Medical

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

FDA to crack down on "harmful,...
The FDA has set its sights on homeopathic medicine in a new push to control this unproven, yet massive, alternative medicine industry
The FDA has set its sights on homeopathic medicine in a new push to control this unproven, yet massive, alternative medicine industry
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The FDA has set its sights on homeopathic medicine in a new push to control this unproven, yet massive, alternative medicine industry
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The FDA has set its sights on homeopathic medicine in a new push to control this unproven, yet massive, alternative medicine industry

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

14 comments
JimFox
Homeopathy has been, as stated, totally discredited. A ban is necessary.
Nik
While Homeopathy is undoubtedly quackery, as it is based on an unproven assumption, my concern is that this may be the thin end of a long wedge by the 'Big Pharma' industry to eliminate competition from herbal remedies. They have already succeeded with marijuana, and in some places, like France, with St Johns Wort, both long standing, historical remedies. In the UK, 'Doctors' managed to eliminate the herbal practitioners in the past, by having them declared as witches, and then burnt to death, and so losing a wealth of valuable remedies. A UK television program, that researched various skeletons from history, found one that had been treated for horrendous battle wounds, where the victim had not only survived, but had continued to live into old age, for those times, whereas even today his survival would be doubtful. Chinese or other herbal remedies have been shown to be successful in treating ailments where 'Big Pharma's' synthetic products have failed to be effective, or have caused more problems than they have cured. I can testify to that experience. There is a tendency for people to forget that over 70% of 'modern' medicines are based on herbal remedies, and are often inferior, due to unwelcome side effects, not experienced by the original remedies, as the synthetic products are not identical to the original, having been simplified to make it easier to manufacture, and therefore increase profits. In addition, there are researchers scouring the Amazon, and other areas for new herbal remedies for big pharma to synthesise, which confirms the efficacy of herbal products.
andy68
The FDA has a history of eliminating any challenges to the business interests of Big-Pharma. According to the official line, homoeopathy cannot possibly have any effect, so, logically, it cannot possibly do any harm. It is an infringement of civil-liberties to prevent people from using the medical systems they chose, unless a system can be shown to be causing harm.
tsvieps
If it is not harmful, please let me decide if it is useful to me. Stop protecting me. I am a grownup.
This is the same agency that decided walnuts had to be treated as a medicine because a walnuts company had links on its website to scientific articles that discussed the health benefits of walnuts.
akarp
"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."
Too bad this isn't the case with Big-Pharma and calims that opiods are not additictive.
matt43
Oh big surprise, yet another liberal-filled FDA granny Government crackdown on the opponents a gigantic corporate interest group, and grabbing further power "reserved to the States or to the people" by our Constitution.
EZ
I recall watching a video of a former head of the FDA (woman) saying the agency was totally controlled by the oil-based drug cartel and that it needed to be held accountable. Looks like she didn't have much influence. She also said that over half of the FDA's budget came from profits made by the big and slimy drub companies. Personally, I have found some natural substances work better for some things that the modern "miracle" drug company products. Haven't found one yet for my restless leg syndrome though.
Signmaster
I agree with most all said here; I think the key is Million Dollar... they want their cut. Also it said "over 400 adverse events reported and up to 10 deaths potentially related to this homeopathic remedy." Potentially?!?! Really? When drugs get approved without fully testing, cause multiple deaths, then the FDA passes legislation protecting the drug co. from being sued; yup, good 'ol boys in action; protect the money, not the public as you were created to do...
Craig Jennings
I wonder how they account for the 100k deaths in the US alone from prescription medication.... They seem to be harping on about the "harm" and trot out 10 "potential deaths" (may their baby souls rest in peace :() If they just tightened advertising rules then they'd get rid of all the "may" "could" and.... "potential". Either it works or it don't, show the working :)
Kevinb
The FDA is totally trustworthy - opium for everyone!