Tell Congress: Close the FDA Back-Channel

For years, consumers have benefitted from access to cheap, safe, and effective CBD oil and L-glutamine 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 who holds drug market exclusivity requests FDA do so. A newly approved drug means L-glutamine faces a similar threat.

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 only a few exceptions to this rule.

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 GW could simply be 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.

The same goes for L-glutamine, a supplement that can be bought for $10 a bottle; the drug, Endari, will reportedly cost $40,000 a year.

We need legislation that protects CBD oil, L-glutamine, 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 as a dietary supplement. These rules should apply retroactively to protect CBD oil and other substances like pyridoxamine 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 our access to supplements.

Write to the FDA and Congress and tell them that they must protect consumer access to cheap CBD oil, and should champion efforts to change the rules so supplements can't be turned into drugs.

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Food and Drug Administration

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Please close loophole that turns supplements into drugs

Dear [Decision Maker],

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For years, consumers have benefited from access to cheap, safe, and effective CBD oil and L-glutamine 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 who holds drug market exclusivity requests FDA do so. A newly approved drug means L-glutamine faces a similar threat.

The same goes for L-glutamine, a supplement that can be bought for $10 a bottle; the drug, Endari, will reportedly cost $40,000 a year.

Please protect consumer access to cheap CBD oil and champion efforts to protect supplements from being turned into drugs.

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]
[Your Email]