The Food and Drug Administration (FDA) has issued a stern warning to Anne’s Daye, the company behind CBD-coated tampons, citing concerns about safety, effectiveness, and regulatory compliance. The agency contends the product is “misbranded” and “adulterated,” as it lacks the necessary FDA clearance for sale in the U.S.
FDA’s Core Concern: Lack of Approval for CBD-Coated Tampons
According to the FDA, the original Daye tampons received clearance to absorb menstrual discharge. However, the addition of a CBD coating introduces a significant modification that was neither communicated to nor approved by the agency. The FDA’s warning letter dated December 17 highlights that these changes could affect the product’s safety and effectiveness.
The letter also criticizes the company’s marketing claims, which suggest the CBD tampons provide pain relief. For example, promotional materials describe the product as “our pain-relieving tampon” and tout its ability to help with “period pain.” These claims, according to the FDA, alter the product’s intended use and demand additional regulatory review.
Safety Concerns Surrounding CBD Tampons
Beyond regulatory issues, the FDA raised safety concerns regarding the use of CBD in menstrual products. The agency flagged potential risks, including:
- Local and systemic exposure to CBD.
- Possible adverse effects, such as reproductive or developmental toxicity.
- Uncertainty about potency and quality, including potential contaminants like THC.
Anne’s Daye has yet to comment on the FDA’s warning. However, the company previously responded to a similar communication in July, though details of their reply were not disclosed.
Research Brings Both Hope and Scrutiny
Anne’s Daye founder Valentina Milanova co-authored a 2023 study on the effects of CBD tampons, published in the Journal of Endometriosis and Uterine Disorders. The research found that CBD-infused tampons provided statistically significant pain relief for menstrual discomfort.
Key findings from the study include:
- Pain reduction was most notable on specific days of menstrual cycles.
- Less than 5% of participants reported irritation from CBD tampons.
- 37% to 40% experienced improved vaginal dryness.
- Two participants reported brief vertigo that resolved quickly after removing the tampons.
While the study suggested fewer side effects compared to anti-inflammatory medications, it also underscored the need for further investigation into long-term safety and efficacy.
Broader FDA Crackdown on Cannabinoid Products
The FDA’s warning to Anne’s Daye is part of a larger effort to regulate cannabinoid-infused products. Since the 2018 Farm Bill legalized hemp, the agency has targeted businesses that market CBD and THC products with unproven medical claims or misleading packaging.
In recent years, enforcement actions have increasingly focused on intoxicating cannabinoids like delta-8 THC. Last summer, the FDA and FTC issued warnings to companies selling delta-8 THC products in packaging that mimicked popular snacks like Froot Loops and Chips Ahoy!, raising concerns about child safety.
What’s Next for Anne’s Daye?
The FDA has not disclosed its next steps regarding the CBD tampon issue, citing an ongoing compliance investigation. However, the warning letter makes it clear: Anne’s Daye must halt marketing its CBD-coated tampons until it secures appropriate regulatory approvals. Failure to comply could result in stricter enforcement actions, including product recalls or financial penalties.
