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To: NobleFree

Under the same rigor as the FDA that a pharmaceutical company is required to do? That is the standard for releasing a drug. If it’s not the standard for medical pot, then why? It seems that certain extracts have been approved but pot itself has not been.

This is from the FDA website.

2. Why hasn’t the FDA approved marijuana for medical uses?

A. To date, the FDA has not approved a marketing application for marijuana for any indication. The FDA generally evaluates research conducted by manufacturers and other scientific investigators. Our role, as laid out in the Federal Food, Drug, and Cosmetic (FD&C) Act, is to review data submitted to the FDA in an application for approval to assure that the drug product meets the statutory standards for approval.

The FDA has approved Epidiolex, which contains a purified drug substance cannabidiol, one of more than 80 active chemicals in marijuana, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. That means the FDA has concluded that this particular drug product is safe and effective for its intended indication.

The agency also has approved Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in AIDS patients. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC) which is considered the psychoactive component of marijuana. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.


28 posted on 08/19/2018 6:34:17 AM PDT by Dutch Boy
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To: Dutch Boy
Under the same rigor as the FDA that a pharmaceutical company is required to do? That is the standard for releasing a drug. If it’s not the standard for medical pot, then why?

FDA standards are arguably overly stringent; a number of well regarded pharmaceuticals that are legal in Europe have been rejected by the FDA, and it's often said that existing drugs like aspirin couldn't pass FDA screening today.

And if the pot stays within a single state, it's Constitutionally none of any federal agency's business anyway.

46 posted on 08/19/2018 11:31:18 AM PDT by NobleFree ("law is often but the tyrant's will, and always so when it violates the right of an individual")
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