…but we can’t afford to back off — we need to keep up the pressure. Action Alert!
Have you – or any of your loved ones been using or relying on homeopathic products for your health? Do you think we should have the right to use them because they’ve been shown to be both safe and efficacious over many decades?
Bottom line: the FDA wants to see all homeopathics banned, its prejudice against homeopathy having changed little since the publication of the Flexner Report in 1910. It is only grassroots and congressional pressure that has stopped bans in the past. That’s why can’t afford to take our eye off the homeopathic ball for one minute!
You’ll recall we’ve told you before how the FDA issued guidance in December 2022 declaring that all homeopathic medicines are on the market illegally. We’ve been working alongside our allies to protect access to these medicines and to get the FDA to back off, and we have some amazing news: the Senate Appropriations Committee included language aimed at protecting homeopathy in their report accompanying the annual FDA spending bill. This is a clear message to the FDA that Congress is aware of the FDA’s attack and wants the agency to work to ensure a legal pathway for homeopathic medicines to be marketed in the US.
The Senate report language asks the FDA to implement “a legal pathway that includes homeopathic specific standards for the regulation of these medicines” and to work with the homeopathic community to ensure continued access to homeopathic medicines. The Senate Appropriations Committee adds that the FDA’s “interpretation of the law that all homeopathic medicines are unapproved new drugs that are illegally marketed has created confusion both for the homeopathic community and enforcement officials.”
This is a testament to the fact that your advocacy is working. This report language mirrors many of the points we’ve been making about the FDA’s conduct towards homeopathy. It is a huge win and shows that Congress is finally starting to come around on this issue.
You can review our previous coverage for all of the details regarding the FDA’s threat to homeopathy. In issuing its new policy towards homeopathic medicines, the FDA is trying to assert the power to remove any homeopathic medicine it wants to, whenever it wants to. That’s because, technically speaking, the agency has declared that no homeopathic medicines are legally on the market. In effect, the current law hands the FDA a loaded gun it can use at its discretion.
The FDA says it plans to prioritize going after certain products: 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. But make no mistake, this new policy is a threat to all homeopathic medicines. The FDA’s guidance clearly indicates that, in the agency’s view, all homeopathic medicines are technically on the market illegally because they haven’t gone through the new drug approval process nor been generally recognized as safe and effective (GRAS/E).
We need to build on this momentum! Alongside our allies, we’re working to get an amendment added to a House appropriations bill preventing the FDA from attacking homeopathic medicines that meet existing safety and manufacturing standards—but we need grassroots support to get it across the finish line.
The appropriations language we’re supporting would prevent the FDA from removing homeopathic medicines simply because they haven’t been recognized as GRAS/E or approved as new drugs—an impossible standard for homeopathic medicines since many of them are hundreds of years old and not patentable like new-to-nature drugs are. The huge investment it takes to get a product through FDA approval cannot generally be recouped in the case of homeopathy. This is a part of a very slippery slope for what’s already happened in Europe, where no homeopathic products have been able to navigate the registration system. The attack in homeopathy’s birthplace – Germany – is now at fever pitch, with medical doctors, traditionally the most important prescribers of homeopathics, having recently been banned from prescribing them. The new language we’re supporting would allow the FDA to pursue enforcement actions only against products that actually violate existing manufacturing and labeling standards for drugs while protecting access to homeopathic medicines that are in compliance.
Like the unfounded attacks against dietary supplements for being unregulated and unsafe (see this week’s companion article), the FDA’s focus on homeopathic medicines is another example of a problem in search of a solution. Homeopathic medicines are incredibly safe. A review of the evidence of adverse events related to homeopathy, which included data from 12 European countries, the US, Mexico, India, Israel and Brazil published 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. Worldwide, an estimated 200 million people use homeopathy regularly, including 6 million in the United States. By comparison, foodborne illness contributes to on average of 128,000 hospitalizations and 3,000 deaths annually in the US alone. These data show that adverse events from homeopathic medicines occur at a very, very low rate. So what is exactly is the public health issue the FDA is trying to solve?
Notice, too, how the FDA and other homeopathy critics want to have it both ways. Homeopathy is snake oil and too diluted to have any medicinal effect, but it’s also dangerous.
As a refresher for those unfamiliar with homeopathy: the foundational principle of homeopathic medicine is the “principle of similars.” This refers to a drug’s power to elicit a healing response when given in extremely diluted doses to people who exhibit symptoms similar to the medicine’s toxicology. In homeopathy, a medicinal substance is typically chosen for its ability to mimic the symptoms the sick person is experiencing. For example, when you chop a red onion, it causes watery eyes and a runny nose in most people. Allium cepa is a remedy created from red onion; in infinitesimal doses, Allium cepa is intended to activate the body’s own mechanism for stopping watery eyes and a runny nose. The most likely mechanism appears to be linked to the ability of an energetic signal being transferred to the body and its energy field via the homeopathic dilution, rather than it being a direct pharmacological effect caused by an active ingredient. The lack of understanding of the mechanism is one reason why prejudices are so commonplace among those still wedded to the allopathic, pharmaceutical model.
While most homeopathic medicines aren’t going to disappear overnight, we do believe that, slowly but surely, the agency will target and eliminate the homeopathic medicines that compete with FDA approved drugs because the fees companies pay for drug approval fund a substantial portion of the FDA’s operations. Homeopathic medicines are popular for allergies, for example, and this cuts into the market for drugs: the market for antihistamine nasal sprays is just under $2 billion; the market for Zyrtec, one of the most popular antihistamine drugs, was valued at $1.675 billion in 2021. 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. The FDA has already started this process, targeting injectable homeopathic medicines first.
We need to communicate to Congress that voters care about access to homeopathy and other natural medicines. A national survey found that 70% of Americans are more likely to support Congressional candidates who will protect access to supplements and homeopathic and other natural remedies.
Action Alert! Write to Congress in support of appropriations language that prevents the FDA from attacking safe homeopathic products that comply with existing safety and manufacturing standards. Please send your message immediately.