FDA
FDA issues warning to tampon manufacturer for significant violations
FDA issued a warning letter to Anne's Daye Ltd, doing business as Tampon Innovations, for significant violations of manufacturing practices. The inspection revealed multiple deficiencies, including failure to establish and maintain procedures for quality control, inadequate documentation of manufacturing processes, and lack of proper testing protocols.
These violations, which include concerns about CBD-infused tampons, could lead to the production of tampons that don't meet safety and efficacy standards. Potential issues include local and systemic exposure to CBD, possible adverse events such as reproductive or developmental toxicity, and uncertainties regarding the potency and quality of the CBD, including potential psychoactive effects from contaminants like Delta-9-tetrahydrocannabinol.
The agency also noted concerns regarding the company's vaginal microbiome screening kits. These kits, intended for diagnosing and monitoring vaginal health, were found to lack proper validation and quality control measures. The absence of these protocols raises questions about the reliability and accuracy of the test results, potentially impacting patient care and treatment decisions.
FDA. (2024, December 17). Warning Letter: Anne’s Daye Ltd dba Tampon Innovations. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/annes-daye-ltd-dba-tampon-innovations-696362-12172024