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September 24, 2015
On September 21, the Federal Trade Commission held its all-day workshop on homeopathic medicine and advertising. Three panels presented on "Homeopathic Industry and Advertising," "Scientific Support for Homeopathic Advertising Claims" and "Legal/Regulatory Issues Presented by Homeopathic Advertising." There were interesting discussions on the history of homeopathy, the nature of homeopathic "provings," and what consumer surveys tell us about the public's understanding of the current regulation of—and science supporting—homeopathic products. There was even a heated exchange between attorneys on opposite sides of the consumer class action wars.
The homeopathic industry has grown to almost $3 billion, and there are more than 7,000 homeopathic products registered with the FDA.
The FTC emphasized that the subject of the workshop was not the practice of homeopathy (which neither it nor the FDA regulates), but rather the advertising of OTC homeopathic drug products, which is squarely in its jurisdiction.
Of course, the main question is how, if at all, FTC will change its approach toward the regulation of OTC homeopathic product advertising. While the FTC was clear that it had made no decisions, it seems that some tea leaves can be read.
Michelle Rusk, senior staff attorney of the FTC's Division of Advertising Practices, stated that FTC had no special rules for homeopathic products and that, in general, health claims for products must be supported by randomized, placebo controlled studies showing both statistically significant and clinically relevant results. Rich Cleland, the assistant director of the Division of Advertising Practices, moderated the scientific panel and generally seemed very skeptical of the value of anything less than that type of study, including traditional homeopathic provings, in supporting efficacy claims.
Kathleen Dunnigan, senior staff attorney of the National Advertising Division of the Council of Better Business Bureaus (NAD), stated that NAD's approach was generally consistent with the FTC's, and that homeopathic provings, or inclusion of ingredients in the Homeopathic Pharmacopeia, did not constitute adequate substantiation for advertising claims.
Several panelists argued that disclaimers, such as those currently required for dietary supplements ("These products have not been evaluated by the FDA"), would adequately prevent consumer deception. Rusk stated that, at best, such a disclaimer would correct any consumer misunderstanding with respect to FDA approval but would not correct any mistaken belief that homeopathic products have been tested for efficacy.
As to claims based on "traditional use," Rusk cautioned that such claims are very limited and must effectively convey to consumers that the claimed traditional use is not supported by research, and the fact of traditional use does not mean that the product will have that effect. (In the FTC's experience, it is very difficult to craft a disclaimer that claims are not supported by science.)
Panelists representing the industry did a good job advocating the value of consumers having a choice in treatments, the high levels of consumer satisfaction with homeopathic products, different ways of evaluating products' effectiveness, and the perils, including costs, of unnecessary regulatory burdens. Gregory Fortsch, an attorney with the FTC's Division of Advertising practices who chaired the event, emphasized that the commission will consider those comments, as well as all comments received from the public (which can be submitted until November 20). However, from the tone and contents of the FTC's remarks at the workshop, it certainly does not seem that it is likely to relax its regulation of OTC homeopathic product advertising, and that must be considered when developing future advertising campaigns for such products.
Like dietary supplements, homeopathic products can be advertised, but it must be done right.
Partner, Amin Talati Upadhye
Ivan Wasserman is one of the nation’s premier attorneys for health, wellness, beauty and other consumer products. Companies of all sizes making, marketing and selling food, dietary supplements, cosmetics, over-the-counter drugs and medical devices praise the depth of his knowledge and experience, his humor and his ability to maintain the human perspective while leading them through this heavily regulated landscape. Frequently cited by the media as a legal authority, Ivan helps his clients launch products and create and execute advertising campaigns that match the clinical evidence they have for their products, paying close attention to the changing rules governing internet marketing, consumer testimonials and social media.
Ivan advocates for clients subject to the often overlapping jurisdictions of the U.S. Food and Drug Administration, the Federal Trade Commission, and the U.S. Consumer Product Safety Commission. When advertising disputes arise, he regularly represents companies before the National Advertising Division (NAD) and the Electronic Retailing Self-Regulation Program (ERSP). He has been included in Best Lawyers in America from 2007 – 2017.
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