FTC Staff Recommends That FDA Reconsider Its Regulatory Framework for Homeopathic Drug Products

August 23, 2015

By Riëtte van Laack - 

As we previously reported, FDA and FTC are reviewing their regulation of homeopathic drugs.  In March 2015, FDA issued a notice requesting comments on the current use of homeopathic drugs, and that agency’s approach to regulation of the category.  In June 2015, FTC announced a workshop in September to discuss advertising of over-the-counter (OTC) homeopathic products. 

Last week, FTC staff announced that it has submitted a comment to FDA.  The comment was approved by the Commission by a vote of 5-0.  Not surprisingly, FTC staff takes the position that claims for homeopathic drugs must be supported by competent and reliable scientific evidence.  The comment suggests that FTC believes that its position is compromised by FDA’s current conflicting policy that allows marketing of homeopathic drug products without proof of efficacy. FTC staff suggests that it has been “reluctant” to pursue action against homeopathic products because of this conflict.

FTC staff puts forward three possible approaches for FDA to resolve the conflict between FDA’s policy and FTC’s substantiation doctrine:

  1. FDA discontinues its current policy and requires that homeopathic products meet the same standard as other conventional OTC drug products;
  2. FDA removes the requirement for an indication for homeopathic drug products so that the inclusion of the indication becomes voluntary and, therefore, is no longer “sanctioned” by FDA but remains subject to FTC’s standard of competent and reliable scientific evidence;
  3. FDA amends the current policy to require that the indication be supported by “competent and reliable scientific evidence.”

The FTC staff’s comment includes data from two studies – a focus group and copy test – to support its contention that consumers are confused about the nature of homeopathic products.  These studies and their interpretation will undoubtedly be a topic of discussion at FTC’s September workshop. 

The comment confirms that FTC is intent on holding homeopathic drug products to the same standard as conventional drug products.  The question now is whether FDA will accept the comment’s recommendations in furtherance of that objective or if FDA will continue to recognize the uniqueness of homeopathic drug products.