FDA: Curaleaf claims to have developed products that can treat a wide range of diseases, including cancer, Alzheimer's, Parkinson's, depression, opioid withdrawal syndrome, chronic pain, anxiety, post-traumatic stress disorder, and attention deficit/hyperactivity disorder (ADHD).
According to the company, it has products that supposedly treat anxiety and diabetes in cats and dogs. (The product comes in bacon and salmon flavors.)
The single ingredient responsible for all of the above is a hemp-derived cannabinoid compound (CBD).
Unfortunately, these claims are not supported by evidence.
This week, the Food and Drug Administration (FDA) announced that it had sent Curaleaf a warning letter for illegally selling unapproved drugs and disclosing them as therapeutic products.
These claims that products containing CBD can treat serious diseases and conditions “may put patients and consumers at risk by leading them to postpone important medical care,” said Ned Sharpless, FDA commissioner.
In addition, there are many unanswered questions from science about the safety, efficacy, and quality of unapproved products containing CBD.
The legal landscape is unclear
The ingredient CBD is a relatively safe component of cannabis that appears to have no risks of addiction and does not get you “high.”.
In addition, it has been shown that it can have a sedative effect, but also help with epileptic seizures.
Last June, the FDA approved Epidiolex, the first CBD-based drug, to help treat two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. However, the substance cannot be called a cure because it does not treat the cause but combats the symptom. Sedative yes, therapeutic no.
At the time of FDA approval, the Drug Enforcement Administration (DEA) considered CBD a Schedule I drug, in the same category as cannabis, heroin, and LSD. With the FDA approval of Epidiolex, it was removed from the DEA list.
However, there still seem to be gaps in the legal framework.
The FDA, on the other hand, says it will create a “high-level internal working group to investigate the various types of CBD products that can be legally marketed.”
The organization not only tries to collect scientific data on the effects of CBD but also to create appropriate regulations for safety, marketing, labeling, and quality control.
As for Curaleaf, the company said it “strives to have the highest standards of quality and compliance and will work with the FDA to resolve all issues raised in the letter.”
He has 15 working days to do so.
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