Despite pressure from congress, senate majority leaders, industry stakeholders, and even the general public – it seems the FDA is making very little headway in terms of establishing regulations for the U.S. CBD market.
In a warning letter dated July 22, 2019, The FDA addressed multiple violations being committed by the company CuraLeaf. Does that name sound familiar to you? It should. It’s the company that secured a deal with CVS to sell CBD products in the pharmacy chain earlier this year. They were set to supply select products to over 800 stores nationwide, until this happened. In a swift response to this FDA fiasco, CVS already announced that they plan to pull CuraLeaf’s existing products off store shelves.
Following news of the warning letter, CuraLeaf’s stocks immediately plummeted by around 13%, although the have began to level out again over the last few hours. When Yahoo Finance reached to the company, they responded promptly: “CuraLeaf is fully committed to complying with FDA requirements for all of the products that it markets. We can reaffirm that nothing in the letter raises any issues concerning the safety of any CuraLeaf product.”
So, what exactly was in that letter? It was incredibly detailed, although it’s states in the letter itself that they didn’t address all the of violations observed and the responsibility would fall solely on CuraLeaf to make sure their website is fully compliant within the next 15 days.
In the letter, the FDA referred to CuraLeaf products as “unapproved and misbranded human drugs products.” They stated that various items listed for sale on their website are considered “drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.”
Some of the noted medical claims include using a CBD vape pen for chronic pain and inflammation, and using CBD oil for anxiety, depression, ADHD, and other mental health disorders. Let it be known that these warnings were in reference to both products that were for sale, as well as articles on the company’s blog. To find these claims, the FDA looked CuraLeaf’s company website and all of their social media accounts.
They also addressed the labeling of CBD as a dietary supplement. As per the letter, “Information on your (CuraLeaf’s) website and social media accounts suggests that you may intend to market your CBD products as dietary supplements… However, they cannot be dietary supplements because they do not meet the definition of a dietary supplement under sections 201(ff)(3)(B) and 201(ff)(2)(A)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B) and 321(ff)(2)(A)(i).”
“The FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition.”
They were also adamant about stifling claims made regarding pets and CBD. They targeted CuraLeaf’s ‘Bido CBD for Pets’ treats, as well as multiple articles which stated that CBD can benefit pets in many ways including relieving pain, minimizing anxiety, and reducing seizures. The FDA was having absolutely none of that.
“Because the products are intended to mitigate, treat, or prevent disease in animals, they are drugs within the meaning of section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B). Further, these products are “new animal drugs” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-l.”
In the letter, the FDA emphasized the fact that this letter is not an “all-inclusive” statement of violations, and that CuraLeaf has 15 days upon receipt to fix these and any other unlisted issues or they will face further legal action.
Follow this link to read the full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/curaleaf-inc-579289-07222019