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.
Please close loophole that turns supplements into drugs
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP][Your Email]