(Epidiolex + Patent) × Schedule 1 = Cannabidiol (CBD) illegal to sell?

in medical •  3 years ago 

"It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement"
https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

"enforcing cannabis patents in federal district courts remains a grey area in the industry since cannabis is currently classified as a Schedule I drug."
https://www.patentdocs.org/2018/06/gw-pharmaceuticals-wins-fda-approval-of-first-cbd-drug.html

"Use of cannabinoids in the treatment of epilepsy
Patent 10,092,525
Issued: October 9, 2018
Assignee(s): GW Pharma Limited

The present disclosure relates to the use of cannabidiol (CBD) for the treatment of atonic seizures."
https://www.drugs.com/availability/generic-epidiolex.html

"Epidiolex is a drug marketed by Gw Res Ltd and is included in one NDA. There are sixteen patents protecting this drug.

This drug has one hundred and four patent family members in twenty-two countries.

The generic ingredient in EPIDIOLEX is cannabidiol. There are nine drug master file entries for this compound. One supplier is listed for this compound."
https://www.drugpatentwatch.com/p/tradename/EPIDIOLEX

"The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome."
https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms

"Among other things, it is currently illegal to put into interstate commerce a food to which CBD has been added, or to market CBD as, or in, a dietary supplement. Essentially, the relevant statutory provisions prohibit these uses of CBD because CBD was the subject of substantial clinical investigations into its potential medical uses before it was added to foods (including dietary supplements), and, separately, because CBD is the active ingredient in Epidiolex, an FDA-approved prescription drug product to treat rare, severe forms of epilepsy."
https://www.fda.gov/news-events/fda-voices/fda-committed-sound-science-based-policy-cbd

"The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application"
https://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-over-counter-cbd-products-pain-relief

FDA Warns Companies Illegally Selling CBD Products
https://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-cbd-products

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