The Federal Trade Commission (“FTC”) announced its settlement with NeuroMetrix, Inc. over allegations that the company made deceptive claims that its nerve stimulation device called Quell, which is to be worn just below the knee, treats pain throughout the body and is clinically proven and cleared by the Food and Drug Administration (“FDA”) to do so.

According to the FTC’s complaint, NeuroMetrix claimed that Quell was “clinically proven” and “FDA cleared” to provide “widespread relief of chronic and severe pain throughout the body” from the device’s fixed site application below the knee.

The FTC alleged that the company lacked scientific evidence to support its widespread chronic pain relief claims. Further, while the product was FDA-cleared to provide localized pain relief, it was not cleared for providing widespread relief of chronic or severe pain that is experienced beyond the site of application or that is due to specific health conditions, such as osteoarthritis, nerve damage, sciatica, shingles, and fibromyalgia.

In addition to barring the company’s deceptive claims, the FTC’s order imposes a $4 million judgment, which must be paid to the FTC within thirty days, and requires them to turn over up to an additional $4.5 million in future foreign licensing payments.

Takeaway: Advertisers of FDA-regulated products should be aware that there is joint-jurisdiction regarding advertising claims by both the FDA and the FTC.  As seen here, the FTC will assert its jurisdiction and impose fines against companies that claim their products perform beyond the scope of what is approved by the FDA.