The FDA is no doubt pulling the strings on this.
The Federal Trade Commission (FTC) recently issued a policy statement explaining that the agency will hold efficacy and safety claims for over-the-counter (OTC) homeopathic drugs to the same standard as claims for other OTC drugs. This means homeopathic OTC products will need to back up claims with “competent and reliable scientific evidence” for health-related claims, or else use certain FDA-approved disclaimers.
Here are some examples of acceptable disclaimers, as noted in the FTC’s policy statement: “There is no scientific evidence that the product works,” or “The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”
We’ve been expecting this attack on homeopathy for some time. Last year, the FTC held a workshop to discuss the advertising of OTC homeopathic formulations. The FDA also held a public hearing to evaluate enforcement policies for homeopathic drugs.
The pretense for such actions, of course, is consumer protection and safety, but there’s little reason to believe this is genuine. No one has any concern for properly produced homeopathic products, which have been used for centuries without harm. These medicines are often so diluted that the original ingredient is virtually undetectable. Homeopathic products must also go through an approval process with a monograph from the Homeopathic Pharmacopoeia of the United States, which ensures homeopathic products are both safe and effective.
The most likely motivation of the FTC is that the homeopathic industry is rapidly expanding, which presents a clear threat to pharmaceutical drug company profits, which is enough for the FDA to put homeopathy in its scopes. The FDA often works in conjunction with the FTC, as we’ve seen in similar attacks on advertising claims of natural products (e.g., the case of POM Wonderful).
This is all contrary to the expressed choices of consumers. In a survey of 20,000 consumers who had purchased at least one OTC homeopathic product in the past two years, more than 96% said they were very or extremely satisfied with the results of the homeopathic medicines they had used.
As of yet, no official rule or guidance on this issue has been proposed, so we have no opportunity for engagement. We will be monitoring the situation closely. When the time comes, we must let the FTC and FDA know what we think of their crony capitalist move.