CBD Tampons Cramp FDA's StyleCBD Tampons Cramp FDA's Style

This week in Pedersen's POV, our senior editor opines on CBD-coated tampons that recently provoked FDA.

Amanda Pedersen

January 13, 2025

2 Min Read
Graphic featuring the author's headshot (MD+DI Senior Editor Amanda Pedersen) and a pull-quote from the article
Pedersen's POV is a weekly opinion column that addresses various aspects of the medtech industry, including the good, the bad, and the controversial.

CBD products truly are everywhere these days. From gummies to topical creams and now tampons, it seems there’s no limit to where this trendy compound might appear. But a recent FDA warning letter to Anne's Daye (dba Tampon Innovations) serves as a blunt reminder to medical device manufacturers: you can't just lace your products with CBD and expect FDA to be mellow about it.

The warning letter stems from a July 2024 inspection of the company’s facility in Bulgaria, where investigators uncovered several regulatory violations. The Daye Tampon had been cleared for use as a traditional tampon (to absorb menstrual discharge), but the company’s marketing and labeling promoted an additional use—relieving period-related pain due to its CBD coating. This, according to FDA, represents a significant change to the product’s intended use and required additional regulatory approval that the company failed to obtain.

FDA’s concerns about the product go beyond bureaucratic red tape. The inclusion of CBD in tampons raises serious safety and efficacy questions. According to the agency, the CBD coating could lead to potential risks such as local and systemic exposure to CBD, possible contaminants like THC, and adverse events related to reproductive or developmental toxicity. These aren’t minor details—they’re fundamental to protecting consumer health.

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Adding to the controversy, the company’s packaging and promotional materials didn’t shy away from bold claims. Statements like “CBD is known for its soothing and anti-inflammatory properties, which makes it your period’s perfect partner in crime” and “a special comfort coating that ensures a mellow period experience” painted the tampons as a pain-relief solution. The company even acknowledged the variability in CBD’s effectiveness in an online response to a negative review, stating: “Research shows that different bodies have different responses to CBD, and just as other forms of pain relief, annoyingly, it won’t work for everyone.”

And that’s exactly the point. Claims about pain relief should be backed by rigorous studies demonstrating both safety and effectiveness. By sidestepping the proper premarket approval process, Anne’s Daye put its product on the U.S. market without giving consumers the assurance that these tampons work as promised—or that they’re even safe to use.

This case underscores an important lesson for all medical device manufacturers: significant modifications to a device’s intended use require thorough vetting through the appropriate FDA channels. The “move fast and innovate” approach might work in Silicon Valley, but when it comes to products that affect the human body, cutting corners isn’t just risky—it’s reckless.

Related:Inspire Medical Is Under Fire from the DOJ

CBD tampons might sound like a revolutionary idea, but until manufacturers put science before hype, FDA will remain anything but mellow.

About the Author

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

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