We must maintain consumer access to CBD oil, a safe, non-addictive,
natural pain treatment.
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 who holds drug market exclusivity requests FDA do so.
Unless we change the rules rules, we may see a government-sponsored monopoly on
CBD oil, and in the near future, on other cheap, safe, and effective
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 is unconscionable on a number of levels. We have an opioid epidemic in
this country that is killing 33,000 people a year, and growing. FDA-approved
drugs are part of the problem: fentanyl is as much as 100 times more powerful
than morphine and killed 4,200 people in 2014; aspirin causes internal
bleeding. There are also more than 100 million Americans with untreated pain.
How does the FDA look out for these patients? By denying them access to the
product so Big Pharma can make a killing selling it to these same patients at
an exorbitant price.
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.
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 save CBD oil
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP][Your Email]