“Efficacy and Safety Claims Are Held to Same Standard as Other OTC Drug Claims.”
On November 15, 2016, the Federal Trade Commission announced a new "Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopathic Drugs.[1] This news bulletin is reproduced here in its entirety:
The policy statement was informed by an FTC workshop held last year to examine how such drugs are marketed to consumers. The FTC also released its staff report on the workshop, which summarizes the panel presentations and related public comments in addition to describing consumer research commissioned by the FTC.
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.
Homeopathy, which dates back to the 1700s,[2] is based on the theory that disease symptoms can be treated by minute doses of substances that produce similar symptoms when provided in larger doses to healthy people. Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance. According to the policy statement, homeopathic theories are not accepted by most modern medical experts.
For the vast majority of OTC homeopathic drugs, the policy statement notes, "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." As such, the marketing claims for these products are likely misleading, in violation of the FTC Act.
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.
The policy statement notes that any such disclosures should stand out and be in close proximity to the product's efficacy message and might need to be incorporated into that message. It also warns marketers not to undercut a disclosure with additional positive statements or consumer endorsements reinforcing a product's efficacy. The statement warns that the FTC will carefully scrutinize the net impression of OTC homeopathic marketing claims and that if an ad conveys more substantiation than a marketer has, it will violate the FTC Act.
The Commission vote approving the enforcement policy statement and issuance of the staff report on the Homeopathic Medicine & Advertising Workshop was 3-0.
“Efficacy and safety claims for homeopathic drugs are held to the same standards as similar claims for non-homeopathic drugs.” This statement is not unreasonable, on the face of it. The dilemma, of course, lies in the definition of “competent and reliable scientific evidence” as defined by one’s definition of “qualified persons”, and who makes up the profession. If we are talking about qualified homeopaths, then there is no problem. If we are talking about those who have no knowledge or experience of homeopathy, then obviously there will not be agreement.
Like everything we do, our claims are based on the “proof of the pudding being in the eating” principle, and those who hate homeopathy with a passion will use this to vilify the whole philosophy. Those who are open-minded or who have experienced the benefits of homeopathy will continue to be open-minded. My patients who have chest ports placed will continue to use arnica to help with post-traumatic bleeding and bruising – we don’t have to claim that it cures anything, just that some people have found it helpful, and have found that they don’t bruise as much as other people who have undergone the same procedure. There are many published articles on the use of arnica for bruising injuries. A Google Scholar search gives 2,460 results, most of them in the peer-reviewed literature and indexed in MedLine.
The “scientific” mind is sometimes closed to other options. It’s a shame, but we are not going to change them by vituperating or forcing them to change. They will eventually come to realize the limits of their philosophy – or they won’t – and nothing that we do will make much difference until they are ready to change. We can knock at the door all we like, but either we are compelled to break it down (the more Newtonian principle) or we wait, and allow the door is opened by those who are inside – when and if they choose to open it.
The FTC statement goes on to read: “truthful, non-misleading, 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 the limited basis for the claim in the manner discussed above.” We are not trying to persuade people that homeopathic remedies work – we all know that their effect can be very powerful. We are just offering options and alternatives which some people have found to be helpful.
I personally choose not to attempt to break down the door. There is no fire, there is no immediate threat to life or limb. The only threat to homeopathy is if we allow it to be a threat. We don’t have to claim to cure anything, as I said. We can say that many people find this remedy helpful for whatever symptoms we are wanting to treat – and leave it at that. No claims, just an offer of assistance.
[1] FTC Issues Enforcement Policy Statement Regarding Marketing Claims for Over-the-Counter Homeopathic Drugs
[2] Samuel Hahneman was born in 1755 in Germany and died in 1843 in Paris. He enrolled at the University of Leipzig to study medicine, and transferred to the University of Vienna because the first school had neither hospital nor clinic available for students. He finally registered at the University of Erlangen and finished his schooling. He moved to Dresden in 1784 and became a translator of medical texts. For the next 20 years he moved from place to place, working as a translator and not practicing medicine at all. During this time he was able to learn about every system of medicine, because of his translation wok. In 1790 he made his first experiment with the medicine called Cinchona, given as a specific for malaria at the time. He disagreed with the conventional wisdom that the medicine worked because it tonified the stomach. He decided to take the medicine himself, and observe the effects on himself. To his great surprise, he observed symptoms very similar to malaria including intermittent fever. Over the next fifteen years he developed a large collection of effects of different herbal and natural medications when given to healthy volunteers (mostly his family). In 1804 he began to write about the experience. He began to develop a system of medicine which relied on single drugs in harmless doses, based on observation and experiment.
In 1812 he moved back to Leipzig, with the intention of taking on the medical establishment. Unfortunately he fell into the habit of haranguing the establishment, and lost his student following. Orthodox medicine began increasingly coordinated attacks on the form of medicine that Hahneman was teaching. The government decreed that doctors were no longer allowed to make or dispense their own medications, thus barring him from the legal practice of medicine.
In 1820 he moved to Coethen where he was allowed to prepare his own medicines, and where his continued to update the Organon and Materia Medica. He developed the theory of miasms during this period. His wife died.
In 1834 he met his (soon to be) second wife, Melanie. She became his patient and eventually his wife, exposing Hahneman once again to vilification – not unlike what would happen today, where sexual relations with a patient are considered to be unprofessional conduct by almost all the licensed healing professions. In Hahneman’s case, after moving to Paris with his new wife, he became a celebrity, the preferred physician of the rich and famous. With the help of his new wife, the Materia Medica and the Organon were completed. [information 04-02-17 from http://www.heilkunst.com/biography.html]