The makers of three types of head impact sensors survived a Federal Trade Commission (FTC) review into advertising claims for their products, with the agency closing out its investigation without taking action.
Section 5 of the FTC Act requires that advertising claims be truthful and nonmisleading, while Section 12 prohibits false advertisements for foods, drugs, devices, services or cosmetics. Health benefit claims in advertising require competent and reliable scientific evidence substantiating the claims prior to their dissemination.
Concerned that X2 Biosystems, MBTIsense and Prevent Biometrics failed to adequately substantiate their claims, the FTC launched an investigation.
X2 Biosystems marketed its X-Patch and X-Patch Pro impact sensors as able to measure the linear and rotational impacts to the head with accuracy, sensitivity and reproducibility, as well as accurately determine concussion risks and thereby reduce the incidence and risks of head impact injuries.
After taking a closer look at the matter (including nonpublic information), the FTC’s Division of Advertising Practices decided not to recommend enforcement action. The closing letter noted factors such as modifications to the advertising and marketing materials, the fact that X2 stopped selling the X-Patch and that it never sold the X-Patch Pro.
Similarly, MBTIsense faced an investigation into its ROSH sensor, which it touted as being able to accurately measure and record the magnitude and location of multiple impacts experienced throughout a game, and thereby warn users of potentially serious head injuries and allow users to avoid secondary impact syndrome.
Factors such as minimal sales and the company’s decision to cease operations led to the FTC’s decision to close the investigation.
Finally, Prevent Biometrics promoted its impact sensor mouthguard as capable of accurately measuring the linear and rotational forces, the location, and the direction of head impacts, and that it could filter out false positives and light impact in order to measure the true positive impacts and prevent concussions from going undetected.
As the product was not yet available for sale, and the company had substantiated some of the claims and had modified its advertising and marketing materials, the FTC closed its investigation.
To read the closing letter to X2, click here.
To read the closing letter to MBTIsense, click here.
To read the closing letter to Prevent Biometrics, click here.
Why it matters: The FTC’s interest in the health benefit claims made by the three manufacturers of head sensor impact products puts other companies on notice that the agency is keeping a close eye on such claims.