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"CBD is known for its soothing and anti-inflammatory properties, which makes it your period's perfect partner in crime."

"... a CBD coating for the days when period pain is cramping your style."

These are a few examples of the way Anne's Daye Ltd., dba Tampon Innovations, a U.K. firm with a manufacturing plant in Bulgaria, marketed tampons infused with cannabinoids to American customers.

While menstruation can be annoying or even painful, selling tampons to U.S. consumers containing unauthorized substances like CBD is not a good solution, the FDA said.

The agency recently to the company's CEO, Valentina Milanova, noting that an inspection of the Bulgarian plant last July "determined that your firm manufactures cannabinoid (CBD)-coated tampons ('CBD Daye Tampons')."

Daye tampons are cleared for insertion into the vagina to absorb menstrual discharge. "However, your firm's labeling and promotion of the device provides evidence that the device is intended for relief of period-related pain, which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval," the FDA wrote.

"Our inspection and review of your determined that the CBD Daye Tampon is adulterated ... because your firm does not have an approved application for premarket approval ... or an approved application for an investigational device exemption," said the letter, which was signed by Michael Hoffmann, director of the FDA's Office of GastroRenal, ObGyn, General Hospital, and Urology Devices.

"The CBD Daye Tampon is also misbranded ... because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA," the letter continued. "The device is further misbranded because your firm did not notify FDA regarding changes and modifications in the device that could significantly affect the safety or effectiveness of the device."

The warning letter discussed a series of back-and-forth communications between the company and the FDA.

"FDA evaluated the regulatory decision form that you provided the investigator to support not needing a 510(k) for the CBD Coated Daye Tampons and found the assessment was inadequate because the CBD coating raises significant concerns regarding safety and effectiveness of the devices due to the potential for local and systemic exposure of CBD, potential adverse events (e.g., reproductive/developmental toxicity) associated with CBD, and potential effects due to the uncertainty of the potency and quality of the CBD (e.g., psychoactive effects from possible contaminants like Delta-9-tetrahydrocannabinol)," it said.

Daye appears to have heeded the FDA's warning. A visitor to the company website on Friday was asked what country they were browsing from, and upon answering "United States," was directed to a product list that did not include CBD-infused tampons. A page for the tampons on Walmart's website also has disappeared.

In an email to 麻豆传媒, Milanova said that the company is "actively working with the FDA to address their concerns and clarify any misunderstandings about our products' regulatory status. In light of this feedback and given the sensitive regulatory landscape surrounding cannabinoids in medical devices within the U.S., we have made the decision to voluntarily remove the CBD Daye Tampons from the U.S. market while we evaluate alternative pathways for regulatory compliance. We remain committed to ensuring that all of our products meet or exceed applicable safety and efficacy standards."

The tampons, however, were not the only Daye product the FDA had an issue with. Agency officials also warned the company against marketing its vaginal microbiome screening kit to U.S. customers.

"Our inspection and review of your website determined that the Vaginal Microbiome Screening Kit is adulterated ... because your firm does not have an approved application for premarket approval ... or an approved application for an investigational device exemption," the FDA said in its warning letter.

The kit is also misbranded because "your firm did not notify the agency of its intent to introduce the device into commercial distribution," the letter continued. "Your firm's promotion of the Vaginal Microbiome Screening Kit provides evidence that the device is intended for diagnosing yeast infections, BV [bacterial vaginosis], STIs [sexually transmitted infections], fertility implications, and other gynecological health complications, indications for which your firm lacks clearance or approval."

"The FDA evaluated the regulatory decision form you provided to the investigator to support that the Vaginal Microbiome Screening Kit is a general wellness device," it said, adding that the company's reasoning was inadequate "because your firm markets the device with diagnostic claims that are outside the scope of a general wellness device as described in the FDA guidance document ';' therefore, your device would need to be submitted for premarket review by the FDA."

The company appears to have partially heeded the FDA's warning on the test kit. A listing for that product on Amazon's website -- which the agency specifically complained about in its letter -- has disappeared. However, the product is for U.S. consumers at a price of $125, along with an offer of a 30-minute "sexual and reproductive coach consultation" for $55.

In her email, Milanova said that Daye's Vaginal Microbiome Screening Kits have been validated for accuracy and reliability through randomized controlled clinical trials "and are processed in a CLIA- and CAP-certified lab." She added, "As part of our commitment to regulatory compliance, Daye has worked closely with leading regulatory consultants who advised us that our existing 510(k) clearance and robust clinical evidence would provide a strong foundation for entering the U.S. market. We remain confident in the quality of our products and will continue collaborating with experts to ensure full compliance with FDA requirements."

This story was updated to include comments from Daye CEO Valentina Milanova.

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