We’ve been telling you over the last few years about the recent FDA guidance that threatens the future of homeopathic medicines in the US. Upending decades of safe regulation, FDA released a draft guidance in 2017 that essentially stated that all homeopathic drugs are illegal. ANH-USA, our friends at Americans for Homeopathy Choice, and other stakeholders are working with Representative Ro Khanna (D-CA) to get members of Congress to sign on to a letter to the FDA clarifying how the agency will ensure continued access to important homeopathic medicines. Take action below to urge your member of Congress to support this important initiative!
To recap, the FDA’s guidance document, which lays out the agency’s current position on the regulation of homeopathic drugs, 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.
The guidance also explains that, while all homeopathic drugs are illegal, the FDA will apply a risk-based enforcement approach. The agency has already begun to apply this doctrine; earlier this year the agency attacked manufacturers of injectable homeopathic medicines.
We know this isn’t about safety. 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. These data show that adverse events from homeopathic medicines occur at a very, very low rate.
So why go after homeopathic medicines? 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.