The company has announced that it has pulled its CBD-coated period pain relief tampons from the U.S. marketplace after receiving a warning letter from the Food and Drug Administration.
FDA sent a letter to Anne’s Daye (the maker of Daye Tampons) in mid December, stating that the “adulterated tampons” are not allowed to be sold in the U.S.A. The agency stated that the issue had been raised with the company leadership in April.
The FDA said that although the products were approved for “insertion into the vagina in order to absorb menstrual fluids,” Daye had “failed to notify FDA of any changes or modifications made to the device which could have a significant impact on its safety or effectiveness.”
A representative from Anne’s Daye confirmed to MEDCAN24 Wednesday that they will no longer be selling their products in the U.S.
The company stated that “in light of this feedback, and given the sensitive regulatory environment surrounding cannabinoids used in medical devices in the U.S. we have decided to remove the CBD Daye Tampons voluntarily from the U.S. marketplace while we evaluate other pathways for regulatory compliance.” We are working closely with the FDA in order to clarify their concerns and any misunderstandings regarding our products’ status.
FDA refused to comment on this story. The agency said it would not weigh in on “an open compliance matter.”
A representative noted that, in general, FDA can issue a “warning letter close-out letter” acknowledging a company has taken corrective actions to address underlying violations, pointing to an FDA webpage about the process. The matter is still open for the time being.
The site states that “a close-out may be issued when, according to FDA’s evaluation of the firm, it has taken corrective actions in order to address the violations stated in the Warning Letter.” The site states that “a close-out letter won’t be issued on the basis of representations made by the company that they will take or have taken some action.” FDA must verify that the corrective measures have actually been taken. A follow-up audit is the usual standard for confirming that corrections were made.
FDA adds that “enforcement actions may be taken immediately” if it finds further violations in subsequent inspections or through other means.
In last month’s warning letter, FDA cited as possible risks “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).”
The FDA told the company that “despite FDA repeatedly identifying your product as being sold without the required premarket authorization,” “you continue to sell the device.”
The FDA’s letter to the company says that Valentina Milovova, the CEO of the company and its founder, replied in July to FDA earlier communication. It does not, however, include her reply.
Daye told MEDCAN24 that his company “operates under rigorous international standards and follows Good Manufacturing Practices for pharmaceuticals (GMP).”
“Daye also conducts continuous laboratory testing, controlled clinical trials and biocompatibility tests as per FDA regulations, along with post-market surveillance, to ensure that all products meet the highest standards for safety and performance,” said the company. “We go beyond the regulatory requirements and are proud of being the only brand that manufactures menstrual products according to the highest pharmaceutical and medical standards.”
The company has also clarified that CBD is “exclusively THC free” in their tampons and that “the products have undergone extensive clinical tests, including the full FDA Biocompatibility Testing Panel for Medical Devices, which includes subacute toxicity and chronic toxicity analyses.” The CBD Tampon did not show any toxicity.”
Daye’s answer to MEDCAN24 didn’t directly address the unauthorized products violations surrounding adding CBD to tampons, without FDA clearance, or claiming that the tampons reduce period pain. The company did no respond immediately to further questions.
While the FDA has not approved CBD tampons to be sold in the U.S.A., some evidence is emerging that CBD can relieve menstrual discomfort.
Daye CEO Milanova—to whom the new FDA warning letter was addressed—was the lead author on a study published in the Journal of Endometriosis and Uterine Disorders in late 2023 into the effects of CBD tampons on menstrual pain. It concluded that tampons infused with CBD “achieved statistically significant pain reduction” and could offer “fewer side effects than anti-inflammatories, while producing a similar pain-relieving effect.”
A randomized, control study that looked at pain levels 2 hours after application of a tampon found a “statistically significant reduction of pain” on the second day and first and second days in the third month. The CBD-infused tampon caused irritation in less than 5% of participants. Between 37 and 40% reported an improvement in vaginal dryness.
Vertigo was also reported by two patients while using the product. The study stated that “the events occurred rapidly and without the need for medical assistance after removal of CBD-tampon.”
FDA has issued a rash of warning letters to cannabinoid businesses since the legalization of hemp through the 2018 Farm Bill. The Federal Trade Commission and that agency have acted with discretion to take enforcement actions against businesses whose packaging, or claims of medical benefits, are particularly misleading.
While CBD was initially the focus of enforcement, recent actions have focused more on cannabinoids that are intoxicating such as delta-8-THC. Last summer, for example, FDA and FTC sent warning letters to several companies for allegedly marketing products containing delta-8 THC “in packaging deceptively similar to many foods children eat such as Froot Loops and Chips Ahoy! chocolate chip cookies.”
The agencies noted at the time that it was the second time they sent joint cease-and-desist letters to hemp companies over unapproved marketing of the cannabis products. The agencies contacted another set of companies about the “copycats” issue in July.
While bipartisan lawmakers have strongly criticized FDA’s decision to not enact regulation for hemp-derived CBD. This, they claim, is responsible for the economic slump.
Questions around how to free up hemp businesses to legally market products like CBD as dietary supplements or in the food supply have also come up in discussions around the next Farm Bill.
In the few years following its legalization, the hemp industry has faced unique regulatory challenges that stakeholders have blamed for the plummeting value of the crop. Despite the economic conditions, however, a recent report found that the hemp market in 2022 was larger than all state marijuana markets, and it roughly equaled sales for craft beer nationally.
Overall, the hemp market started to rebound in 2023 after suffering significant losses the prior year, the latest annual industry report from the U.S. Department of Agriculture (USDA) that was released in April found.
President-elect Donald Trump’s pick to lead FDA, meanwhile, is a medical marijuana skeptic, having promoted claims that cannabis use is linked to cardiovascular issues and mental health problems for youth. He also said that marijuana was a gateway drug.
As for CBD’s possible effects on pain, a scientific review published last April listed pain as one of a variety of ailments the cannabinoid could help manage, along with aspects of epilepsy, cancer, schizophrenia, diabetes and COVID-19, among others.
The National Football League also announced last year a partnership with Canadian researchers on a clinical trial to test the safety and efficacy of CBD for pain management and neuroprotection from concussions.
In 2023, meanwhile, researchers at Rutgers University and the University of Texas published research indicating that CBD may alleviate acute dental pain and may provide an equally effective but far safer alternative to opioids.
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