Antitrust Law Daily Wrap Up, ADVERTISING NEWS: FTC staff urges FDA to reevaluate current policy on homeopathic products, (Aug 21, 2015)

By Michael Menzhuber, J.D., LL.M.

In a comment submitted to the U.S. Food and Drug Administration (FDA), the FTC staff asks the FDA to consider amending or repealing its regulatory framework for homeopathic medications that may appear to conflict with the FTC’s advertising substantiation doctrine in ways that could harm consumers and cause confusion for advertisers. The comment was submitted today in response to an FDA request for public comment in connection with an April 2015 FDA hearing on this issue.

The staff notes that the FDA’s regulatory framework for homeopathic drugs, set forth in a 1988 Compliance Policy Guide, does not require that over-the-counter (OTC) homeopathic drugs be approved by FDA as safe and effective if they satisfy certain conditions, including that the product’s label contains an indication for use. However, the policy guide does not require sellers to have competent and reliable scientific evidence to support the indication for use. Given the FTC’s long-standing advertising substantiation policy that health claims must be substantiated by such evidence, there is a concern that the FDA’s current regulatory framework may harm consumers and confuse advertisers.

The staff cautions that the FDA’s current framework may lead some companies to skirt more stringent regulations for OTC drug products or dietary supplements simply by labeling them as homeopathic or combining homeopathic ingredients with dietary supplements or other non-homeopathic ingredients. This concern arises out of the mistaken belief by some advertisers that homeopathic products that are in compliance with the FDA policy guide do not have to comply with FTC advertising substantiation requirements.

Finally, the staff asks that the FDA take into consideration research findings by the FTC’s Division of Advertising Practices if it decides to amend or repeal its homeopathic policy guide in the future. This research suggests that most consumers do not understand homeopathy, how the FDA regulates homeopathic drugs, or the level of scientific evidence needed to support health claims for homeopathic products.

The FTC is hosting a workshop on homeopathic drug advertising in Washington, DC, on September 21, 2015.

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