The agency is doubling down on a bad guidance that endangers access to important medicines. Action Alert!
Recently, the FDA announced the withdrawal of Compliance Policy Guide 400.400, a document that had been in place since 1988 and which established the agency’s enforcement policies regarding homeopathic medicines. In its place, the FDA has issued a revised draft guidance declaring all homeopathic drugs are being marketed illegally. We must fight back against this attack on homeopathic medicine.
As we’ve reported previously, the FDA’s guidance says:
- Any homeopathic drug that has not been considered “generally recognized as safe and effective” (GRAS/E) is considered a new drug;
- FDA has not determined that any homeopathic drugs are GRAS/E;
- A new drug cannot be marketed unless it goes through the FDA’s approval process;
- No homeopathic drugs have gone through FDA approval nor can any producer afford to take them through the approval process.
This means, according to the FDA, all homeopathic medicines are being marketed illegally. The FDA explains that it will focus enforcement actions against specific categories of medicines with safety concerns: products with dangerous ingredients, products intended for vulnerable populations, etc. However, the FDA does reserve the right to take action against any homeopathic product: “This guidance is intended to provide notice that any homeopathic drug product that is being marketed illegally is subject to FDA enforcement action at any time.”
There is not much new in the revised guidance. The FDA does provide a definition of “homeopathic drug,” which was notably absent from the initial guidance, much to the confusion of the homeopathic industry and other stakeholders.
It is somewhat encouraging that the agency did not issue a final guidance, but rather another draft. This is an indication that our voices are being heard and the FDA is engaging with the natural health community.
There seems to be a lot of confusion about homeopathy. While opponents often say that there is not any evidence that homeopathy works, in fact several major meta-analyses have found homeopathic medicines to have an effect greater than placebo. We address these and some other common misconceptions here.
Unfortunately, it’s likely that the FDA’s antipathy towards homeopathy is fueled more by a desire to protect drug industry profits than ignorance about the data. The FDA continues to cite homeopathic teething tablets with belladonna as one of the concerns that prompted the agency to tighten control over homeopathic medicines. Specifically, the agency states that 99 adverse events were “possibly related” to homeopathic teething products. Yet, while the agency did find variable amounts of belladonna in some products, these amounts were well within safe limits, even if an infant swallowed an entire bottle.
The FDA will not stop this attack on homeopathy unless it is forced to do so by engaged citizens. We must issue a strong response to the FDA and Congress, telling the government that these actions threaten the future of homeopathic medicine.
Action Alert! Write to the FDA and Congress, telling them to protect consumer access to homeopathic medicines. Please send your message immediately.