This is the beginning of the end for homeopathy unless we do something about it. The FDA has completed their overhaul of homeopathy regulation, and it is as we feared: in the FDA’s view, all homeopathic products are illegal. This interpretation gives the agency the power to remove any homeopathic medicine it wants to, whenever it wants to. We must convey consumer outrage to Congress and the FDA if we want to save homeopathy.
Homeopathic drugs will not all disappear overnight. The FDA will probably adopt a similar playbook as the one they’re using to eliminate compounded medications, employing a strategy of “death by a thousand cuts.” Slowly but surely the agency will target and eliminate homeopathic medicines one by one until it is impossible for companies to stay in business. Clearing the market in one fell swoop would create headlines; picking off medicines one by one over time allows the agency to accomplish the same goal without drawing as much attention or generating as much outrage.
Why is the FDA doing this? The agency, in attacking homeopathy, is working, once again, to protect the bottom line of drug-makers. One of the most popular uses for homeopathic medicines is for allergies. But consider that the market for Zyrtec, one of the most popular antihistamine drugs, was valued at $1.675 billion in 2021; the market for antihistamine nasal sprays is just under $2 billion. The same applies to other conditions. There’s good evidence, for example, to suggest homeopathy is effective for rheumatoid arthritis and pain management. The market for rheumatoid arthritis drugs and pain management drugs is $60 billion and $73 billion, respectively. Homeopathy cuts into these massive profits. Big Pharma and the FDA, which gets its funding from Big Pharma, want to eliminate this competition.
The FDA says it will focus on a few product categories for enforcement: those with safety concerns, products with routes of administration other than oral or topical, products to treat “serious or life-threatening conditions,” products for vulnerable populations, and products with “significant” quality issues.
We noted previously that the agency went after injectable homeopathic medicines. This means that homeopathic mistletoe for injection is on the chopping block, a safe cancer therapy that has been used for years. Studies show that mistletoe can improve symptoms and quality of life, and reduce chemotherapy and radiotherapy side effects, including in pancreatic, lung, colorectal, and breast cancers.
OTC homeopathic medicines for cold and flu, teething, allergies, and other less serious conditions that can resolve spontaneously with or without treatment are likely safe for the time being. But the FDA also notes unequivocally that, although they outline a risk-based approach, no homeopathic medicines are safe.
The agency states: “However, 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 [emphasis added].”
Earlier this month, we reported that the FDA was preparing to release the final version of their terrible guidance document setting forth the agency’s approach to regulating homeopathic drugs. Substantively, the final version is unchanged from the draft. The guidance declares that all homeopathic drugs are illegal because:
1. Any homeopathic drug that has not been considered “generally recognized as safe and effective” (GRAS/E) is considered a new drug;
2. FDA has not determined that any homeopathic drugs are GRAS/E;
3. A new drug cannot be marketed unless it goes through the FDA’s approval process;
4. No homeopathic drugs have gone through FDA approval.
The FDA is, and has been, out of control. It approves dangerous, expensive drugs that don’t work, and works to eliminate your access to natural alternatives to those dangerous, ineffective, and expensive drugs. The FDA doesn’t even want you learning about the benefits of natural products, lest you are persuaded to opt for medicines that are not FDA-approved drugs.
Homeopathy is used by almost 7 million Americans, who the FDA apparently thinks are not equipped to make their own healthcare choices.
We need to register consumer outrage by flooding the public docket with comments demanding that access to homeopathic products—which are overwhelmingly safe—be retained.