There will be a lot of fitness tech hitting shelves this year, and the FDA is on alert.
The department distributed a proposal this week laying out plans to regulate wearables and other general wellness products. The document is for comment purposes only, so there’s no need to toss that Fitbit and take the Apple Watch off your wishlist. The goal here is to make sure that people with certain ailments, diseases, and general fitness goals stay out of harm’s way. The word of the day is “risk.”
Low-Risk Wellness Products
Devices the department considers “low-risk” should all stay below the radar. Your smartwatch will still be allowed to count your steps and shame you out of a donut, but don’t expect to see claims of magic muscle-building Wi-Fi. Should the preliminary guidelines move forward, approved claims would be as follows:
Increasing and improving muscle size or body tone.
Assisting with healthy weight, healthy eating, or weight loss goals.
Promoting relaxation or managing stress.
Increasing, improving, or enhancing the flow of qi.
The line is simple: Wearables won’t be allowed to reference specific diseases or conditions. It works the other way too — the FDA doesn’t plan to sweat any lacks of labels or poorly made wristbands — safety is the main concern.
