Do you manufacture, import, or market personal hygiene and wellness devices sold in drugstores? If so, you may be focused on U.S. Food and Drug Administration (FDA) compliance, but may not have considered the requirements of another Federal regulatory agency: the Federal Communications Commission (FCC). Manufacturing, importing, and/or marketing non-compliant personal hygiene, wellness and similar devices may violate the FCC’s rules.
A prime example is the FCC’s proposed $590,380 fine last year against a company that marketed consumer grade electronic personal hygiene and wellness devices. The alleged violations? Marketing “non-compliant” ultrasonic humidifiers, sound machines, TENS stimulators, diffusers, and a manicure/pedicure set. In this case, the company apparently used contract manufactures to make devices that it then brought into the United States for sale. The FCC determined that more than a dozen products violated one or more FCC requirements. To compound these violations, the company apparently continued to market non-compliant products even after the FCC began its investigation.
What was FCC’s authority to act? The FCC is responsible for regulating the commercial use of our wireless airways. Generally, humidifiers and similar drugstore products would not fall under the FCC’s jurisdiction. However, ultrasonic products and other devices that contain electronic circuits may emit radio frequency. For this reason, they are considered “unintentional radiators” under the FCC’s regulations. Unintentional radiators must undergo compliance testing, must be given specific labeling, and must be marketed with certain user manual information, among other requirements.
So who is at risk? The impetus of the FCC’s investigation in the example case was a complaint filed with the Enforcement Bureau. In most instances, this is how the FCC discovers non-compliant behavior, and this often occurs when a competitor believes that it is being disadvantaged by another party’s lack of compliance with the FCC’s rules. Dissatisfied or terminated employees are another source of complaints to the FCC’s Enforcement Bureau.
A commonsense measure that may protect manufacturers, importers and retailers of items such as consumer personal hygiene and wellness devices is to have a compliance plan in place. Such a plan would clearly establish responsible employees, set out time frames for regular FCC compliance review, and require a rapid response to any investigation, among other features. A compliance plan also indicates that FCC compliance is being taken seriously, something that can mitigate against larger fines in the event of inadvertent non-compliance.