FDA Wants to Turn CBD Oil Into a Drug that Will Cost $32,500 as They Ban all Other CBD Oils

Source If we don’t change a key FDA policy, that’s how much you may be forced to pay if you want to purchase CBD oil. Action Alert!

For years, consumers have benefitted from access to cheap, safe, and effective CBD oil supplements. But now the FDA says that CBD is a drug, not a supplement—a drug which will be sold for $32,500 a year.

Legally the FDA could at any time remove all CBD supplements from the market, on its own volition, or if the drug company which holds drug market exclusivity requests FDA do so. Unless we change the rules, we may see a government-sponsored monopoly on CBD oil, and in the near future, additional monopolies on other cheap, safe, and effective supplements.

This is happening because of a back-channel that allows natural supplements to be turned into drugs by the FDA.

It works like this: if a company is investigating a substance as a drug, FDA rules give the company market exclusivity on that substance—even if it is currently being sold as a supplement.

There are two exceptions: if the supplement was “marketed in or as a dietary supplement” before 1994, or if a supplement company has filed a “new supplement” notification with the FDA before the company’s investigation began. (Recall, too, that the FDA has not completed the policies for submitting a “new supplement” notification, so supplement companies don’t even know how to comply!) Pyridoxamine, an important form of vitamin B6 was removed from the market by the FDA through this exact same mechanism.

This means that, at any time, GW Pharmaceuticals, the manufacturer of the CBD drug, can ask the FDA to remove cheap CBD oil supplements from the market, and the only option consumers will have is their new drug that costs $32,500 a year.

This hasn’t happened yet, but we think GW is simply waiting for the market for CBD oil to grow—which it is. When it reaches a tipping point, then GW can ask the FDA to remove all the CBD supplements, and wait for the cash to roll in from consumers who don’t have any other choice.

This threat to affordable CBD oil shows how broken this system is.

An opioid epidemic is ravaging our country, with drug overdose deaths surpassing car accident fatalities.

People are addicted to and dying from FDA-approved drugs, yet the agency is poised to eliminate consumer access to a non-addictive, cheap, safe, and effective alternative in CBD oil—all so one drug company can charge tens of thousands of dollars for what currently costs a few dollars.

The Senate Farm Bill took one step to protect CBD oil by legalizing the growth of hemp (though it remains to be seen if the final bill will contain this language), but that alone will not preserve consumer access to this important medicine.

ANH-USA is crafting legislation that will, among other things, protect CBD oil and other natural substances from being turned into drugs by eliminating the market exclusivity that drug companies get when a new drug investigation is on a dietary ingredient currently being sold in the market in a dietary supplement.

These rules should apply retroactively to protect CBD oil and other substances that have already (or are likely to be) removed before this legislation becomes law.

Until we close this loophole, we will see drug companies continue to turn our natural dietary supplements into drugs. News headlines are filled with Phase II or Phase III drug trials failing; Big Pharma is in search of a sure thing, and what could be better than supplements that have demonstrated health benefits?

The FDA will not protect us—they’re in on it! More drugs mean more user fees—more money—for the agency, so don’t expect the FDA to defend your access to supplements.

Action Alert! Write to Congress and the FDA and tell them you support a legislative change that eliminates market exclusivity for INDs filed on substances that are currently sold in the market as dietary supplements.

Read the full article at ANH-USA.org.

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Study: 86% patients had seizure reduction while using artisanal cannabis

Screen Shot 2018-11-15 at 11.58.37 AMIn a study of 272 patients, 86% had some degree of seizure reduction while using artisanal cannabis. A combination of cannabinoids and terpenes — not just CBD — may be most effective for seizures.

These clinical findings challenge Big Pharma assumptions that favor single-molecule medications.

 

Read the entire article at Project CBD

Add Marijuana Prohibition to the List of Proven Conspiracies?

From Estamio2 on Reddit

The point comes up that lot of bad medicine was practiced in the 19th Century. Mercury, cocaine and Heroin were prescribed. Cocaine and “Heroin” do have medicinal uses today, but their use is now a Strawman Argument to suggest marijuana-as-medicine is equally quacked.

Inquiry into various substances in the 1800s allowed the emergence of all medicine today, along with the disuse of less effective (or dangerous) drugs. Key is honest scientific inquiry.

I think the fact that marijuana was prescribed as medicine in the 1880s, whether-or-not it was sharing shelves with mercury, proves the Conspiracy of Cannabis Prohibition. It’s use should have been pursued, if it worked.

Because if it is being legitimately (scientifically) pursued, it proves its efficacy as medicine (alleviates symptoms).

The Conspiracy is further proven by the agenda-driven renaming “Cannabis”, “Marijuana” to racially stigmatize the substance. By unscientific demonization by Harry Anslinger along with sensationalized newspaper headlines associating MJ use with crimes.

The excessive, unreasonable and cruel incrimination during the 20th Century is a Conspiracy.

(Hearst-paper lobbyists>Government officials>Law enforcement>Propaganda-influenced public)

Medical Conditions That Can Be Treated With Cannabis: A – Z

Alcohol and opiate abuse

Cannabis can ease both the physical and psychological effects associated with withdrawal from both of these addictive substances.
Cannabis-med studies on marijuana treatment for alcohol and drug abuse
Marijuana in treating alcohol addiction
Medical marijuana as a treatment for alcohol addiction

Alzheimer’s disease

Research shows that cannabis may prevent the formation of deposits in the brain associated with this degenerative disease.
Information from medicalmarijuana.procon.org
Cannabis and the treatment of dementia
Cannabidiol: a promising drug for neurodegenerative disorders?

Neurodegeneration is a feature common to dementia sufferers.
This has led to interest in whether cannabinoids may be clinically useful in the treatment of people with dementia.

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An Open Letter To Jeff Sessions From A Doctor Whose Patients Rely On Medical Marijuana

By Dr. David Bearman – huffingtonpost.com


Dear Sen. Sessions,

Let me start by introducing myself. I am Dr. David Bearman, I am considered to be one of the most clinically knowledgable physicians in the field of medical cannabis in the United States. I have spent 40 years working in substance and drug abuse treatment and prevention programs. I was a pioneer in the free and community clinics that are now available to Americans everywhere. I was even a member of then-California Governor Ronald Reagan’s Interagency Task Force on Drug Abuse. I urge you, if confirmed, to take medical cannabis seriously and not only allow state programs to continue to flourish but urge the president, the DEA, Congress and FDA to work on seriously reconsidering America’s current drug laws and policies.

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Michigan: 1st State in Midwest to Legalize Recreational Marijuana; Missouri and Utah Approve Medical Marijuana

(plus this):

 

from Drug Policy

Press Release

Michigan voters approved Proposal 1, a ballot initiative to legalize, regulate and tax marijuana for adults 21 and over, making it the 10th U.S. state to legalize marijuana – and the first in the Midwest. Missouri and Utah also became the 32nd and 33rd states to approve medical marijuana.
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Only 13% Of Doctors Learn Up To Date Info On Medical Cannabis

Patrick Dewals

A close-up photo of a high-end cannabis bud, covered in crystals and tiny hairs. August 22, 2013. (Flickr / Don Goofy)

My search for an expert opinion on medicinal cannabis (MC) brings me to California. Since 1996, following a referendum, medicinal cannabis is legal in the sunny U.S. state. It is estimated that there are already more than one million California patients that use MC.
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