I love to see a regulatory agency actually do its job. Especially within medicine, where it is most important, the lack of political will seems to get in the way of properly regulating health care products and services in the way that most consumers assume they are regulated.
Homeopathy is perhaps the best example. Homeopathy is pure unadulterated pseudoscience and witchcraft. There is no legitimate scientific debate about this. Homeopaths create their potions by starting with fanciful substances that can’t work and then dilute them out of existence. The result is plain water that they claim has magical properties. Yes – that’s really what it is.
Unsurprisingly, rigorous clinical trials have shown that homeopathic potions in fact do not work.
Mainly for historical reasons, the FDA has categorized homeopathic products as drugs. They are not drugs, but that is how they are classified. This means that disease claims can be made for homeopathic products.
For all other drugs regulated by the FDA, the privilege of being able to claim that the drug can treat or cure a specific disease comes with a rather high bar of evidence for safety and efficacy. That seems fair – you can make specific disease claims, but you have to provide sufficienct evidence.
This is in contrast to supplements, for which companies cannot make disease claims. They can only make “structure/function” claims, that the product improves or enhances some structure or function within the body. Diseases cannot be mentioned. Additionally, companies do not need to provide any evidence to back these claims. This is a horrific back door which needs to be closed, but that is a topic for another time.
Homeopathic remedies, however, live in the regulatory netherworld. They have all the privileges of being classified as drugs, but the FDA has unilaterally decided not to enforce the requirement for providing evidence of efficacy. Rather, homeopaths can base claims entirely on their tradition. They can literally just write down a homeopathic potion in their book (the Homeopathic Materia Medica) and make whatever claims they wish. No scientific evidence is required.
Regulations under review
Last year both the FDA (Food and Drug Administration) and FTC (Federal Trade Commission) announced that they were reviewing their current regulation of homeopathic products. Keep in mind this is just about over-the-counter (OTC) products, not the practice of homeopathy by licensed homeopaths or other professionals. That is up to the states.
Both agencies had an open comment period, in which the SfSBM submitted rather strong recommendations. Both agencies have the authority to increase their regulation if they choose. It seems to me that this is purely a matter of political will.
Since the comment periods have closed we have been waiting anxiously for both agencies to announce their decisions. This could be, in the best-case scenario, a death blow to the OTC homeopathy industry.
Yesterday the FTC released their decision. Here is the key part:
The policy statement explains that the FTC will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims. That is, companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions. The statement describes the type of scientific evidence that the Commission requires of companies making such claims for their products.
That was all they had to do, and all we were asking for. Hold homeopathic products to the same requirement for evidence to back any clinical claims that they make. In essence, all we wanted was for them to do their job. The FTC now seems willing to do just that.
They further explain that companies can make claims for products based on things other than reliable scientific evidence, but that they then have to clearly explain the basis of those claims:
However, the policy statement also notes that “the FTC has long recognized that marketing claims may include additional explanatory information to prevent the claims from being misleading. Accordingly, it recognizes that an OTC 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 essence, the net effect of the labeling on the product cannot be misleading to the consumer. I think this is giving some wiggle room for homeopathic manufacturers to try their best to mislead their potential customers, but this is probably the best the FTC can do within its mandate.
The FTC statement specifically notes that this policy does not violate the first amendment, which signals their primary concern. Companies still have the free speech to tell the public that they believe from their traditions that a product can work for a specific indication, as long as they also say this is not based on evidence or on modern accepted scientific concepts.
This all means that it is more important than ever to educate the public about the true nature of homeopathy. The new FTC policy only really works if the public has a basic level of scientific literacy. That is a much longer struggle.
Three other organizations skeptical of homeopathy, The Society for Science-Based Medicine (SSBM), The Center for Inquiry, and the Richard Dawkins Foundation for Reason and Science (the RD Foundation), also submitted comments. The comments argued that homeopathic products have no efficacy in treating illnesses and that there is no reasonable basis for homeopathic principles such as “like cures like,” the law of infinitesimal doses, or water retaining a memory of things that have been in contact with it. They pointed to the Australian NHMRC report, to a report by the UK House of Commons Science and Technology Committee that “could find no support from independent experts for the idea that there is good evidence for the efficacy of homeopathy,” and to a statement by the National Center for Complementary and Integrative Health that “There is little evidence to support homeopathy as an effective treatment for any specific condition.” The SSBM asserted, based in part on its reading of individual public comments submitted to the FDA, that consumers do not understand the nature of homeopathic drugs or the support for their claims.
If you have time the document is an interesting read. It includes comments from the homeopathic industry, which is unsurprising. They argue that homeopathy must work because people use it, and that there are positive studies of homeopathy. These are the same tired, deceptive claims they typically make.
When it comes to medical treatments, the argument from popularity is worthless because of placebo effects and the inherent difficulty of knowing if a treatment is helpful from anecdotal observation. Bloodletting was very popular for centuries. Further, they continue to cherry pick the studies they want, ignoring or dismissing the many systematic reviews which clearly show that homeopathy does not work for anything.
The bottom line is that, after more than 200 years of use, homeopaths have failed to provide solid scientific evidence that any homeopathic remedy works for any indication. They will give a lot of hand-waving explanations for why this is true, but they all fall flat. The simplest explanation for this lack of scientific evidence is that homeopathy does not work.
What about the FDA?
The FTC essentially regulates the marketing of products, their labeling, and the claims that can be made for them. They don’t regulate the products themselves, that is up to the FDA.
We are still waiting to hear the FDA’s decision on homeopathy. We hope, like the FTC, that they choose to do their job. All they have to do is enforce their mandate, and hold homeopathic “drugs” to the same requirements for evidence of safety and efficacy as all other actual drugs.
If they really do this, then I don’t see how the homeopathic OTC product market can survive. It is clear that they cannot provide scientific evidence for efficacy.
The realist in me (some might say pessimist) thinks that the FDA will tighten up regulations of homeopathy, but for political reasons will give the industry a loop hole. I predict they will simply require more accurate labeling of homeopathic products, but not require them to provide evidence of efficacy in order to remain on the market at all.
I am still hopeful they will go the distance and do the only rational and honest thing – regulate homeopathic products by the standards demanded by their category. Remember, the privilege of disease claims go hand-in-hand with high standards of scientific evidence. The FDA carved out a special exception for homeopathy, and all they need to do is make that exception go away.
If they do this, effectively shutting down the OTC homeopathy industry, I further predict that Congress will act to save the industry. They shouldn’t. They should let it die a merciful death. If only our world were that rational. Perhaps I will be pleasantly surprised.
Congress controls the FDA. They can easily pass a law that creates whatever regulatory scheme for homeopathy that they want. They did this for supplements with the Dietary Supplement Health and Education Act of 1994. This is pro-industry, anti-consumer regulation. If history is any guide, they will do the same thing for the homeopathy industry.
There is a glimmer of hope, however. Note that the FTC heard the voice of skeptics, both individuals and organizations. We have a powerful voice, if not in numbers then in the logic and evidence that backs our opinions.
Now is the time to keep the pressure up. If the FDA returns a good decision on homeopathy, we have to anticipate how the industry will respond. The decision could backfire if Congress decides to act, and things could actually get worse. Our collective voice will be more necessary than ever.
The FTC has set the stage. When the FDA gives their decision, and especially if it is a science-based one, we cannot take time to celebrate. That will be a dangerous time, and we must snap into action as quickly as the homeopathic industry surely will.
This will be an opportunity to educate the public and our politicians about homeopathy. We need to make clear that the public expects health care products to be safe and effective, and that they not be deceived by false or misleading claims. We will all need to write our representatives, to make the voice of science and reason heard as loudly as possible.