On Monday, September 21st the Federal Trade Commission (“FTC”) held a workshop entitled Homeopathic Medicine & Advertising (“workshop”). The workshop consisted of three panels: one discussing the homeopathic industry parameters generally, one discussing the science of homeopathic medicine, and the last discussing the legal and regulatory issues surrounding the marketing of homeopathic medicines.
Important Points of Discussion:
There was a great amount of dialogue during the day, however, here are some interesting points of discussion that could have significant impact on persons who market homeopathic drug products:
- There was a very spirited debate during the scientific panel regarding the type of evidence that is needed to support homeopathic medicine and claims for homeopathic drugs. Most panelists that were not doctors of homeopathic medicine strongly defended the need for randomized, placebo-controlled, double-blinded, trials in humans (RCTs) to support specific claims for specific products and rule out the placebo effect as the source of consumer benefit from homeopathic products.
- Rich Cleland, Assistant Director of the FTC’s Division of Advertising Practices, asked the Panel 2 scientists whether there was any reason why RCTs could not be used for homeopathic products. While there was a debate about the usefulness of other types of studies, no panelists asserted that there was a reason why these trials could not be done to support specific performance/efficacy claims for specific homeopathic products. Michelle Rusk a senior staff attorney in the FTC’s Division of Advertising Practices who sat on the last Panel on regulatory and legal issues, reiterated this point as one of her takeaways from the scientific panel.
- FDA members of the panels and other panelists repeatedly stated that there is a great amount of variation between processing/dilution methods used and botanicals actives from product to product. Because of this variation, some panelists stressed the need for product specific research to mitigate the effects of variations in processing and dilution methods between companies.
- On the last panel on legal and regulatory issues, Michelle Rusk of the FTC expressed opinions on a number of key issues for marketers. She expressed great skepticism that disclaimers could be used to adequately limit the claim and explain to consumers the limitations of the evidence supporting a given homeopathic product. She also stated that she believed that claims relating to traditional uses of homeopathic medicine and products should be held to the same standards for traditional use claims in the FTC guidance, Dietary Supplements: An Advertising Guide for Industry. Lastly, she reiterated that her take away from the science panel was that there was no reason why RCTs cannot be used to substantiate product performance claims for specific homeopathic products.
FDA’s Evaluation of Its Homeopathic Policy
It’s important to note that the FTC’s consideration of the advertising of homeopathic drug products is taking place at the same time that the Food and Drug Administration (“FDA”) is evaluating its current regulatory framework for homeopathic drugs. In April of this year, the FDA held a two day meeting to get information and comments from stakeholder’s regarding the FDA’s regulatory framework for homeopathic drug products. More information about the FDA’s action can be found on its website. The FTC staff has submitted a comment to the FDA detailing the FTC’s concerns regarding how the FDA’s regulations impact the advertising for these products. However, the FTC did not indicate during the workshop whether they planned to coordinate with the FDA either temporally or substantively with regards to the actions that they may take going forward regarding the regulation of homeopathic product advertising.
The FTC will be accepting comments until November 20th on the issue of advertising for homeopathic medicines. Presumably, after the agency considers all comments, the agency will communicate in some way its thoughts or policies regarding advertising for homeopathic products going forward, however, FTC did not state that they planned on issuing any statement or policy or what form any agency statement would take.
FTC’s workshop webpage includes a complete agenda and speaker biographies.