketable drugs provided they conform to the HPUS (and some minimal labeling requirements the FDA has imposed). But what the manufacturers typically do not disclose is that the FDA has not evaluated these products for safety and effectiveness, unlike the conventional drugs that are sitting right next to them on the drugstore shelf.

The FDA Is Now Reconsidering Its Stance

But the FDA is reconsidering its hands-off approach to homeopathy. It has invited comments on whether its current regulatory framework needs to be modified.

One factor that has finally motivated the FDA to reassess its position is the tremendous growth in the sale of homeopathic products in recent years, now close to $3 billion a year in the United States. The sale of homeopathic drugs is no longer confined to that quaint pharmacy downtown operated by Ma and Pa Hahnemann. Homeopathy is a big business, and homeopathic products are sold by all major retailers. As a consequence, millions of people are purchasing and using products that, at best, do nothing for them (beyond the occasional placebo effect).

What should the FDA do? If the agency were rigorous in its application of science, it would require homeopathic manufacturers to prove, through controlled double-blind drug studies, that their products actually are safe and effective. That probably will not happen, however, because it would result in the virtual end of the sale of homeopathic drugs in the United States and large-scale political fallout.

Nonetheless, what the agency can and should do is mandate that homeopathic products carry a prominent label, highlighted by a bright color or eye-catching design, that clearly states, in large font: "This product has not been evaluated by the FDA for either safety or effectiveness and, therefore, it has not been determined to be safe and effective in preventing or treating any condition or disease." Consumers will then know that the claim that homeopathic drugs are "regulated" by the FDA does not mean they have actually been shown to work.

There will still be people who will buy homeopathic drugs. The level of ignorance among Americans with respect to basic science is appalling, and nowadays marketing anything as "natural" is a surefire way to guarantee some sales. But appropriate labeling will ensure that all consumers have adequate information before their purchase, and it may cause some consumers to think twice about their purchase. Some may even conclude that rather than buy the homeopathic drug, they will just drink a tall glass of water -- it would be equally effective and would save them $15.