As we reported here and here the FDA held a public hearing on April 20 and 21 to discuss a review of the regulatory enforcement policies relative to homeopathic drugs. The docket was open for public comment and we learned that the Federal Trade Commission (FTC) submitted its comments to the docket August 21, 2015.
The FTC comments parallel some of the views expressed at the hearing, but take a slightly different approach zeroing in on the advertising of claims of these marketed products, while FDA concentrated on the labeling of most product. As the comment states:
The FTC staff is concerned that the FDA’s existing regulatory framework may conflict with the Commission’s advertising substantiation policy in ways that may harm consumers and create confusion for advertisers. These concerns are bolstered by the results of FTC staff research exploring consumers’ understanding and perceptions of homeopathy and homeopathic drugs. As explained below, this evidence suggests that a significant percentage of consumers do not understand homeopathy, how the FDA regulates homeopathic drugs, or the level of scientific evidence supporting homeopathic claims.
The FDA is also planning a public workshop on September 15, 2015 to hear various views on the advertising of homeopathic products. The FTC’s comments go on to explain that while the marketing of homeopathic drugs are enforced under a compliance policy guide of the FDA (Compliance Policy Guide (“CPG”) 400.400 entitled, “Conditions Under Which Homeopathic Drugs May be Marketed,” which permitted the manufacture and distribution of homeopathic products without FDA approval), however, the products themselves have never undergone a review for efficacy.
The FTC goes on to describe a “potential conflict between FDA’s regulatory framework and FTC’s advertising substantiation policy.” In research conducted by or for the FTC on the perception of homeopathic products they conclude that “(M)any consumers may incorrectly believe these products are pre-approved by the FDA and tested on humans for efficacy. To add to this confusion, homeopathic products are placed side-by-side in retail stores throughout the United States next to products that are actually pre-approved by the FDA and tested on humans for efficacy. Finally, homeopathic product labels are confusing and do not conform with conventional product labeling. A consumer’s choice to use homeopathic medicine based on the above factors could cause harm. The FTC staff believes that the FDA should take these factors into consideration in its review of the regulatory framework for homeopathic products.” And finally they state: “Accordingly, the FTC staff recommends that the FDA reconsider its regulatory framework for homeopathic medicines to address the concerns discussed in these comments.” The full text of the FTC comment can be found here.
Where will this go? Only time will tell, but it looks like the time has come for the FDA to make the rubber meet the road by making some decision consistent with the statutory and regulatory principles embodied in the legislation, especially in today’s environment, and putting this issue to bed once and for all.