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FTC Issues Long-Awaited Enforcement Policy on OTC Homeopathic Drugs

We reported a few weeks ago about a new warning from FDA related to the safety of certain teething-related, non-prescription homeopathic drug products, and in that post we mentioned that both FDA and the Federal Trade Commission (FTC) held public workshops in 2015 to gather information about this uniquely-regulated class of consumer products.  Today, FTC released an Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs  (available here); a Staff Report on the discussions held during the September 2015 workshop (available here); and an FTC blog post summarizing these actions.

For readers who are not familiar with homeopathy, the practice dates back to the 1700s and posits that disease symptoms can be treated by tiny doses of substances that produce similar symptoms if given in larger doses to healthy people ("like cures like").  Accordingly, modern-day homeopathic remedies that we find ubiquitously in drug stores today are highly diluted formulations, which some people consider to be no more effective than placebo.  The FTC Staff Report provides an excellent overview of how this OTC industry has grown over the past 50 years and the viewpoints presented by both supporters and skeptics of homeopathy.

 The upshot to the new FTC Enforcement Policy is this:
 "No convincing reasons have been advanced either in the comments or the workshop as to why efficacy and safety claims for OTC homeopathic drugs should not be held to the same truth-in-advertising standards as other products claiming health benefits."

Sounds deep, but it's pretty simple.  It means that advertising and promotional claims for non-prescription homeopathic products marketed to consumers must be adequately substantiated, and specific safety or efficacy claims need to be supported with "competent and reliable scientific evidence" - in other words, the product's marketing has to meet the standards set by FTC for all other consumer products.  But for the most part, FTC explains, OTC homeopathic drugs are supported only with traditional homeopathic theories and so-called provings, "which are not accepted by most modern medical experts and do not constitute competent and reliable scientific evidence that these products have the claimed treatment effects."  As a consequence, current marketing claims for this class of products are likely misleading in violation of the FTC Act.


However, FTC also recognizes that consumers have a right to access alternative therapies as long as they are not misled or deceived by advertisers.  So consumers must be informed (conspicuously and effectively) that the products have not been clinically tested for efficacy.  There are well-established standards for how to make effective disclosures in advertising, of course, and in this particular case, FTC's Enforcement Policy also lays out clearly what additional information may be necessary to prevent certain homeopathic claims from being misleading - these disclosures should include that:

  1. There is no scientific evidence that the product works.
  2. The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.

FTC's statement also notes the "inherent contradiction" in telling consumers that a product is effective and simultaneously telling them that there’s no scientific evidence for that assertion.  In light of that incongruity, it is possible that even those clear disclosures may not prevent consumer deception - and on that problem, FTC advises companies to develop extrinsic evidence, such as consumer surveys, to determine the net impression being taken away from their marketing materials.

This FTC Enforcement Policy represents a turning point for the consumer-focused homeopathic industry.  It remains to be seen whether FDA also decides to reform its historical approach to OTC homeopathic drugs, and whether FDA chooses to either revise or withdraw a 1988 policy document that outlines conditions under which such products can be marketed without a demonstration of effectiveness.  And of course the change in Administrations that we will experience after January 20, 2017 may have an affect on these executive branch policies and priorities.  Stay tuned!

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Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.