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FDA Takes Action on Unauthorised CBD Products
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The Week In Cannabis: Epidiolex, Casa Verde, FDA, Michigan, Colombia, And More
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GW Pharmaceuticals plc (NASDAQ:GWPH) published positive results for its Phase 3 clinical trial of Epidiolex oral solution in seizures related to tuberous sclerosis complex in JAMA Neurology. Epidiolex is the first FDA-authorized CBD medicine for children with severe forms of epilepsy. The medicine was first approved for treatments of seizures connected to Lennox-Gastaut syndrome and Dravet syndrome.
Michigan Gov.
Gretchen Whitmer commuted the sentence of Last Prisoner Project’s constituent Michael Thompson, who spent 25 years in prison after a 1994 arrest of a nonviolent cannabis sale.
“I’m thankful to everybody that was involved and I’m thankful to Gov. Whitmer for granting my freedom. It’s been a hard journey but I’m just thankful that no one gave up on me. I want to use my time to help those who can’t help themselves and work for criminal justice reform,” said Thompson.
The U.S. Food and Drug Administration warned five companies on Tuesday to stop selling CBD products the agency said violate the Federal Food, Drug, and Cosmetic Act.
The regulatory body issued warning letters to Bee Delightful; G&L Wellness (C Better Daily); New Leaf Pharmaceuticals; NextL3vel Services Group, LLC, doing business as This Stuff Is Good For You; and Wellness BioSciences.
None of the products addressed in the letters underwent its drug approval process, the FDA said.
The concerns are raised around the route of the product s administration, as well as the using CBD as a food additive and marketing CBD products as dietary supplements.
FDA issues warning letters to companies illegally selling unapproved CBD products
Today, the U.S. Food and Drug Administration issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). All five warning letters address the illegal marketing of unapproved CBD products claiming to treat medical conditions. The warning letters include CBD products that are especially concerning from a public health perspective due to the route of administration, including nasal, ophthalmic and inhalation. In addition, they address violations relating to the addition of CBD to food, and the impermissible marketing of CBD products as dietary supplements. Two of the letters also address CBD products illegally marketed for pets, including a product for use in the eye.
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