The FDA wants to up-end the homeopathic industry—because it’s become too popular. Help us stop this insanity! The FDA has tossed out the guidance that previously governed homoeopathy and has proposed a new framework that threatens the entire industry.
Long-time natural health champion Senator Orrin Hatch (R-UT) and Rep. Ryan Costello (R-PA) are spearheading efforts in Congress to correct this overreach. They are preparing sign-on letters which argue that the FDA should not completely withdraw the previous regulatory framework (Compliance Policy Guide 400.400) for homeopathic products.
A few weeks ago, we told you about the FDA’s latest action against homeopathic products. The agency’s new position is technically that every homeopathic product on the market is being sold illegally because 1) no homeopathic drug has been determined to be generally recognized as safe and effective (which is required for a drug to be sold over-the-counter) and 2) no homeopathic drug has gone through the FDA’s new drug approval process.
With the FDA’s new guidance, homeopathic products will be subject to the same rules as other over-the-counter drugs or new drugs—a move that could eliminate many homeopathic products from the market. New drug approval for homeopathic products is burdensome, duplicative, and inappropriate.
The Homeopathic Pharmacopeia of the United States (HPUS) establishes standards for homeopathic products to follow. An ingredient’s inclusion in HPUS means that it has been determined to be safe and effective by the Homeopathic Pharmacopeia Convention of the US.
In essence then, homeopathic products have undergone premarket reviews for safety and effectiveness; requiring further review, or expensive testing to confirm safety and effectiveness, is unnecessary and would impose tremendous regulatory costs on the homeopathic industry.
Others have also pointed out that this is in fact a higher regulatory threshold than that applied to allopathic over-the-counter (OTC) drugs, since many OTC drugs can be sold as long as they comply with an FDA OTC monograph.
The FDA excluded homeopathic drugs from the new drug approval process and the over-the-counter review process for decades because they were viewed, appropriately, as a separate category of medicine. The reason for the FDA’s change of heart is the growth of the homeopathic industry—growth which no doubt threatens the bottom line of the drug manufacturers that work closely with the FDA.
Since 1988, Compliance Policy Guide 400.400 has served as the FDA’s blueprint for the regulation of homeopathy. It clearly defines homeopathic drugs as “any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States,” and it appropriately exempts homeopathic products from certain rules and regulations that apply to pharmaceutical drugs. This policy covers labeling requirements for homeopathic products and states that the FDA will focus enforcement actions against companies who fail to comply with 400.400.
Compliance Policy Guide 400.400 worked. Homeopathic drugs manufactured in conformance with the HPUS and current good manufacturing practice do not pose a public health risk; nothing is safer than homeopathic preparations. A World Health Organization report on homeopathic products concluded that “Adverse events occurring during homeopathic treatment are rarely attributed to the homeopathic medicine itself.”
Considering the myriad public health problems facing this country, including the opioid epidemic and the overuse of antibiotics, it is ludicrous that the agency is focusing on homeopathic drugs. Could it be that, like supplements, homeopathic drugs compete with pharmaceutical drugs? Recall, too, that the FDA has announced that they are targeting alternatives to opioids in the midst of an epidemic of opioid addiction that is killing 115 Americans every day.
We must encourage our senators and representatives to sign on to the Hatch and Costello letters and send a clear message to the FDA: the previous regulatory policy was sufficient to ensure consumer access to safe homeopathic remedies, and we don’t need to fix what isn’t broken.
Action Alert! Write to your elected officials and urge them to support reigning in FDA overreach in regulating homeopathic products. Please send your message immediately.