FDA: Curaleaf claims to have developed products that can cure too many diseases such as cancer, Alzheimer's, Parkinson's, depression, opioid withdrawal syndrome, chronic pain, anxiety, post-traumatic stress disorder, attention deficit / hyperactivity disorder (ADHD).
According to the company, it has products that are supposed to treat stress, and diabetes in cats and dogs. (This product comes in bacon and salmon flavors.)
The only ingredient responsible for all of the above is a cannabis-derived cannabis (CBD).
Unfortunately, these claims are not supported by evidence.
This week, the Food and Drug Administration (FDA) he said that he sent Curaleaf a letter of formal notice for the illegal sale of unauthorized medicinal products and their disposal as therapeutic products.
These claims that CBD-containing products can cure serious illnesses and conditions "could endanger patients and consumers by leading them to delay significant medical care," said Fed Commissioner Ned Sharpless.
In addition, there are many unanswered questions from science about the safety, efficacy and quality of unauthorized CBD-containing products.
Cloudy the legal landscape
The CBD ingredient is a relatively safe ingredient in cannabis that seems to have no addictive risks and does not put you in a "high" state.
In addition, it has been shown to be able to have sedative action, but also to help with seizures.
Last June, the FDA approved Epidiolex as the first CBD-based drug to help with two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients aged two years and older. However, the substance can not be called therapeutic as it does not cure the cause but fights the symptom. Soothing yes, healing no.
At the time of FDA approval, the Drug Enforcement Department (DEA) considered the CBD a Program I drug and was in the same category as cannabis, heroin and LSD. With the approval of Epidiolex by the FDA, it was removed from the DEA list.
However, there still appear to be gaps in the legal framework.
The FDA says it will set up a "high-level internal working group to investigate the various types of CBD products to be legally marketed."
The organization seeks not only to collect scientific data on the effects of CBD but also to establish appropriate regulations for safety, marketing, labeling and quality control.
Regarding Curaleaf, the company stated that it "strives to have the highest standards of quality and compliance and will work with the FDA to resolve any issues raised in the letter."
He has 15 business days to do it.
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