On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory framework to homeopathic drugs. The comment responds to FDA’s March 27, 2015 announcement of a public hearing on the topic and request for “comments on other matters related to the development and regulation of drug and biological products labeled as homeopathic.”
Under its 1988 Compliance Policy Guide (CPG), FDA permits the manufacture and distribution of OTC homeopathic products without FDA approval provided certain conditions are met including that they are “intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms).” Conversely, products offered for conditions not amenable to OTC use must be marketed as prescription products and be approved by FDA prior to being manufactured or distributed. In encouraging FDA to reconsider this framework, FTC staff suggested that FDA’s requirement that homeopathic drugs display an indication for use “even when the product has not been demonstrated to be efficacious for that indication” is inconsistent with the FTC’s requirement that health claims be substantiated by competent and reliable scientific evidence. FTC staff further noted that the potential conflict does not exist for other products such as dietary supplements and non-homeopathic drugs because both FTC and FDA law require substantiation to support efficacy claims for non-homeopathic products.
The comment also cites a National Advertising Division (NAD) case in which an advertiser defended its claims for a homeopathic product on the grounds that neither the FDA nor the FTC required substantiation for such claims. Staff noted that the FTC has always required substantiation for such claims, but that “staff has been reluctant to pursue cases against OTC homeopathic products because the Commission’s traditional remedies, such as requiring that health claims be supported by competent and reliable scientific evidence, could create a potential conflict with FDA policy under the CPG.” Staff also cited consumer research suggesting that many consumers do not understand the nature of homeopathic products, how they are regulated, or the level of substantiation required for such products as further support for FDA reevaluating its approach.
While the staff comment did not expressly advocate for a particular resolution, it noted that the current potential conflict could be resolved in three ways: (1) FDA withdrawing the CPG and subjecting homeopathic drugs to the same regulatory requirements as other drug products, (2) FDA eliminating the requirement in the CPG that an indication appear on the labeling, or (3) FDA requiring any indication appearing on the labeling to be supported by competent and reliable scientific evidence but otherwise maintaining the current regulatory approach. While not noted in the comment, the second approach, however, would not seem to address FTC’s concerns about consumer confusion as to the efficacy and nature of homeopathic products.
The comment period for submission of comments to FDA closed on Friday, August 21. We will continue to monitor developments related to the regulation of homeopathic products here.