On September 21, 2015, the Federal Trade Commission (FTC) held an all-day workshop in Washington, D.C., titled, “Homeopathic Medicine & Advertising.”
The homeopathic drug industry has been under increased scrutiny following a variety of class action lawsuits against homeopathic drug makers such as Boiron which settled for $5 million in refunds in 2012, Standard Homeopathy (collectively Hyland’s) which is currently in litigation, as well as Nature’s Way, Boerick & Tafel and NatraBio which are pending. These suits accuse the companies of making false claims regarding their effectiveness in treating a variety of ailments.
Currently, under the Compliance Policy Guide 7132.15 Sec. 400.400, homeopathic products are exempt from Section 211.165 (Testing and release for distribution) in Title 21, Volume 4 of the Food and Drug Administration’s Code of Federal Regulations. This is due to their impressive safety record but on April 21 and 22 of this year, the FDA held a public hearing to evaluate their current regulatory standards. The American Association of Homeopathic Pharmacists (AAHP) argued at the hearing that the current regulatory standards make homeopathic products sufficiently safe to consumers and that a majority of manufacturers adhere to these standards regarding the way products are labeled.
Similarly, at the FTC workshop, the AAHP cited research which showed that a majority of consumers are informed about the FDA’s role in the approval of homeopathic product categories, even without an appropriate disclaimer. “This study showed that 24% of the consumers tested believe that FDA approved homeopathic drug claims,” explained Al Lorman, a lawyer for the AAHP. “This 24% is within the range found by the FTC in its study of a couple of years ago.” In a separate study by the AAHP, testing the effects of three different disclaimers on product labels, results showed that when one of the three disclaimers was applied to a label, between 1-8% of consumers believed homeopathic product claims were approved by the FDA. These disclaimers they used were: 1. These statements have not been approved by the Food and Drug Administration. 2. The uses of our products are based on traditional homeopathic practice– they have not been reviewed by the Food and Drug Administration. 3. The uses of our products are based on traditional homeopathic practice (see www.homeopathic.org).
Published in WholeFoods Magazine Online (online 10/5/15)