The US Food & Drug Administration (FDA) has slammed a UK company for “adulterating” its products, sending it a warning letter for selling tampons containing unauthorised substances like CBD.
Anne’s Daye Ltd, trading as Tampon Innovations – a UK firm with a manufacturing plant in Bulgaria – was marketing tampons infused with cannabinoids to American customers.
Sales pitches like “CBD is known for its soothing and anti-inflammatory properties, making it your period’s perfect partner in crime”, and “… a CBD coating for the days when period pain is cramping your style”, constituted modifications to the products’ intended use, warned the FDA in its letter to the company’s CEO, Valentina Milanova.
The agency noted that an inspection of the Bulgarian plant last July “determined that your firm manufactures cannabinoid-coated tampons (‘CBD Daye Tampons’)”.
Daye tampons are cleared for insertion … to absorb menstrual discharge. “However, your labelling and promotion provide evidence that the device is intended for relief of period-related pain, which would constitute a major change … to its intended use, for which your firm lacks clearance or approval,” the FDA wrote.
‘Our inspection… determined that the CBD Daye Tampon is adulterated … and is also misbranded … your firm did not notify FDA regarding changes and modifications that could significantly affect its safety or effectiveness.”
The warning letter discussed a series of communications between the company and the agency.
“FDA evaluated the regulatory decision form that you provided and found the assessment inadequate because the CBD coating raises significant concerns regarding the safety of the devices due to the potential for local and systemic exposure of CBD, potential adverse events (e.g., reproductive/developmental toxicity), and potential effects due to the uncertainty of the potency and quality of the CBD (e.g, from possible contaminants like Delta-9-tetrahydrocannabinol),” it said.
Milanova told Medpage Today the company was “actively working with the FDA” and had voluntarily removed the tampons from the US market.
However, the tampons were not the only Daye product with which the FDA had an issue. Agency officials also warned the company against marketing its vaginal microbiome screening kit to US customers, also describing it as adulterated.
“Your firm does not have an approved application for premarket approval … or an approved application for an investigational device exemption,” the FDA wrote.
“Your promotion is that the device is intended for diagnosing yeast infections, BV (bacterial vaginosis), STIs (sexually transmitted infections), fertility implications, and other gynaecological health complications, indications for which your firm lacks clearance or approval.”
Milanova said kts have been “validated for accuracy through randomised controlled clinical trials and are processed in a CLIA- and CAP-certified lab”.
She added: “We will continue collaborating with experts to ensure full compliance with FDA requirements.”
Medpage Today article – CBD-Coated Tampons? FDA Says No Way (Open access)
See more from MedicalBrief archives:
Toxic metals, including lead, found in tampons – US study
New ‘spiral’ tampon shape approved by FDA
CBD products don’t ease pain – UK, Canadian study