Hemp-derived cannabis is everywhere whether states have legalized weed or not. Many state lawmakers are seeking to close loopholes left in the 2018 Farm Bill to put the kibosh on these massively under-regulated products. Meanwhile, the federal government is moving at its own pace to do the same.
The U.S. Food & Drug Administration (FDA) issued a second warning to Daye Tampons regarding its use of CBD. If left unaddressed, they will no longer import the products.
These tampons are produced in Bulgaria, but the business is based in London. The company is focused on vaginal health, selling products that cover period pain, hygiene, and vaginal health supplies. The CBD Tampons are one such product that boasts lab-tested cannabinoids, organic cotton, plastic-free, in renewable, ocean-safe packaging.
While these standards sound solid, the FDA has issued its second warning letter to the brand. According to the letter, Daye failed to inform the government that these tampons were coated in CBD.
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The addition of the cannabinoid pushes the product into the devices category as it is “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.”
In the letter, the FDA cites that Daye marketed and labeled the product as pain-relieving, which differs from what it was approved for. The product was licensed for vaginal insertion and discharge absorption, but this new use requires further safety and efficacy inspection from the FDA. The agency also cites a failure to log customer complaints warning about potential health risks.
The company had 15 days after receipt of the letter to respond with actionable points on how it will bring operations up to compliance. This would include changing packaging and marketing to reflect the product that was FDA approved. The brand informed GreenState that it voluntarily removed the CBD tampons from the U.S. market while figuring out how to make the product compliant and affordable.
“If our CBD Tampons are classified as drugs vs medical devices, this would significantly increase the cost to the final patient, making the innovation less accessible,” Daye said in a statement sent through its press team.
The company decided to pull the products from the U.S. market while the issue is resolved.
EDITOR’S NOTE: This article has been updated to include comment from Daye.
