Senators Mike Lee (R-UT) and Tommy Tuberville (R- AL) have recently introduced a bill that would limit the FDA’s ability to regulate the blatant pseudoscience of homeopathy. This is how they frame it: “The Homeopathic Drug Product Safety, Quality, and Transparency Act will provide a pathway for homeopathic medicinal products to be lawfully marketed by the Food and Drug Administration without needlessly banning safe products that simply do not fit into the same legal categories as traditional pharmaceuticals.”
They are promoting this bit of malfeasance with the usual tropes:
“Americans have a right to manage their own health and choose treatments that are right for them, including homeopathic methods,” said Senator Mike Lee. “The current federal regulatory framework is designed around traditional pharmaceuticals, but it is ill-equipped to review the safety and effectiveness of homeopathic products.
“I’ve long been an advocate for homeopathic medicine,” said Senator Tommy Tuberville. “The reality is that too many Americans today are hooked on pharmaceuticals when they could be using homeopathic remedies, which are often cheaper and can yield miraculous results.”
[H]omeopathy has been clinically studied – and unsurprisingly, it doesn’t work. To put it more technically, there is insufficient evidence to reject the null hypothesis that homeopathic products have no specific efficacy or any effect beyond placebo for any indication. Multiple independent systematic reviews have come to this basic conclusion. Magic, it turns out, isn’t real.
Selling a product to the public that demonstrably does not work with claims that it does work is, quite simply, fraud. So why is this allowed at all? Partly because of a US Senator who was a homeopath, Royal S. Copeland (D-NY), who is responsible for creating the current framework in which the FDA regulates homeopathic products. … The FDA decided that homeopathy was too small a market to waste their limited resources on so they just accepted the homeopathic pharmacopoeia as a list of approved products – no evidence required.
However, in 2019 the FDA reviewed its regulation of homeopathy because of the growing industry, and they did strengthen their regulations (although not nearly enough). Mainly they required greater scrutiny of manufacturing for safety and quality concerns, while still ignoring the complete lack of any effectiveness. Meanwhile the FTC changed its regulations requiring more transparency in labeling – again, good but not far enough.
Now it seem that Tuberville and Lee are not happy with the FDA partly doing its job, so they want to stop them. Mike Lee is from Utah, which is the epicenter of the alternative health product industry in the US, so he is likely just serving this industry in his state (as Orrin Hatch did before him).
…
Share this article
Saying that consumers have a right to make their own choices is grossly misleading. It’s like saying they should be able to drive over whatever bridge they want, or consume tainted meat, employ incompetent doctors and car mechanics, or endure unsafe work conditions. It’s nearly impossible for individual people to determine if a medicine is safe and effective from their own anecdotal use. Safety is often a matter of statistics from systematic reviews of many cases, as is efficacy.
…
So we appear to have an industry shill and a true believer trying to weaken the FDA’s ability to protect the public from clearly fraudulent and worthless products. Further, MAHA sycophants are lining up behind them.
Steven Novella is a neurologist, science writer, and the host of the Skeptics Guide to the Universe podcast. Find Steven on X @stevennovella
This is an excerpt of an article originally posted at Science-Based Medicine and is reposted here with permission. Any reposting should credit both the GLP and original article.
