She also noted that the FTC acknowledges in its complaint that the FDA cleared Quell for use as a wearable transcutaneous electrical nerve stimulation device (TENS) device to relieve [localized] pain. She also noted that the Commission did not cite evidence in its complaint to support its argument that consumers interpreted the “FDA cleared” phrase to apply to the widespread pain relief claims in the company’s advertisements.
“In the midst of the opioid crisis, consumers are rightly seeking drug-free alternatives. Imposing on marketers a substantiation standard higher than needed to support advertising claims can chill the dissemination of useful information and thwart the efforts of consumers to find feasible alternatives to addictive prescription pain medicines,” said Commissioner Wilson.
