The FDA is threatening homeopathy’s future. Here’s how we can save it. Action Alert!
The FDA has proposed a new policy for regulating homeopathy—a policy which is a direct threat to many, many homeopathic medicines. To fully protect consumer access to these treatments, we need Congress to pass a law.
Congress and the FDA have always exempted homeopathy from the same drug requirements as pharmaceutical drugs. Now the FDA, with pressure from big pharmaceutical companies who compete with homeopathic medicine, wants to create an unnecessary policy. As you’ll remember from our previous coverage, the FDA’s new policy states that no homeopathic medicines have been “generally recognized as safe and effective” (GRAS/E) by the FDA or gone through traditional FDA drug approval; therefore technically speaking all homeopathic medicines currently on the market are being sold illegally. However, the FDA said it would prioritize enforcement on products with safety concerns.
Homeopathy has grown into a $3 billion market with increasing demand from consumers looking for alternatives to prescription medicine. If we want continued consumer options for our health we need to send a message to Congress.
In response to the FDA’s new proposal, homeopathy advocates are arguing for a return to the Compliance Policy Guide (CPG) used since 1988. This document, which has provided regulatory guidance for homeopathic remedies, provides a definition for homeopathic drugs, current good manufacturing practices and labeling requirements. Going back to the CPG would help protect our present access but would still leave homeopathic medicine vulnerable to future agency action. Homeopathy should remain permanently exempted from traditional drug standards.
For example, over-the-counter homeopathic medicines are subject to the FDA’s drug review process, which began in 1972 and has since continued. The purpose of this process was to establish that every over-the-counter drug is both safe and effective. At that time, the FDA exempted homeopathic drugs, deciding to review them “as a separate category at a later time after the present over-the-counter drug review is complete” due to the “uniqueness of homeopathic medicine.”
This means that, at any time, the FDA has the power to review homeopathic drugs and is not required by federal statute to treat them differently than other over-the-counter medicines.
Subjecting homeopathy to new drug efficacy requirements would likely eliminate many medicines from the market. Homeopathy has been around since the early 19th century; many of the preparations in the Homeopathic Pharmacopeia—the official compendium of homeopathic monographs and standards—were included based on a history of successful use. This means they can’t be patented now, since they aren’t novel; patents also expire after twenty years, so even if they were patentable when they were first developed, that protection would have ended long ago. Without patent protection, it would be impossible for a company to recoup the astronomical costs of conducting drug trials to prove efficacy, which is required for traditional FDA approval. Forcing efficacy studies for homeopathy would also be duplicative, since the criteria for inclusion in the Homeopathic Pharmacopeia require that a product be safe and effective.
To truly save homeopathy, what is needed is federal legislation that acknowledges homeopathic medicine’s uniqueness and the inapplicability of conventional drug standards. It should provide a definition of homeopathic products, guidelines for manufacturing standards, and recognize the long history of homeopathy’s safe use. This legislation could provide a framework by “grandfathering” homeopathic medicines that have a history of safe use rather than requiring an unnecessary review process. For new homeopathic products, a notification system, recognizing homeopathy’s uniqueness, could be devised.
Why is homeopathy unique? While most medicine is based on drugs—that is, the use of pharmacological agents to treat or suppress the symptoms of a disease—homeopathy is an attempt to prompt the body to cure itself. It is based on the idea of “like treats like.” When you chop a red onion, for example, it causes watery eyes and a runny nose in most people. Allium cepa is a remedy created from red onion; in very small doses, Allium cepa is intended to activate the body’s own mechanism for stopping watery eyes and a runny nose. Homeopathic medicine is often so diluted that the original ingredient is virtually undetectable.
Homeopathy’s distinct nature was recognized by Congress when the Food, Drug, and Cosmetic Act (FDCA) was passed in 1938. Congress defined “drug” in part as a substance recognized in the United States Pharmacopeia (USP), the official Homeopathic Pharmacopeia of the United States (HPUS), or official National Formulary (NF) or any supplement to them. The law, then, did not merge homeopathy with prescription medicines, but recognized them as distinct schools of thought in medical practice. The current proposal is most likely being pushed by big drug companies threatened by the increasing demand for homeopathic medicines that reduces their financial profit.
We need a permanent solution. Federal legislation is the only option that can legally protect homeopathy.
Action Alert! Write to your members of Congress and urge them to champion legislation that would grandfather current homeopathic medicines, while creating a notification system for new products. Please send your message immediately.