A company that marketed CBD-coated tampons to help relieve period pain has pulled the products from the U.S. market after receiving a formal warning from the Food and Drug Administration (FDA). The move followed a December 2024 FDA letter finding the tampons misbranded and adulterated medical devices because they contained cannabidiol (CBD) and were being sold without required pre-market authorization.
What the FDA said—and why it matters
In a December 17, 2024 warning letter, the FDA’s Center for Devices and Radiological Health (CDRH) told Anne’s Daye Ltd dba Tampon Innovations that its “CBD Daye Tampons” were medical devices under federal law and not cleared or approved for U.S. sale. FDA said the firm’s manufacturing and quality-system practices also failed to comply with device regulations, and emphasized that adding CBD to a tampon can raise safety and efficacy concerns, including potential local/systemic exposure to cannabinoids and contamination risks.
The agency’s notice highlighted two central problems:
- Regulatory status: Introducing CBD turned the product into a different device than any version FDA had previously cleared, meaning new premarket authorization would be required.
- Quality and labeling: FDA cited violations tied to quality-system regulation (QSR) and misbranding, including marketing claims that implied pain relief benefits without appropriate evidence or authorization.
These issues fit a broader pattern: FDA has repeatedly warned companies selling cannabis-derived products (CBD, delta-8 THC) that are unapproved, mislabeled, or make disease/therapeutic claims. The agency maintains a running list of such warning letters and enforcement actions.
The company’s response: pulling products and pausing subscriptions
Within weeks of the warning, the company told customers and media it would voluntarily remove CBD tampons from the U.S. market. Industry reporting on January 8, 2025 noted the pullback and quoted company messaging acknowledging the FDA’s concerns.
Regulatory records further show the firm canceled U.S. subscriptions tied to the CBD product. In a recall/resolution entry describing the action plan, customers were informed on February 17, 2025 that subscriptions would be canceled and a courtesy credit issued, reflecting a broader pause of U.S. CBD tampon sales after FDA’s notice. (FDA’s device database lists the action as a Class II recall entry, documenting the corrective steps and customer communication.)
Data points at a glance
- Dec. 17, 2024 — FDA issues warning letter to Anne’s Daye Ltd (Tampon Innovations) over CBD-coated tampons and a vaginal microbiome kit; cites misbranding, adulteration, and QSR violations.
- Jan. 2, 2025 — Coverage details FDA’s position that the CBD tampon is not approved for U.S. sale and currently misbranded.
- Jan. 8, 2025 — Company says it has pulled products from the U.S. market in response to the warning letter. READ MORE: Marijuana Moment
- Feb. 17, 2025 — Customers notified that subscriptions are canceled as part of the U.S. market pause; FDA device database captures the action as a Class II recall entry.
How a CBD tampon became a regulatory flashpoint
At the heart of FDA’s action is the intersection of women’s health devices and cannabis-derived ingredients. In the U.S., tampons are class II medical devices, and even modest changes can require new submissions if they raise new questions of safety or effectiveness. When CBD is added, FDA treats the product as a different device—with a different risk profile—triggering a need for premarket review (510(k) clearance or De Novo/PMAs depending on risk) and full quality-system compliance.
While some device iterations (e.g., sterilization process changes) can be cleared, incorporating an active pharmacologic substance like CBD effectively merges drug-like claims (pain relief) with a device, complicating regulatory status. That’s why FDA has also pursued CBD products for improper therapeutic claims in other categories, from edibles to animal health—underscoring that CBD remains an unapproved additive for most uses.
Trade and medical-device publications echoed FDA’s concerns, noting the lack of clinical evidence that intra-vaginal CBD provides safe, effective relief and citing theoretical risks such as reproductive toxicity, residue exposure, or contaminants (e.g., THC) depending on sourcing and controls.
What this means for consumers
- CBD tampons are off the U.S. market for now. If you previously bought CBD-coated tampons from this brand in the U.S., expect subscription cancellations and no new U.S. shipments while the company addresses FDA’s findings. Check the firm’s official channels for refunds/credits and disposal or return instructions, where applicable. READ MORE: FDA Access Data
- Standard (non-CBD) products are different. Some tampon models from the same company (e.g., non-CBD “nude” tampons) have had separate regulatory pathways. But once CBD is introduced, FDA treats the device as a new product requiring authorization. Always look for clear labeling and consult the FDA database if unsure. READ MORE: medicaldevice-network.com
- Be wary of therapeutic claims. The FDA continues to scrutinize any unapproved claims—especially pain relief, anti-inflammatory, or disease-related statements—made on websites, social media, or packaging. If a menstrual product promises drug-like benefits without FDA authorization, that’s a red flag.
Implications for femtech and cannabis brands
- Regulatory diligence is non-negotiable. Adding CBD to intimate-use devices moves a brand into a complex area of combination-product and device regulation. Companies should expect premarket review, robust biocompatibility data, stability, residuals, and process validation—plus stringent labeling controls to avoid implied drug claims.
- Marketing guardrails are tight. FDA has repeatedly used social media and website content as evidence in warning letters. Even engaging with consumer testimonials that mention pain relief can be cited. Compliance counsel should vet every claim and creative asset.
- This case will be cited widely. Expect regulators, retailers, and payment processors to reference this enforcement when assessing CBD-infused femtech or other body-contact products. The safest path is evidence-first, followed by formal submissions—not a “launch now, validate later” approach.
The bigger picture: FDA’s CBD stance isn’t softening
Despite broader normalization of cannabis at the state level, FDA continues to limit CBD’s legal uses and pursues companies that blur the line between supplements, foods, cosmetics, and unapproved drugs/devices. Its public tracker of cannabis-derived product warning letters shows consistent enforcement pressure—particularly where health claims or youth-appealing products are involved. For CBD in women’s health devices, expect regulators to demand premarket evidence of safety and benefit before allowing U.S. sales.
Bottom line
The FDA’s December 2024 warning to the maker of CBD-coated tampons set off a swift chain reaction: U.S. market withdrawal, subscription cancellations, and increased scrutiny of CBD-infused devices overall. For consumers, the message is straightforward—don’t expect CBD tampons at U.S. retailers until a manufacturer completes the required regulatory steps and can substantiate safety and efficacy. For brands, the case is a blueprint: in intimate-care categories, regulatory science comes first, and marketing claims must be tightly controlled to stay on the right side of FDA. WEBSITE: U.S. Food and Drug Administration
Note: Regulatory positions and company status can change. For the most current information, check FDA’s warning-letter page and device database before purchasing or marketing CBD-infused medical products. (U.S. Food and Drug Administration)