A lawsuit has been filed against CBD company Koi CBD citing a violation of the federal law.
Plaintiffs Calley Fausett and Leigh Good sued Koi in California federal court.
The FDA accused the company of intentionally marketing and selling illegal products.
It comes after the Administration sent 15 warning letters to companies for illegally selling a variety of FDA-regulated products, including Koi. In the letters, the agency requested responses from the companies within 15 days stating how they planned to correct the violations. If not – legal action was threatened.
The lawsuit against Koi is a direct result of those letters.
Although a full list of regulations on CBD products has still not been released, the FDA has made it very clear which products it deems illegal.
Since the CBD boom when Farm Bill was passed in 2018, the use of the hemp derivative has been adopted by over 64 million Americans.
Most of those users stand by the non-psychoactive therapeutic effects of the drug – including its so-called ability to relieve pain, improve skin, and stop anxiety.
Companies that claim its products could be used to treat medical conditions or diseases such as Crohn’s disease, post-traumatic stress, multiple sclerosis, and various cancers are strictly off-limits.
In the letter sent to Koi owner Brad Ridenour back on November 22, a number of its products were called out.
It said the company needed to ‘take orders’ for its CBD healing balm, vape oil, full-spectrum tincture, lotion, gummies, three varieties of ‘shots’, pet spray, and animal chews.
The letter added: “The claims on your website establish that your ‘CBD healing balm,’ ‘CBD vape oil,’ ‘full-spectrum CBD tincture,’ ‘Koi lotion,’ ‘Koi CBD gummies,’ and ‘Koi CBD infused shot’ products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d).
The FDA also said Koi’s products were ‘misbranded drugs’ under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1) and its pet products were ‘unapproved new animal drugs that are unsafe’.
A webpage titled ‘8 proven benefits of CBD’ claimed ‘CBD relieves pain and inflammation’ and ‘lowers incidence of diabetes’. The FDA said these claims established the products as drugs.
Koi’s website, which names itself as ‘the #1 trusted brand’ of a variety of CBD products, appears to no longer have a visible blog page as of December 18.
The lawsuit is one of many being filed as a result of the FDA’s letters sent a couple of weeks ago.
In a statement upon the release of the warnings, FDA Principal Deputy Commissioner Amy Abernethy said, “As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns.”
“In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate.”
At a time when the health association is struggling to regulate the products, this move seems to be a step in the right direction – although a recent study from Penn medicine revealed that up to 70% of cannabidiol extracts could be mislabeled.
After studying a group of 84 products from 31 companies, researchers found that 42 percent of products were under-labeled, meaning that the product contained a higher concentration of CBD than indicated. Another 26 were categorized as ‘over labeled – meaning the product did not contain as much CBD as was labeled on the packaging.