FDA Warns CBD Tampon Company Over Allegedly ‘Misbranded’ And ‘Adulterated’ Products
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The Food and Drug Administration (FDA) is warning the manufacturer of a CBD tampon that its allegedly “adulterated” product is not approved for sale in the U.S. and is currently being “misbranded” due to the addition of the cannabinoid.
Daye tampons, from the company Anne’s Daye, were cleared by FDA “for insertion into the vagina to absorb menstrual discharge,” the agency said in a warning letter last month. But it asserts that the company “did not notify FDA regarding changes and modifications in the device that could significantly affect the safety or effectiveness of the device.”
“As we have communicated to you,” the new December 17 letter says, the company’s FDA “clearance is for only the Daye Tampon and not for a CBD coated Daye Tampon.”
CBD Can Help Treat Pain, Cancer, Schizophrenia, COVID And Other Conditions
A new scientific review highlights CBD’s potential to treat various conditions such as epilepsy, pain, cancer, schizophrenia, diabetes, and COVID-19.
The review aims to summarize cannabis’s impact on human health, noting its “neuroprotective, anti-inflammatory, and pain-relieving properties”.
The study delves into CBD’s pharmacological properties, mechanisms of action, and its potential medical applications.
It discusses CBD’s role in treating epilepsy, pain relief, managing schizophrenia symptoms, and its potential as a COVID-19 inhibitor.
The review also touches upon CBD’s promising anticancer properties and its effects on diabetes-related processes.
“Cannabis exhibits neuroprotective, anti-inflammatory, anti-thrombotic, anti-bacterial, analgesic, and antiepileptic properties.”
Additionally, it acknowledges the industrial applications of CBD and hemp in pharmaceuticals, skincare, fuel, paper, clothing, rope, and massage oil production.
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Officials also pointed to marketing claims around the CBD tampons that it said go beyond what FDA had approved. “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 letter says.
It points to claims on the company’s website and elsewhere such as: “Fully-sustainable organic tampons with a no-shed protective sleeve and a CBD coating for the days when period pain is cramping your style.” And it quotes from a 2022 interview in which the company’s CEO refers to the product as “our pain-relieving tampon.”
Anne’s Daye did not immediately respond to a request for comment from Marijuana Moment.
An FDA representative said in an email that because the letter deals with an open compliance issue, “the FDA will not state its intentions regarding Anne’s Daye CBD tampons.”
In the letter, the agency said it previously raised the issues with Anne’s Daye in April, adding that “the CBD coating raises significant concerns regarding the safety and effectiveness of your device.”
The new letter cites 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.
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.
This story has been updated with a comment from FDA.
Photo courtesy of Kimzy Nanney.
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