The warning letter stems from a July 2024 inspection of the company’s facility in Bulgaria, where FDA Investigators uncovered several regulatory violations. The Daye Tampon had been cleared for use as a traditional tampon (to absorb menstrual discharge); however, 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 are not minor details — they are fundamental to protecting consumer health.
Adding to the controversy, the company’s packaging and promotional materials did not 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 that “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 is 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 are 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; however, when it comes to products that affect the human body, cutting corners is not just risky — it is reckless.
CBD tampons might sound like a revolutionary idea; however, until manufacturers put science before hype, FDA will remain anything but mellow.
REFERENCE: MD+DI (Medical Device and Diagnostic Industry); 13 JAN 2025; Amanda Pedersen