The Rejection of This Marijuana Petition by the FDA Could Be a Bigger Deal Than You Realize
Suddenly, rescheduling cannabis doesn't seem like such a terrible idea.
Sean Williams
(
TMFUltraLong)
Jul 8, 2018 at 11:41AM
In just a few months, the legal cannabis industry will be
turned on its head. Based on the passage of the Cannabis Act on June 19 in Canada, adults will be able to legally purchase marijuana beginning Oct. 17, 2018. That's right -- Canada will be the first industrialized country in the world to give the green light to recreational marijuana.
And it's not just Canada that's seen a marked change in cannabis policy. To our south, Mexico legalized medical cannabis in June 2017. On a broader basis, more than 24 countries around the world have given the OK to medical cannabis in some capacity, be it for the dried product or via cannabis oils. At no point in history has momentum for legal weed ever been this strong.
Image source: Getty Images.
The U.S. federal government won't cave to peer pressure on marijuana
Yet in the U.S., the tale of legal cannabis is bifurcated, at best.
On one hand,
Oklahoma's recent approval makes it the 30th state to pass sweeping medical marijuana laws. Among these 30 states are nine that also allow adults to consume recreational cannabis. Further, a Gallup poll from October 2017 found that an all-time high 64% of respondents favor the legalization of marijuana.
On the other hand, the federal government continues to stand firm on its Schedule I classification of the drug. Schedule I drugs are entirely illegal, considered to be highly prone to abuse and have no recognized medical benefits.
This scheduling also can
create havoc for businesses and patients. For example, businesses in the pot industry are unable to take normal corporate income tax deductions and usually have little or no access to basic banking services. Meanwhile, patients who could potentially benefit from access to medical cannabis get the short end of the stick because federal red tape dramatically slows the clinical-research process.
The FDA recently has given cannabis enthusiasts two things to cheer about
For as strict as the federal government has been with classifying cannabis, the U.S. Food and Drug Administration (FDA) has delivered two big wins in as many weeks for the legal weed movement.
For those who may not recall, on June 25, the FDA approved
GW Pharmaceuticals' (
NASDAQ:GWPH) Epidiolex, which is the
first cannabis-derived drug to get a greenlight. Utilizing cannabidiol (CBD), the non-psychoactive cannabinoid most often associated with medical benefits, GW Pharmaceuticals' lead drug wound up delivering statistically significant reductions in seizure frequency relative to baseline and when compared to a placebo.
Image source: GW Pharmaceuticals.
The mere fact that the FDA granted GW Pharmaceuticals' cannabis-derived drug an approval is in direct conflict with the definition of a Schedule I drug, which has no recognized medical benefits. Thus, this approval could coerce Congress to review the scheduling of marijuana or, at worst, consider rescheduling CBD. After all, CBD is already legal in some capacity in 46 states. Therefore, legalizing specific cannabinoids for medical use, like CBD, probably wouldn't require a lot of string pulling.
Then earlier this past week, the FDA gave legalization enthusiasts something else to cheer about when it rejected a petition from Drug Watch International to place marijuana on a list of restricted substances. In particular, the anti-legalization group sought the removal of over-the-counter (OTC) drug products containing marijuana or tetrahydrocannabinol (THC), the psychoactive cannabinoid that gets you "high," from store shelves because the group felt that these OTC medicines were making unsupported medical claims.
However, as
reported by Forbes, Janet Woodcock, the Director of the FDA's Center for Drug Evaluation and Research, noted in a letter to the group that the FDA "already has adequate authority to remove unapproved new OTC drugs containing marijuana or THC from the market." Woodcock added: "In order for the FDA to take enforcement action against illegal marketing of unapproved new OTC drugs containing marijuana or THC, it is not necessary for FDA to establish a negative monograph for marijuana or THC."
In other words, no further restrictions are being placed on medical cannabis at the federal level than already exist.
Image source: Getty Images.
Refuting this petition is possibly a bigger deal than you realize
But what you may not realize is just how telling the FDA's decision is not to further restrict OTC marijuana and THC products.
One of the biggest conundrums that the medical cannabis industry is contending with in the U.S. is rescheduling the drug. Ideally, proponents would like to see marijuana removed completely from the controlled substance list, but this isn't likely to happen -- at least not while Republicans have control of the legislative branch of the government.
In various polls, self-identified Republicans usually have a
mixed or negative view of cannabis, albeit they usually are strongly behind the idea of physicians being able to prescribe medical marijuana to patients. This mixed-to-negative view toward marijuana probably means the best hope the legal weed industry has of taking a step forward at the federal level is by rescheduling it from Schedule I to Schedule II.
But herein lies the problem: Even though Schedule II drugs have recognized medical benefits, they also would come under the strict guidance of the FDA. This means the FDA would have the final say on marketing and packaging and it could oversee the manufacturing and processing of cannabis crops to ensure that THC and/or CBD content remained consistent from one batch to the next.
More importantly, it also could require medical marijuana companies to run costly and time-consuming clinical studies to backup their claims that cannabis helps patients with a specific ailment. I've
previously opined that this aspect of rescheduling could make things even worse for the pot industry than they are now.
However, the FDA's rejection of Drug Watch International's petition appears to suggest that the drug-regulatory agency may not take a line-in-the-sand approach should marijuana be rescheduled to Schedule II. This isn't to say that the FDA hasn't pursued enforcement actions against OTC-based marijuana and THC products, so much as to suggest that the regulatory agency probably wouldn't require extensive clinical studies to be run. That's good news for medical patients and U.S. cannabinoid-based drug developers, and it would appear to make the Schedule II classification far less scary for the marijuana industry.
There's clearly a lot left to be hashed out with marijuana in the U.S., but the push to reschedule looks to be gaining momentum.
Only dispensaries that are vertically integrated into the market will survive. That means being zoned for a kitchen to make edibles, having an extraction permit and lab onsite, cloning, garden supplies etc. The more you can do from seed to sale the better your chances of making it.
