Here’s the rundown. On July 15th, the Food and Drug Administration (FDA) issued a letter to Whoop. The FDA criticized Whoop, a company known for its fitness tracker popular among top athletes, for rolling out its Blood Pressure Insights feature without appropriate regulatory approval.

In response, Whoop pulled out the W word: wellness.

In health and wearable tech, “wellness” often acts like a “get out of jail free” card. Advanced health functions such as EKGs and atrial fibrillation alerts need regulatory approval for consumer use, as they might be seen as diagnostic or influence medical decisions. In contrast, features like step counting and blood oxygen level tracking fall under wellness and don’t require FDA oversight. They’re aimed at encouraging healthy living by providing users with visual cues of their health metrics. These are deemed “just for fun.”

Whoop’s Blood Pressure Insights feature, however, lies in murkier territory.

Whoop’s feature operates by having users initially take readings with a conventional blood pressure cuff. Post-calibration, Whoop claims their tracker utilizes metrics like heart rate, heart rate variability, and blood flow patterns during sleep to estimate a user’s systolic and diastolic blood pressure each morning. The FDA argues that blood pressure estimation is not a low-risk feature and implies a diagnostic nature connected to hypo- or hypertension. Whoop responds by respectfully disagreeing, comparing the feature to tracking sleep respiratory rates and arguing that it allows them to swiftly introduce innovations to a larger audience under the wellness category.

Both Whoop and the FDA present valid arguments. A user might receive multiple “high” blood pressure readings, presume they have hypertension, and make health decisions based on that belief. However, it’s branded as a beta feature, and similar features without FDA regulation exist in the market. Numerous sleep trackers claim to monitor “breathing disturbances,” not marketed directly as sleep apnea detectors (which would require FDA approval), but there lies the semantics. The underlying motive is to alert users who might need to investigate potential sleep apnea.

The core issue is identifying which features pose high versus low risks of harm. Many situations are straightforward. For instance, Natural Cycles, a period tracking app, claims it can act as digital contraception using temperature data from wearables like the Oura Ring, obviously requiring regulatory review due to high stakes. Conversely, Samsung’s new Antioxidant Index on the Galaxy Watch 8, while assessing diet, is unlikely to harm health, even if prone to inaccuracies like distinguishing between fruits and a Cheez-It.

Where the FDA’s current process falls short is the increasing number of features that lie somewhere in the middle. Take the Oura Ring. A friend just asked me whether they should get one based on a TikTok video. In said video, celebrity DJ Dillon Francis says the main reason he has an Oura Ring is because it predicts when he’s getting sick. This is the Symptom Radar feature, which, in simple terms, flags when you might be getting sick — and it’s based on real clinical research conducted during the COVID-19 pandemic. It sounds diagnostic, which requires FDA clearance. But it’s not. It’s considered a wellness feature because it doesn’t tell you what you’re falling ill with — just that you might be showing “early signs of a health change.” And while there’s a distinct difference between a diagnosis and a heads-up, it can feel awfully similar to a layperson.

Also, Whoop isn’t the only company exploring blood pressure tech. Samsung has a similar feature that’s unavailable in the US, as it hasn’t been cleared by the FDA. According to Bloomberg, Apple has also been working on an Apple Watch feature that flags when your blood pressure spikes above your baseline, but it reportedly won’t spit out direct readings like a continuous glucose monitor would — possibly to avoid FDA clearance as a “wellness” feature.

Beyond blood pressure, Samsung and Apple are also widely rumored to be working on blood glucose monitoring features, where the stakes for diabetics could be sky-high. If or when those features do become available, it’s possible that companies will adjust how they work to more broadly fit under a wellness label. For instance, instead of glucose readings, you get a trend line or score. I’m skeptical of the average person being able to discern the nuance when even seasoned tech journalists sometimes struggle with the correct verbiage.

Maybe it seems silly to sound the alarm over semantics. But as politicians advocate for greater wearable adoption, the stakes have never been higher. In a better, ideal world, companies would abolish phrases like “clinically proven” or “medical grade” from marketing. The FDA would figure out a clearer framework for the design of a wellness feature versus a medical one. But we don’t live in an ideal world — and that means it’s up to the consumer to know the difference. Frankly, that’s not going so well. Perhaps that means it’s time we acknowledge that wellness isn’t an innocuous word anymore.