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The War Against Natural Medicines mean $32,500 for CBD Oil

CBD Is natural not man made, don't let FDA take it over for pharma

Original Article: April 6, 2018 (From ANH-USA)

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. Please send your message immediately.

Original Article

Important Steps

  1. Find your Congressional Representative. Use https://www.house.gov/representatives/find-your-representative to quickly find out who represents you
  2. Call them and lodge your complaint or concern about the possibility of the FDA taking away natural CBD and other forms from people such as yourself.
  3. Send letters to Congress. Let them know that drug companies SHOULD NOT HAVE the ability to stop access to CBD and other Cannabinoids.
  4. Share this article with friends and others. Use Facebook, Twitter, Tumblr, MeWe and others to share this important message.
  5. Use the Action Alert link here on this article. Lodge your concerns from multiple directions.

These steps need to be shared with OTHERS immediately. The more our representatives hear our voices, the more opportunity we have of protecting CBD and Cannabinoids from government control (read that as ownership of Big Pharma).

Big Pharma Could Come after your CBD

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US Farm Bill allows for Broader legalization of Hemp and products

What the Bill Reveals

In the Agricultural Act of 2014 (“Farm Bill”) regarding industrial hemp, the U.S. Department of Agriculture (USDA) and other organizations were given the "green light" to go ahead with pilot programs to allow for hemp to be sold. This led to the adoption by many States of pilot programs to permit growing of the hemp plants in their jurisdictions. This is what provides the lion's share of legal status for hemp and hemp products (such as CBD).

The term “industrial hemp” includes the plant Cannabis sativa L. and any part or derivative of such plant, including seeds of such plant, whether growing or not, that is used exclusively for industrial purposes (fiber and seed) with a tetrahydrocannabinols concentration of not more than 0.3 percent on a dry weight basis. The term “tetrahydrocannabinols” includes all isomers, acids, salts, and salts of isomers of tetrahydrocannabinols.

Every five years, Congress passes legislation that sets national agriculture, nutrition, conservation, and forestry policy, commonly referred to as the “Farm Bill”. In this year's version, many amendments (as will happen with our Congress) were added. The one with the real teeth was Mitch McConnell's amendment. This one more openly allows for Hemp legalization (far more than allowed under the 2014 Farm Bill). Although the final passage of this bill has not hit the goal line with the House's version, many are hopeful that it will so it can be signed quickly into law by President Donald Trump.