Did GW Pharmaceuticals (GWPH) Just Destroy The CBD-Product Industry?

DISTRICT OF COLUMBIA:  The Food and Drug Administration (FDA) announced that products which contain cannabidiol (CBD) cannot be sold as dietary supplements. The agency, however, left open the possibility that would it consider contrary evidence.

The FDA’s website provides questions and answers pertaining its policies on marijuana. The way the questions were written provides avenues for addressing the agency’s view and for showing that cannabis-derived products that contain cannabidiol can be sold as a dietary supplement.

The FDA said that a substance authorized as a new drug for which clinical investigations had begun cannot be introduced in a dietary supplement. Although federal law carves out an exception for substances already in a dietary supplement prior to authorization of the investigational new drug (IND), the FDA determined the exception did not apply to CBD.

 

Marijuana Research Projects Getting State Funding

COLORADO:  Colorado was poised Wednesday to award more than $8 million for medical marijuana research, a step toward addressing complaints that little is known about pot’s medical potential.

The grants to be awarded by the state Board of Health would go to studies on whether marijuana helps treat epilepsy, brain tumors, Parkinson’s disease and post-traumatic stress disorder.

Though the awards are relatively small, they represent a new frontier for marijuana research. That’s because the Colorado grants are outside of the usual federal channels for approving marijuana research, a process that some say stymies pot research.

Federal approval to study marijuana’s medical potential requires permission of the Food and Drug Administration, the Drug Enforcement Administration and the National Institute on Drug Abuse. And there’s only one legal source of the weed, the Marijuana Research Project at the University of Mississippi.

The Government Wants To Buy 12 Acres Of Marijuana — For Research

DISTRICT OF COLUMBIA:  Calling all pot farmers: Uncle Sam is looking to buy.

An arm of the National Institutes of Health dedicated to researching drug abuse and addiction “intends” to solicit proposals from those who can “harvest, process, analyze, store and distribute” cannabis, according to a listing posted Tuesday night on a federal government website.

A successful bidder must possess a “secure and video monitored outdoor facility” capable of growing and processing 12 acres of marijuana, a 1,000-sq.-ft. (minimum) greenhouse to test the plants under controlled conditions, and “demonstrate the availability” of a vault approved by the Drug Enforcement Administration (DEA) and the Food and Drug Administration to maintain between 400 and 700 kg of pot stock, extract and cigarettes.

Back-up plans in case of emergency required.

 

Florida Medical Association Opposes Medical Marijuana

FLORIDA:

The Florida Medical Association, a statewide lobbying group for doctors, has announced that it “strongly” opposes the medical marijuana referendum going to voters in November.

In a statement released Monday, the group said it unanimously voted to oppose the measure at its annual conference in July. The resolution of opposition said marijuana should be “subject to the same standards” as other prescription drugs and be brought to market through the Food and Drug Administration’s process of testing and trials, not a political vote.

The group also rejected smoking as a way of taking a medication because it posed its own health hazards.

The FMA also said vague language in the ballot amendment “would allow healthcare providers with absolutely no training in the ordering of controlled substances, to order medical marijuana.”

 

Marijuana Considered for Looser Restrictions by U.S. FDA

DISTRICT OF COLUMBIA:  U.S. regulators are studying whether restrictions on marijuana should be eased, a step toward decriminalizing the drug at the federal level.

The Food and Drug Administration is conducting an analysis at the Drug Enforcement Administration’s request on whether the U.S. should downgrade the classification of marijuana as a Schedule 1 drug, said Douglas Throckmorton, Deputy Director for Regulatory Programs at the FDA, at a congressional hearing.

Schedule 1 drugs carry the most restrictions of the five DEA classifications and are considered substances with no medical benefit that are highly addictive. Factors the FDA considers in making a recommendation include a drug’s abuse potential, its pharmacological effect and risk to public health, according to Throckmorton’s written testimony.

“This has big implications,” said Representative John Mica, a Florida Republican, who is leading the oversight hearing on pot research as part of an examination of changing societal attitudes about the drug.