FDA to crack down on "harmful, unproven homeopathic drugs"

It hasn't been a great year for advocates of homeopathy – a pseudoscience that has been practiced for over 200 years. Following on from authorities in the European Union, United Kingdom and Australia cracking down on homeopathic treatments, the FDA is proposing a new "risk-based enforcement approach" promising greater scrutiny of the massive US$3-billion-dollar industry.

While homeopathic drugs should be regulated in the same way as any other drug, the FDA created a special dispensation in 1988 allowing homeopathic drugs to be distributed in the US without regular approval. As times changed so did alternative medicine markets, and the recent FDA announcement now recognizes that what may have been a small fringe community 30 years ago, is now a major billion-dollar industry, and greater oversight could be necessary.

"In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer," says FDA Commissioner Scott Gottlieb. "In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren't adequately tested or disclosed to patients."

The announcement is most certainly spurred on by the discovery in late 2016 of dangerous levels of a toxic substance called belladonna in a brand of homeopathic teething tablets. In the years leading up to this product's ultimate discontinuation there were over 400 adverse events reported and up to 10 deaths potentially related to this homeopathic remedy.

The Federal Trade Commission (FTC) is also turning its sights on homeopathy, announcing in late 2016 that any health-related claims made by a product must be backed up by scientific evidence. The FTC claims it will be increasing scrutiny into homeopathic marketing that doesn't clearly add the disclaimer that any health benefits, "are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts."

Over the last 12 months, several regulatory bodies around the world have turned their focus on the field of homeopathy. In September, the European Academies Science Advisory Council (EASAC) released an expansive set of recommendations suggesting that public health bodies in the European Union should not reimburse homeopathic products.

EASAC cites numerous studies suggesting not only has homeopathy been effectively discredited time and time again, but that the field also presents dangers to patients by potentially delaying more robust and proven medical treatments. The advisory council sharply concluded its report quoting an influential study from 1998 on the risks of untested and unregulated medicines: "There cannot be two kinds of medicine – conventional and alternative. There is only medicine that has been adequately tested and medicine that has not …"

Both Australia and the United Kingdom also set out to scrap any public subsidies for homeopathic treatments in 2017. The chief executive of the National Health Service England described homeopathy as, "at best a placebo and a misuse of scarce NHS funds."

Despite 2017 at times feeling like a year where an anti-science sentiment was stridently taking hold, it is good to know that common sense can still prevail, and while those who choose to treat water as medicine are still entirely free to do so, it's reassuring that governments and public health bodies are not supporting the large-scale spread of misinformation.

Source: FDA