'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.'
Read more: $32,500 for CBD Oil?
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