As readers of this blog know, the FTC takes health claims seriously. The FTC has recently turned its attention to homeopathic remedies, expressing concerns over consumers’ understanding of what these products are, how they are tested, and their efficacy, as well as inconsistencies between FTC and FDA requirements. The FTC will be hosting a workshop on September 21 to examine advertising for homeopathic products. The FTC also recently submitted comments on the FDA’s regulatory framework for homeopathic products. The FTC recommends that the FDA modify its regulatory approach because it is inconsistent with FTC law and likely to confuse consumers about the efficacy of homeopathic products.
Homeopathy is, in the FDA’s words, “[t]he practice of treating the syndromes and conditions which constitute disease with remedies that have produced similar syndromes and conditions in healthy subjects.” Even though homeopathic products are drugs under the Food, Drug, and Cosmetics Act, the FDA’s 1988 Compliance Policy Guide (“CPG”) § 400.400 permits claims on homeopathic products about treating certain types of conditions without demonstrating the products’ efficacy, a key requirement for non-homeopathic drugs. In defense of the FDA’s approach, sellers of homeopathic products argue that many homeopathic products have a long history of safe use with reported efficacy, are relatively inexpensive, and lack the intellectual property protection that would justify the expense of clinical studies that are required for non-homeopathic products. FDA estimates sales of homeopathic drugs in the United States at $2.9 billion annually.
The FTC has overlapping authority to regulate advertising claims for homeopathic products under the FTC Act. The FTC generally requires health claims to be supported by competent and reliable scientific evidence. Thus, as the FTC explains in its comments, the FDA’s approach creates a potential conflict with the FTC’s substantiation requirement. Because of this potential conflict, the FTC notes that it has been reluctant to bring enforcement actions concerning homeopathic products. Although the FTC has not announced a change in this enforcement stance, such a change may come if the FTC concludes that whatever changes the FDA makes to its regulatory approach do not adequately address the risk of consumer harm, principally that consumers may forgo non-homeopathic products that have been shown to be effective.
The FTC discussed in its comments the results of consumer perception research it conducted on homeopathy and homeopathic products. The FTC believes the research suggests that consumers do not understand homeopathy and that the existing labeling requirements lead them to conclude erroneously that the FDA has approved homeopathic products for efficacy.
As its comments make clear, the FTC believes that homeopathic products should be subject to more stringent regulation, contrary to longstanding FDA policy. It remains to be seen how the FDA will respond and what the FTC will do if it thinks that the FDA’s response is inadequate.