Carrot gains FDA approval for new OTC smoking cessation tool

REDWOOD CITY, Calif. — Carrot on Monday announced that its Carbon Monoxide Breath Sensor System has been cleared by the U.S. Food and Drug Administration for over-the-counter commercial use in smoking cessation programs.

"Smoking is the No. 1 cause of preventable illness and death worldwide," stated David Utley, CEO of Carrot, a digital health company with a mission to engage and empower millions of people to quit smoking. "While there has been a torrent of wearable tech to facilitate behavior change in fitness, weight loss and other targets, there's been no such innovation to help people quit smoking. So, we've designed a home-use mobile breath sensor device to help people who smoke cigarettes learn about their smoking behavior, and to use this information to help them in smoking cessation programs."

The Bluetooth-enabled mobile device, which pairs to a breath sensor application on a smartphone, measures carbon monoxide in exhaled breath to inform the user about how breath carbon monoxide levels are affected by smoking behavior. As with fitness wearables for tracking metrics like steps and sleep, the breath sensor enables a user to track the real-time effects of their smoking behavior.

Carrot's announcement of FDA 510(k) clearance of its OTC breath sensor coincides with the launch of Pivot, Carrot's new smoking cessation program, delivered as a mobile medical application via a smartphone. Pivot, which offers evidence-based motivational, educational and coaching tools, will initially be offered through self-insured U.S. employers to promote healthy workplaces and to reduce lost productivity and excess healthcare costs associated with smoking.

"Despite the fact that 70% of smokers say they want to quit, less than 7% of eligible smokers sign up for workplace cessation programs – even when they're free," commented Heather Patrick, VP behavioral science at Carrot. "Part of the reason for that is that most programs start with setting a quit date, then go straight to creating a quit plan. That's intimidating. So, Pivot has entirely reimagined smoking cessation, first by designing a program that is for all smokers, not just those ready to quit. And, second, by delivering evidence-based behavioral science strategies directly to the participant via their smartphone. Pivot is designed to appeal to and help smokers no matter where they are in their quit journey."

Smoking remains the leading cause of preventable illness and death in the U.S., where 40 million people smoke and nearly 500,000 die every year from smoking-related illness. Smoking is an enormous drag on the U.S. economy, with more than $300 billion in related healthcare costs and lost productivity annually.