The Federal Trade Commission (“FTC”) recently released an enforcement policy statement regarding marketing claims for products in the over-the-counter (“OTC”) homeopathic drug market. Long permitted to fly under the FTC’s radar based upon a 1988 Food and Drug Administration (“FDA”) compliance policy guideline, OTC homeopathic drug advertising is now officially subject to general truth and substantiation requirements.

How does the FTC propose to enforce OTC homeopathic drug advertising rules?

The FTC has concluded that when it comes to potentially misleading consumers, it views OTC homeopathic drug advertising no differently than other drug and product advertising. As such, the agency now appears intent on reversing decades-long precedent of not challenging health-related claims for OTC homeopathic products that otherwise may have fallen short of being either truthful or substantiated. In addition, in recognition of the fact that substantiation through competent and reliable scientific evidence may not be possible for homeopathic drugs, the FTC has determined that compliance with its rules regarding health-benefit claims may be accomplished by communicating to consumers that:

  1. There is no scientific evidence that the subject product works; and
  2. The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.

Avoiding Deceptive Homeopathic Drug Advertising-Related Liability

As we have previously blogged, federal authorities and state attorneys general alike have been active in investigating and prosecuting companies for deceptive advertising practices. As the FTC’s new policy statement evidences, the agency appears prepared to extend its regulatory reach to homeopathic drug advertising. Accordingly, those businesses operating in the homeopathy space would be wise to remain vigilant in the promotion of their products to ensure compliance with applicable health benefit claim-related regulations, including working closely with experienced marketing counsel before the launch of any campaign.