The FTC recently settled false advertising claims against Breathometer, Inc. regarding Breathometer’s breathalyzer app and wireless device. Among other allegations in its complaint (including false and unsubstantiated claims, false establishment claims, unfair practices, and consumer injury), the FTC alleged that Breathometer lacked the scientific evidence to back up its claims. Specifically, FTC alleged that Breathometer’s advertising claimed that the app and devices at issue were “law enforcement grade products” that were proven by “government-lab grade testing” to accurately measure a consumer’s blood alcohol content in real time. However, FTC alleged that the devices suffered from accuracy problems, namely, devices that had initially passed quality control checks could provide erroneous readings and a user could think she had a lower BAC limit than she actually had. Eventually it became clear that the sensors deteriorated significantly over time and that Breathometer had no reliable means of recalibrating the product in the field.

The resulting settlement order barred Breathometer and its founder/CEO from making accuracy claims about its breathalyzer product unless the claims were supported by rigorous testing and were substantiated by reliable and competent scientific evidence. According to the settlement order, such reliable and competent scientific evidence must be sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in the light of the entire body of relevant and reliable scientific evidence. In this case, competent and reliable scientific evidence required testing that demonstrated that the manufactured device met the accuracy specifications set for evidential breath alcohol tests that have been tested and approved by the Department of Transportation. Breathometer was also required to notify and pay full refunds to consumers who bought their devices.

TIP: An advertiser should have at least the advertised level of support for its claims. Claims such as “scientifically proven” or “tests prove” should be substantiated by competent and reliable scientific evidence that is relevant to the product advertised.