All Eyes on Homeopathics: FTC Workshop Signals Targeted Regulatory Scrutiny of Homeopathic Products
On Tuesday, the Federal Trade Commission “FTC” announced it will be hosting a workshop in September to evaluate advertising for over-the-counter homeopathic products. Homeopathy is an alternative medicine practice dating back centuries that incorporates the principle of “like cures like,” which holds that a given disease’s symptoms are “healing responses” that can be replicated by the appropriate medicine to cure that very same disease. Although homeopathic drugs are regulated by the Food and Drug Administration (“FDA”), advertising in the now multibillion dollar homeopathic drug market is also regulated by the FTC. Given the agencies’ prior collaborations on the promotion of FDA-regulated products (e.g., caffeinated alcoholic beverages, health-benefit claims for conventional food products, and anti-aging clams for personal care products), it is not surprising that the two agencies are now working together to consider the sale and marketing of homeopathic products. The FTC workshop comes at the heels of a two-day FDA public hearing this past April, entitled “Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework After a Quarter-Century,” where the FDA sought insight from homeopathy industry leaders and stakeholders on homeopathic drugs and FDA’s regulatory framework. Speakers at the hearing included representatives from the Homeopathic Pharmacopoeia Convention of the United States, the Consumer Healthcare Products Association, the American Institute of Homeopathy, and the American Association of Homeopathic Pharmacists. While the FDA workshop focused primarily on the regulatory status of homeopathics and their appropriate placement in FDA’s regulatory framework, it appears that the FTC workshop will focus on the requisite competent and reliable scientific evidence to substantiate advertising claims for the products.. While we will continue to monitor developments in this area and provide updates via AdLawAccess, more information about the FTC’s workshop and how to participate can be found here. FDA will continue to accept written or emailed comments until June 22, 2015. A full transcript of the FDA hearing is available at http://www.regulations.gov.