The $3 billion industry has increasingly drawn the attention of both regulators. Among the questions the FDA brought up in the request for comment involve consumer and health provider attitudes towards homeopathic products, requests for data sources regarding the safety of the products, and what kind of measures could be implemented to improve the clarity of the CPG’s standard, among others.
Photo courtesy of NPR/FDA
The Federal Trade Commission (FTC) commented publicly on Friday regarding proposed Food and Drug Administration (FDA) changes to its regulation of homeopathic products. The commenting period follows the FDA’s two-day public hearing in April, soliciting ideas for improvements upon longstanding policies towards homeopathic remedies that have remained unchanged since releasing the Compliance Policy Guide for homeopathic products (CPG) in 1988.The FTC’s comments also precede a workshop that agency has planned for September 21st. The FTC believes that the FDA’s current policy “may harm consumers and confuse advertisers.” The FTC cited a 2012 American Association of Poison Control Center annual report which referenced over 10,000 cases of incidents related to homeopathic products.
In a Friday press release, the FTC wrote that its main conflict is that the FDA’s guidelines clash with the FTC’s advertising substantiation policy, “which requires competent and reliable scientific evidence for health benefit claims.” According to the FDA’s CPG, the agency does not approve homeopathic medications or review them for safety and efficacy. The FDA does require homeopathic advertisers to list the product’s indications for use; however it does not require scientific evidence to back the indications. The FTC believes that the standard causes confusion, leading product marketers to believe that clearing the FDA hurdle means that the product clears the disparate FTC standard. The agency also wrote that consumers are also confused when homeopathic remedies are placed next to FDA-approved medications in stores. The FTC is requesting a change to this existing standard as well.
The $3 billion industry has increasingly drawn the attention of both regulators. Among the questions the FDA brought up in the request for comment involve consumer and health provider attitudes towards homeopathic products, requests for data sources regarding the safety of the products, and what kind of measures could be implemented to improve the clarity of the CPG’s standard, among others. The FTC is asking the FDA to either withdraw the CPG provisions entirely, or to eliminate the requirement for specific indications of use. Another option that the FTC listed was that the FDA could require credible scientific backing for any listed indication. Although the industry has existed for over 200 years and is growing in recent times, there is little scientific evidence to show that homeopathic remedies are clinically effective. A recent analysis of 170 different studies regarding the efficacy of the treatments led no conclusive scientific evidence supporting the remedies. September’s FTC workshop will focus on advertising over-the-counter homeopathic products, and ways to communicate the differences between these remedies and FDA-approved drugs.
Ad Law Access – Kristi Wolff
Regulatory Affairs Professional Society – Michael Mezher
Washington Examiner – Robert King