Marijuana Moment reports
The Food and Drug Administration (FDA) is warning the manufacturer of a CBD tampon that its allegedly “adulterated” product is not approved for sale in the U.S. and is currently being “misbranded” due to the addition of the cannabinoid.
Daye tampons, from the company Anne’s Daye, were cleared by FDA “for insertion into the vagina to absorb menstrual discharge,” the agency said in a warning letter last month. But it asserts that the company “did not notify FDA regarding changes and modifications in the device that could significantly affect the safety or effectiveness of the device.”
“As we have communicated to you,” the new December 17 letter says, the company’s FDA “clearance is for only the Daye Tampon and not for a CBD coated Daye Tampon.”
Officials also pointed to marketing claims around the CBD tampons that it said go beyond what FDA had approved. “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,” the letter says.
Full report at
FDA Warns CBD Tampon Company Over Allegedly ‘Misbranded’ And ‘Adulterated’ Products
