On the heels of a Food and Drug Administration (FDA) warning letter to the manufacturer of CBD-coated tampons marketed to relieve period pain, the company says it has pulled the products off the U.S. market.
FDA had written to the company, Anne’s Daye, maker of Daye tampons, in mid-December, asserting that the “adulterated” tampons are not approved for sale in the U.S. and are being “misbranded” due to the addition of the cannabinoid. The agency said at the time that it had previously raised the issue with company leadership last April.
Although FDA cleared the company’s products “for insertion into the vagina to absorb menstrual discharge,” the agency said, Daye “did not notify FDA regarding changes and modifications in the device that could significantly affect the safety or effectiveness of the device.”
On Wednesday, a representative for Anne’s Daye told Marijuana Moment that the company will no longer sell the products in the U.S.
“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,” the company said. “We are actively working with the FDA to address their concerns and clarify any misunderstandings about our products’ regulatory status.”
FDA declined to comment for this story, saying the agency won’t 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. But for now, the matter remains open.
“A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter,” the site says. “A close-out letter will not be issued based on representations that some action will or has been taken. The corrective actions must actually have been made and verified by FDA. Usually, the standard for verifying that corrections have been implemented will be a follow-up inspection.”
If FDA identifies further violations through subsequent inspections or other means, it adds, “enforcement action may be taken without further notice.”
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).”
“Although FDA has repeatedly identified your product as being marketed without the necessary premarket authorization,” the agency told the company, “you continue to market the device.”
In July, company founder and CEO Valentina Milanova responded to FDA’s earlier communication, the agency’s new letter says, though it does not include the executive’s reply.
Daye emphasized to Marijuana Moment this week that the company operates “under rigorous international standards” and “follows Good Manufacturing Practices (GMP) for pharmaceuticals.”
“Additionally, all Daye products undergo continuous laboratory testing, randomized controlled clinical trials, biocompatibility testing as per FDA requirements, and post-market surveillance to ensure they meet the highest benchmarks for safety and performance,” the company said. “We regularly go over and above regulatory requirements, and we are proud to be the only tampon brand to manufacture menstrual products to the highest medical device and pharmaceutical standards.”
The company also clarified that the CBD in its tampons “is exclusively THC-free” and that the products “have undergone extensive clinical testing, including the full FDA biocompatibility testing panel for medical devices, which features subacute and chronic toxicity analysis. Toxicity was not identified in the CBD Tampon.”
Daye’s response to Marijuana Moment did not, however, directly address the unauthorized product violations around adding CBD to tampons without FDA clearance or claiming the tampons relieve period pain. The company didn’t immediately reply to follow-up questions.
To be clear, while FDA has not approved the CBD tampons for sale in the U.S., there is some emerging evidence that CBD may relieve menstrual pain.
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.”
Looking at a percentage change in pain 2 hours after tampon application, the randomized, placebo-controlled study found “a statistically significant reduction in pain on the second day of the first month, and the first and second days of the third month, attributable to the CBD-infused tampon.” Less than 5 percent of participants, meanwhile, experienced irritation related to the CBD-infused tampon, while between 37 percent and 40 percent reported “improvement in the level of vaginal dryness.”
Two patients also reported experiencing vertigo while using product. “The events elapsed rapidly without need for medical attention after removal of the CBD-tampon,” the study said.
FDA has issued a rash of warning letters to cannabinoid businesses since the legalization of hemp through the 2018 Farm Bill. For the most part, that agency and the Federal Trade Commission (FTC) have exercised discretion in taking enforcement action against businesses targeting those whose packaging or claims about medical benefits are especially misleading.
While CBD was a chief target early on, more recent enforcement actions have emphasized intoxicating cannabinoids 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. They made contact with another set of businesses about the “copycat” issue last July.
Meanwhile, bipartisan lawmakers and industry stakeholders have sharply criticized FDA for declining to enact regulations for hemp-derived CBD, which they say is largely responsible for the economic stagnation.
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.
The hemp industry continues to face unique regulatory hurdles that stakeholders blame for the crop’s value plummeting in the short years since its legalization. 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 has also suggested that marijuana is 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.
Photo courtesy of Chris Wallis // Side Pocket Images.
On the heels of a Food and Drug Administration (FDA) warning letter to the manufacturer of CBD-coated tampons marketed to relieve period pain, the company says it has pulled the products off the U.S. market. FDA had written to the company, Anne’s Daye, maker of Daye tampons, in mid-December, asserting that the “adulterated” tampons are Read More
