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2017 Trends in Marketing Communications Law

FTC/Regulatory and State >> FTC Renews Focus On Efficacy And Safety Claims

April 11, 2017

The Federal Trade Commission (FTC) has increased its enforcement efforts against marketers for failing to substantiate their efficacy and safety claims with competent and reliable evidence.

When evaluating claims about the efficacy and safety of foods, dietary supplements and drugs, the FTC typically has applied a substantiation standard of "competent and reliable evidence." The FTC has defined this standard as "tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by qualified persons and are generally accepted in the profession to yield accurate and reliable results" that are "sufficient in quality and quantity … when considered in light of the entire body of relevant and reliable scientific evidence…."

Early in 2016, the FTC settled with Lumosity over claims that its "brain training" program could delay cognitive decline and reduce cognitive impairment associated with various health conditions, and that scientific studies proved these benefits. The stipulated order required Lumosity to pay $2 million and to ensure that any future health claims were supported by competent and reliable scientific evidence. The FTC similarly found that an application developer had violated the FTC Act by falsely claiming that its app would improve users’ vision and reduce the need for glasses and contact lenses. Seeking to stem the exploitation of a public health crisis, the FTC sent warning letters last summer to ten online marketers selling Zika virus-protection products. The products included wristbands, patches, and stickers that purportedly could repel mosquitos that carried Zika or otherwise protect users from the virus. The FTC's letter noted that claims as to prevention of Zika infection had to be supported by well-controlled human clinical testing, using the species of mosquito that carried the Zika virus.

The FTC also recently unveiled an enforcement policy statement seeking to dispel misinformation about over-the-counter homeopathic drugs. According to the FTC, efficacy claims based on traditional homeopathic theories (dating back to the 1700s), rather than scientific evidence, likely were misleading. Although the FTC affirmed its commitment to enforcing the FTC Act in these cases, it also noted that these efficacy claims might not be misleading where accompanied by effective disclosures that there was no scientific evidence that the product worked and the product’s claims were based only on theories of homeopathy from the 1700s that were not accepted by most modern medical experts. Even then, however, the FTC expressed doubt that these disclosures would dispel express statements about the products’ efficacy.

Key Takeaways

  • The FTC has remained focused on enforcing the "competent and reliable" standard against marketers that promote healthcare products.
  • Claims must be tailored to the supporting substantiation, and cannot overstate a product's efficacy in treating a particular condition.
  • With the departure of Chairwoman Edith Ramirez, the Trump administration will have the opportunity to appoint three new commissioners to the FTC and reshape the FTC's enforcement priorities going forward.