The FDA is taking another step forward in its plans to eliminate homeopathic medicines from the market. Action Alert!
The FDA submitted its terrible draft guidance that threatens consumer access to homeopathic medicines to the Office of Management and Budget (OMB), a clear sign that the agency intends to make its policy final. We’re running out of time to stop the FDA from eliminating thousands of homeopathic medicines—we have to step up the pressure!
The wheels of government bureaucracy are notorious for moving incredibly slowly—except, apparently, when eliminating natural medicines is on the docket.
The OMB’s Office of Information and Regulatory Affairs (OIRA) reviews significant regulations to ensure that there has been an appropriate consideration of costs and benefits and that the agency issuing the rule has made a “reasoned determination that the benefits justify the costs.” Unsurprisingly, OIRA concluded on November 28th, just eleven days after receiving the guidance from the FDA, that no changes are needed to the guidance—meaning the FDA can move forward with issuing a final version.
The stakes couldn’t be higher. As we reported when the draft guidance was initially released in 2017, the FDA essentially says that all homeopathic medicines are illegal. For those who don’t remember, in the guidance, the FDA 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.
In one fell swoop, the FDA declared that virtually every single homeopathic drug on the market is being sold illegally. The guidance explains that the agency will apply a risk-based regulatory approach, but these are meaningless words—the agency can attack, and has attacked, any medicine it chooses.
For example, in 2020, the agency attacked companies selling injectable homeopathic products because, in the agency’s view, injectable homeopathic medicines “can pose a serious risk to patient health.” One of the products the FDA targeted was Traumeel, a prescription-only injectable homeopathic medicine for pain (the cream form of Traumeel is still available). According to the manufacturer, out of more than 200 million ampules sold, there have been 154 adverse reactions, including 7 serious adverse events. Traumeel is an alternative to opioids, which in 2019 alone killed 50,000 Americans.
The truth is that homeopathic medicines are overwhelmingly safe. One review of safety data from 17 countries between 1978 and 2010 found a total of just 1,159 adverse events. This equates to an average of just over 50 cases per annum across all 17 countries from which studies were conducted. Contrast this record of safety for homeopathic medicines with adverse events from FDA-approved drugs. From 1978 to 2010, there were more than 3.5 million serious adverse events and 571,398 deaths, according to the FDA’s database.
Homeopathic drugs were intended to be grandfathered when the Food, Drug, and Cosmetic Act came into being, and this is being ignored by the agency. The FTC has also targeted homeopathy, declaring that an over-the-counter homeopathic drug claim that is not substantiated by “competent and reliable” scientific evidence (read: hugely expensive drug trials) is considered deceptive if it doesn’t include the following disclaimer: 1) there is no scientific evidence that the product works; and 2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.
Why is the FDA focusing on homeopathic medicines that are far safer than the pharmaceutical drugs they approve? We can infer some answers. The FDA gets a large part of its funding from drug company user fees, and for this reason sees Big Pharma as its client. Homeopathic medicines, like supplements and other natural products, compete with pharmaceutical drugs, so the FDA uses its enormous power to tilt the scales in favor of the drug companies. And because natural products and homeopathic medicines generally cannot be patent-protected like drugs can, they can’t afford FDA-approval and so the health claims they can make are severely restricted. It is one among many ways cronyism is undermining healthcare in this country.
Action Alert! Write to Congress and the FDA, urging them to take immediate action to ensure that Americans can continue to access homeopathic medicines. Please send your message immediately.