Last year, two important regulatory agencies in the U.S. undertook to review their regulation of over-the-counter homeopathic remedies. The evidence is clear that homeopathy is nothing more than a placebo, but it has persisted for historical and cultural reasons. As I discussed in an earlier post, the Food and Drug Administration (FDA), which has legal authority over the selling of such remedies, solicited public comment in 2015 on the possibility of changing its very permissive policies on such remedies. That review is still underway.
The Federal Trade Commission (FTC), also took comment on its regulation of the advertising for homeopathic products. While the FTC, unlike the FDA, cannot set conditions for the sale of these remedies nor prohibit their sale, it can require truthful advertising, which in the case of homeopathy would mean declaring it to be a placebo with no scientific basis. Amazingly, that is exactly what the FTC has done in its final report. Here is the core of the findings:
The FTC Act does not exempt homeopathic products from the general requirement that objective product claims be truthful and substantiated. Nevertheless, in the decades since the Commission announced in 1972 that objective product claims must be substantiated, the FTC has rarely challenged misleading claims for products that were homeopathic or purportedly homeopathic.
For the vast majority of OTC homeopathic drugs, 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. Accordingly, marketing claims that such homeopathic products have a therapeutic effect lack a reasonable basis and are likely misleading in violation of Sections 5 and 12 of the FTC Act.
In summary, there is no basis under the FTC Act to treat OTC homeopathic drugs differently than other health products. Accordingly, unqualified disease claims made for homeopathic drugs must be substantiated by competent and reliable scientific evidence.
Nevertheless, truthful, nonmisleading, effective disclosure of the basis for an efficacy claim may be possible. The approach outlined in this Policy Statement is therefore consistent with the First Amendment, and neither limits consumer access to OTC homeopathic products nor conflicts with the FDA’s regulatory scheme. It would allow a marketer to include an indication for use that is not supported by scientific evidence so long as the marketer…effectively communicates to consumers 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.
What the FTC has done is essential what skeptics asked for. Homeopathic remedies may still be sold and advertised, since the agency has no authority to prevent this, but they must be advertised truthfully. This means that any claim that such remedies have any effects must either be supported by legitimate scientific evidence (which is impossible since no homeopathic remedy has ever been scientifically proven to work), or it must be accompanied by a clear statement that the claim is based on 18th century theories unsupported by science and believed by the vast majority of scientists to be false.
I suspect that enforcement of this policy will be limited if not non-existent, especially given the anti-science and post-fact nature of the incoming presidential administration. However, the ruling at least shows that non-politicians in government do hear and consider the voices of skeptics and scientists related to science-policy issues.
In summarizing the comments the agency received during its review, the FTC noted that, “The vast majority of the comments received were from individual consumers who had personally used homeopathic products.” Of 530 public comments received, 400 were from users of homeopathy and 30 from homeopaths. Only 50 individuals (myself included) wrote to express a skeptical view of homeopathy. However, several organizations, including Sense About Science, the Society for Science-based Medicine, the Center for Inquiry, and the Richard Dawkins Foundation for Reason and Science contributed opinions. Ultimately, the logic and evidence of the skeptics won out over the greater number of comments promoting homeopathy through personal faith and anecdote. Though one lesson from this is that skeptics need to get off their lazy butts and share their views more often, a more optimistic lesson is that sometimes science and reason can carry the day even when, sadly, it is the perspective of the minority
So, what this boils down to is that manufacturers and distributors of homeopathy are left with three choices.
1st choice (substantiated scientific evidence of efficacy) : it will be a cold day in hell for them to spend 2 trillion for RCTs on 100 ingredients, so nix that, consumers will still be left with ineffective products.
2nd choice (replace current misleading claims with explanation of why the product is ineffective) : it will be another cold day in hell before they stamp “PLACEBO” on the product packaging, so nix that, the consumers will still be left with ineffective products, but still clearly thinking they are effective because. Quack Miranda Warning. (which as we know, did nothing in the last decades, consumers did not become wiser, but they became complacent, and that little warning has gotten to be the smallest print ever).
3rd choice (replace current labeling with indication that it is a 1700’s theory and people all over the world have used homeopathy based on a theory and lots of doctors and veterinarians believe in homeopathy based on a theory and Big Gubmit is making them include this statement) : they will bend over backwards to pretty up the labeling, and possibly spend 2 trillion in new labeling and advertising. Business. As. Usual. The consumer is still misled and left with ineffective products.
Did I miss anything?
I commend the FTC for their hard work, and for not being so brainless as to allow this disgusting charade to go on, at least where advertising is concerned. I’m still waiting to see what the FDA does, but not holding my breath they will do right by consumers.
Last year, two important regulatory agencies in the U.S. undertook to review their regulation of over-the-counter homeopathic remedies. The evidence is clear that homeopathy is nothing more than a placebo, but it has persisted for historical and cultural reasons. As I discussed in an earlier post, the Food and Drug Administration (FDA), which has legal authority over the selling of such remedies, solicited public comment in 2015 on the possibility of changing its very permissive policies on such remedies.