As it happens.... you can search all clinical studies of CBD in humans at clinicaltrials.gov -- in theory, they should all be listed there. The FDA requested data on cannabis compounds in FDA regulated products over the summer and, as they stated last month, they got a lot of comments and not a lot of data (4,452 comments, very little data). GW Pharmaceuticals had, far and away, the best summation of CBD human clinical data in their FDA submission over the summer. https://www.regulations.gov/document?D=FDA-2019-N-1482-4257. They had to do randomized clinical trials to get their FDA approval of Epidiolex. Their data are also summarized on the FDA webpage, in their labeling, and published somewhere. I forget where. The Public Health Institute wrote a good, well reasoned analysis, focusing though on cannabis more broadly, https://www.regulations.gov/document?D=FDA-2019-N-1482-4054 They are very concerned about the more recent, more potent strains of marijuana and edibles that are appealing to children. When you review the comment by GW, you realize just how weak the data really are supporting other supposed benefits of CBD outside of its outstanding efficacy in treatment of certain seizure disorders**. But the best cases that could be put forth at least in the FDA docket on cannabis compounds in FDA-regulated products was by Dixie Brands, https://www.regulations.gov/document?D=FDA-2019-N-1482-4165 Aurora Cannabis was another one that was pretty thorough, if weak, https://www.regulations.gov/document?D=FDA-2019-N-1482-4240, maybe Vertical BioScience, https://www.regulations.gov/document?D=FDA-2019-N-1482-4250
The FDA has been more focused on safety of CBD as a regular component of the diet than what it actually does. There's probably support for a "general feeling of well being." And if there's enough THC in the product, that might produce a micro-dosing effect that would produce calming sensation or make you sleepy -- especially in a cannabis naive person.
** There are several reports of Sudden Unexpected Death in Epilepsy (SUDEP)in patients who stopped taking their regular meds to try over-the counter CBD products. That's bad. a full 60-70% of those products are mislabeled and don't contain the amount of CBD that's stated on the label.
Phew. I spend A LOT of time on weed from a regulated industry standpoint at the federal level.
no subject
The FDA requested data on cannabis compounds in FDA regulated products over the summer and, as they stated last month, they got a lot of comments and not a lot of data (4,452 comments, very little data).
GW Pharmaceuticals had, far and away, the best summation of CBD human clinical data in their FDA submission over the summer. https://www.regulations.gov/document?D=FDA-2019-N-1482-4257. They had to do randomized clinical trials to get their FDA approval of Epidiolex. Their data are also summarized on the FDA webpage, in their labeling, and published somewhere. I forget where.
The Public Health Institute wrote a good, well reasoned analysis, focusing though on cannabis more broadly, https://www.regulations.gov/document?D=FDA-2019-N-1482-4054 They are very concerned about the more recent, more potent strains of marijuana and edibles that are appealing to children.
When you review the comment by GW, you realize just how weak the data really are supporting other supposed benefits of CBD outside of its outstanding efficacy in treatment of certain seizure disorders**.
But the best cases that could be put forth at least in the FDA docket on cannabis compounds in FDA-regulated products was by Dixie Brands, https://www.regulations.gov/document?D=FDA-2019-N-1482-4165
Aurora Cannabis was another one that was pretty thorough, if weak, https://www.regulations.gov/document?D=FDA-2019-N-1482-4240, maybe Vertical BioScience, https://www.regulations.gov/document?D=FDA-2019-N-1482-4250
The FDA has been more focused on safety of CBD as a regular component of the diet than what it actually does. There's probably support for a "general feeling of well being." And if there's enough THC in the product, that might produce a micro-dosing effect that would produce calming sensation or make you sleepy -- especially in a cannabis naive person.
** There are several reports of Sudden Unexpected Death in Epilepsy (SUDEP)in patients who stopped taking their regular meds to try over-the counter CBD products. That's bad. a full 60-70% of those products are mislabeled and don't contain the amount of CBD that's stated on the label.
Phew. I spend A LOT of time on weed from a regulated industry standpoint at the federal level.