WARNING LETTER

Anne’s Daye Ltd dba Tampon Innovations MARCS-CMS 696362 — December 17, 2024

Delivery Method:: VIA UNITED PARCEL SERVICE
Product:: Medical Devices

Recipient:: Recipient Name

Valentina Milanova; Recipient Title

Founder & CEO; Anne’s Daye Ltd dba Tampon Innovations; The Biscuit Factory, 100 Drummond Road
Bermondsey
London
SE16 4DG
United Kingdom

Issuing Office:: Center for Devices and Radiological Health; United States

December 17, 2024

WARNING LETTER
CMS # 696362

Dear Valentina Milanova:

During an inspection of your firm located in Oblast Sofia Grad, Bulgaria on July 8, 2024, through July 11, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Cannabinoid (CBD) coated tampons (“CBD Daye Tampons”) and vaginal microbiome screening kits. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

We received a response from Valentina Milanova, Founder and CEO, dated July 30, 2024, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We have also previously received additional correspondence from your firm related to marketing authorization requirements for your products. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

UNAPPROVED DEVICE VIOLATIONS

1. Our inspection and review of your website (www.yourdaye.com) determined that the CBD Daye Tampon is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device. The CBD Daye Tampon is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii). The device is further misbranded because your firm did not notify FDA regarding changes and modifications in the device that could significantly affect the safety or effectiveness of the device, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(i).

Specifically, the Daye Tampon was cleared under K223883 with the following indications “The Daye Tampons are indicated for insertion into the vagina to absorb menstrual discharge.” However, 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. Examples include:

• Images of your package label and other statements on the Walmart Web Site at: https://www.walmart.com/ip/Daye-Mixed-Pack-Tampons-Sugarcane-Applicator-No-Shed-Sleeve-Ocean-Safe-Flushable-Wrapper-100-Organic-Cotton-9-Comfort-Coated-Super-Absorbency-18-Coun/5551535956?classType=REGULARhttps
o “CBD is known for its soothing and anti-inflammatory properties, which makes it your period’s perfect partner in crime.”
o “…, each featuring a special comfort coating that ensures a mellow period experience.”

• Trustpilot Web Site: https://www.trustpilot.com/review/yourdaye.com
o “We're really sorry to hear that the CBD tampons didn’t work for you. Research shows that different bodies have different responses to CBD, and just as other forms of pain relief, annoyingly it won’t work for everyone.”

• YourDaye Web Site: https://www.yourdaye.com/products/organic-cbd-tampons/
o “Fully-sustainable organic tampons with a no-shed protective sleeve and a CBD coating for the days when period pain is cramping your style.”

• Interview of your CEO: https://therecursive.com/breaking-feminine-health-taboos-the-startup-story-of-daye-and-their-cbd-tampons/
o “She found it interesting that industrial hemp has two main properties - its extracts act as a pain reliever while its fiber is super absorbent. These two properties stuck in my mind and as you can tell, that is how the idea of our pain-relieving tampon was born,’ Valentina says.”

Additionally, as noted above, and as you were advised in the It Has Come to Our Attention (IHCTOA) Letter of April 5, 2024, the CBD coating raises significant concerns regarding the safety and effectiveness of your device. The letter addressed FDA’s having previously notified you in our written feedback to pre-submission Q200187 that “the inclusion of a drug product (CBD) as part of the subject device (tampon) represents a different technological characteristic and raises different questions of safety and effectiveness as compared to the proposed predicate devices and other previously cleared tampons. Therefore, the 510(k) pathway is not appropriate for your product.”

As a related matter, FDA evaluated the regulatory decision form that you provided the investigator to support not needing a 510(k) for the CBD Coated Daye Tampons and found the assessment was inadequate because the CBD coating raises significant concerns regarding safety and effectiveness of the devices due to 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, you continue to market the device. Your firm currently imports Cannabidiol (CBD) Coated Daye Tampons into the United States under K223883. As we have communicated to you, the K223883 clearance is for only the Daye Tampon and not for a CBD coated Daye Tampon.

Please provide copies of all labeling and advertisements for the CBD Coated Daye Tampons.

2. Our inspection and review of your website (www.yourdaye.com) determined that the Vaginal Microbiome Screening Kit is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device. The Vaginal Microbiome Screening Kit is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

Your firm’s promotion of the Vaginal Microbiome Screening Kit provides evidence that the device is intended for diagnosing yeast infections, BV, STIs, fertility implications, and other gynecological health complications, indications for which your firm lacks clearance or approval. Examples include your company’s materials shown on:

• Your Web Site: https://www.yourdaye.com/products/vaginal-testing/
o “Understand your risk of vaginal infections like yeast infection or BV, STIs, fertility implications, and other gynecological health complications using a non-invasive at-home tampon test.”
o “Understand if you are at a higher risk for STIs and UTIs”
o “Detect bacteria that can cause vaginal infections like thrush & BV” via

• Trustpilot Web Site: https://www.trustpilot.com/review/yourdaye.com
o “Our diagnostic tool enables improved accuracy compared to traditional methods, increasing the sensitivity and specificity of existing diagnostic assays.”
o “For anyone who tests positive for STIs or HPV, we always provide a free consultation with our nurses to ensure they get the support they need.”

• Amazon Web Site: https://www.amazon.com/stores/Daye
o “Detect bacteria that cause vaginal infections like yeast infections & BV, understand your risk of contracting STIs and UTIs, check for microbes that affect your fertility using a non-invasive at-home tampon screen.”
o “Daye Tampons take highly accurate samples & allow for comfortable, at-home testing, complete with an applicator designed for pain-free and smooth insertion.”
o “Daye Microbiome Screening tests for bacteria and pathogens such as lactobacilli, bacterial vaginosis, candida, mycoplasma & ureaplasma.”
o “Getting screened with us means never having to face dead-end results as we offer specialist aftercare, tailored to you. Get personalized lifestyle hacks based on your results to boost your health as well.”
o “Screen the population of good and bad bacteria in your microflora with an increased diagnostic accuracy. Understand what's actually causing your symptoms.”
o “Tampons take better, more accurate samples then a standard swab”.

You have been importing and distributing Vaginal Microbiome Screening Kits into interstate commerce under K223883, which did not include a clearance for diagnostic purposes for the Daye tampons. The FDA evaluated the regulatory decision form you provided to the investigator to support that the Vaginal Microbiome Screening Kit is a general wellness device. However, the FDA has determined that your assessment is inadequate because your firm markets the device with diagnostic claims that are outside the scope of a general wellness device as described in the FDA guidance document “General Wellness: Policy for Low Risk Devices” at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices; and therefore, your device would need to be submitted for premarket review by the FDA.

For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for these devices is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

In addition, we offer the following comment:

During our inspection, FDA determined that your firm failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required 21 CFR 820.198(a). Complaints related to the addition of CBD to Daye Tampons that were listed in Trustpilot or third party systems were given responses by your firm, but not logged and evaluated appropriately in your complaint handling system. The complaints indicate CBD Daye Tampons may have an impact on the patients’ health (e.g. CBD drug interactions) that exceed the expected risks associated with regular (non-CBD) tampons.

Given the serious nature of the violations of the Act, the CBD Daye Tampons and Vaginal Microbiome Screening Kits manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are addressed. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and address the violations described in this letter. We will notify you regarding the adequacy of your firm’s responses and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent by email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to Food and Drug Administration, Center for Devices and Radiological Health, Office of Regulatory Programs, Division of Regulatory Programs 2: Establishment Support, Regulatory Inspections and Audits Team, White Oak Building 66, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS # 696362 when replying. If you have any questions about the contents of this letter, please contact: Jason Roberts at (240) 402-6400 or jason.roberts@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely yours,
/S/

Michael J. Hoffmann
Office Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

CC:
Valentina Milanova
Tampon Innovations
Nadezhda Dist, Bulevard Rozhen 41a
Iliyantsi, Oblast Sofia Grad, 1271 Bulgaria

David Lennarz
Registrar Corp
144 Research Drive
Hampton, VA US 23666
Phone: (757) 224-0177
Email: david.lennarz@registrarcorp.com