MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

Homeopathic remedies are being marketed and sold as though they are medicines, yet highly diluted preparations contain nothing and do nothing. This means consumers are constantly mislead into believing that they are drugs. This situation seems to be changing dramatically in the US, and hopefully – led by the American example – elsewhere as well.

It has been reported that the US Federal Trade Commission issued a statement which said that, in future, homeopathic remedies have to be held to the same standard as other medicinal products. In other words, American companies must now have reliable scientific evidence for health-related claims that their products can treat specific conditions and illnesses.

The ‘Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopathic Drugs’ makes it clear that “the case for efficacy is based solely on traditional homeopathic theories and there are no valid studies using current scientific methods showing the product’s efficacy.”

However, an [over-the-counter] homeopathic drug claim that is not substantiated by competent and reliable scientific evidence might not be deceptive if the advertisement or label where it appears effectively communicates that: 1) there is no scientific evidence that the product works; and 2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts. In other words, if no evidence for efficacy exists, companies must advertise this fact clearly on their labelling, and also disclose that claims are today rejected by the majority of the scientific community. Failure to do this will be considered a violation of the FTC Act.

“This is a real victory for reason, science, and the health of the American people,” said Michael De Dora, public policy director for The Center for Inquiry in a statement issued in response to the new act. “The FTC has made the right decision to hold manufacturers accountable for the absolutely baseless assertions they make about homeopathic products.”

The new regulation will make sure that customers are informed explicitly about whether the product they purchase at a pharmacy has any scientific basis. This is important because homeopathic remedies aren’t just ineffective, but they can be dangerous too. The FDA is currently investigating the deaths of 10 babies who were given homeopathic teething tablets that contained deadly nightshade.

“Consumers can’t help but be confused when snake oil is placed on the same pharmacy shelves as real science-based medicine, and they throw away billions of dollars every year on homeopathy based on its false promises,” said De Dora. “The dangers of homeopathy are very real, for when people choose these deceptive, useless products over proven, effective medicine, they risk their health and the health of their families.”

These are clear words indeed; the new regulation is bound to make a dramatic change for homeopathy in the US. The winner will undoubtedly the consumer who can no longer be so openly and shamelessly misled as before. The FTC has set an example for other national regulators who will hopefully follow suit.

25 Responses to The end of a free ride for homeopathy in the US

  • A little light in the dark Trumpian tunnel of this time. Still, there is a snag. Homeopathy is his kind of business, methinks.

    • You are correct. One of Trumps many cons included selling supplements to the naive. It is about time the FTC began regulating the enormous fraud sold as supplements but the alternative and nutrapharmaceutical lobbies will probably encourage lawmakers to fight this, especially since they have one of their own supporters as soon to be president, who still believes vaccines cause autism.

      • Just as one could make a strong case for increasing the budget of the FDA to enforce the prohibition of disease claims and compliance with cGMPs for dietary supplements, there are those who would lobby against such a change, arguing that increasing the capacity of the FDA would hinder commerce and result in job losses. Among botanical products alone, adulteration is widespread, leaving many consumers to distrust the Industry as a whole. Add the near-impossibility of the FDA adequately policing claims and products on the Internet, and you have a recipe for disaster. When the Dietary Supplement Health and Education (sic) Act was created, commerce on the Internet was practically an afterthought. Yet, there were those in the Industry who predicted that once e-commerce became more widely established, the FDA would a face an impossible task of controlling violations to the Act.

      • I agree. Supplements which are sold within a bogus “treatment paradigm” are almost always unnecessary and a waste of time, money, and potentially a person’s health. I don’t think the supplement business was one of Trump’s best busines ventures. He did make quite a bit of money legally, though.

        • Yes, Trump has made a lot of money unethically and fraudulently! Unfortunately it is not always illegal to lie, cheat and defraud gullible citizens. It is a sad reality of our times.

  • Will this regulation affect advertising as well? I see that Dullman still advertises it as a medicine. I would expect to see all his huffpo articles having the same disclaimer.

  • Unfortunately research on placebos and belief systems seems to indicate the more ridiculous a proposition the more intensely believers hold on to it

  • Good morning MD. Edzard Ernst, we all know that you find this homeopathy. But the evidence is other in the consultations and hospitals of homeopathy. Patients who come with cortisone, immunosuppressants, etc … are cured by homeopathy, I leave here a link of clinical cases: http://hpathy.com/clinical-cases/. This is called evidence-based medicine. Homeopathy is not chemical is physical, then we are talking about different things.

    • I am not sure at all that you understand EBM

    • @Santiago

      What is it about these unverified and unverifiable anecdotes (with titles such as “My vein reminds me of a snake”, ““Wonder Boy” Sneezes 100 Times, Uses Up 100 Tissues!” and “What Remedy Is Marge Simpson?”) that particularly convince you homeopathy works?

    • @Santiago

      Thank you so much for a great laugh.
      I opened the link you gave to that “Hpathy” site and had a look at one of the top cases.
      It tells about a man who came to the homeopath with a large sebaceous cyst in the scalp. Instead of having it removed, which is a very simple operation in local anesthesia and quick recovery the homeopath goes into an absurd “analysis” of symptoms and mental state of the customer and then gives the poor sod sugar pills for more than six months. At last the cyst becomes infected and ruptures as they sometimes do. This the idiot calls a cure and attributes to the sugar pill eating!!!
      I think this “case” describes homeopathy in essence. Homeopathy is the ultimate health-hoax – the AIR GUITAR of medicine if you will.
      It consists of using make-believe medicine to either delay or add to proper treatment and then attributing the outcome to the effects of what in effect is NOTHING.

      I had a look at some of the other “cases” and can confirm that the fools who write this drivel have no clue to anything of medicine, physics or chemistry.
      If you think you can convince someone by having them read this repository of ridiculous anecdotes, then you are either stupid or seriously deluded or both.

  • What is your definition of evidence based medicine for you?

  • Can someone inform Prince Charles of this and document his response?

  • There’s something else to consider…

    In the US, some of the OTC homeopathic remedies that appear on the shelves and on the internet are nothing of the sort. Zicam is the obvious example. That unscrupulous vendors can take advantage of homeopathic remedies being seen in themselves and avoiding safety and efficacy tests does point to deficiencies in the regulatory regime. Some of them make their way abroad.

    Also is worth looking at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074360.htm CPG 400.400 makes it clear that what can be sold as “homeopathic” must be listed in the Homeopathic Pharmacopeia of the United States (HPUS). If it’s not in HPUS, it’s treated as a “new drug” and treated in the way as pharmaceuticals. Yet, there are plenty of them on the US market. Homeopathic hCG is a good example – which the FDA and FTC did act against. The product also ended up in the UK and the MHRA acted.

    The FTC’s announcement is a good first step but it will take more to clean up the mess.

  • EBM should bury 80% of conventional medical practice 😉 Homeopathy is done with and now is the time to get rid of 80% of useless medical ​practice and replace it with true EBM that’s lifestyle medicine! We can and will do it.

  • We should do a big study of the conditions doctors advertise that they can treat successfully and see how much quackery is there. They claim to be able to cure chronic diseases when they just suppress symptoms and cause a multitude of new symptoms that are even worse, called side effects. Something should be done to stop this craziness before too many people are seriously injured. Chronic diseases have lifestyle causes and fall under the domain of lifestyle medicine!

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