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FDA Chief Considers Federal Cannabis Reform An “Inevitability”

By Alexander Beadle
Published: Dec 03, 2018   
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In a recent appearance on CNBC, the Food and Drug Administration (FDA) Commissioner Scott Gottlieb hinted that federal action on cannabis policy is inevitable and can be expected to happen soon.

Gottlieb did not elaborate on exactly what action could be anticipated, but he did indicate that there is “probably going to be a policy reckoning around this at some point in the future.” The Commissioner’s comments will undoubtedly be felt in the cannabis industry as a suggestion that federal decriminalization or even federal legalization could be on the cards.

“Obviously it’s happening at the state level, and I think there’s an inevitability that it’s going to happen at the federal level at some point soon,” said Gottlieb.

A possible explanation for the commissioner’s comments

The topic of conversation in the interview quickly transitioned to talking more generally about drug pricing issues, thus leaving the Commissioner’s comments on cannabis policy open to interpretation.

It could be that the implied federal action is in reference to a tightening of existing cannabis prohibition or some sort of stricter enforcement of current marijuana laws. This would certainly please some of the more conservative politicians in the Republican establishment, including Vice-President Mike Pence who has opposed the legalization of cannabis use in every state-level and federal office he has held.

Alternatively, the Commissioner’s comments could also be interpreted as hinting that there is sufficient support in Congress for a bipartisan bill that would amend portions of the Controlled Substances Act to exempt state-legal cannabis activity from its provisions. A bipartisan bill fitting this description was introduced in July by Sens. Elizabeth Warren (D-MA) and Cory Gardner (R-CO), and the legislation has already been backed by President Donald Trump. The bill, titled The Strengthening the Tenth Amendment Through Entrusting States (STATES) Act, has been read twice in the Senate and referred to the Committee on the Judiciary, but at present has not progressed further.

Following the televised interview, the online cannabis news outlet Marijuana Moment contacted the FDA for clarification on Gottlieb’s comments, but was told by an FDA spokesperson “unfortunately I don’t have anything additional to share” in response to the inquiry.

The FDA and medicinal cannabis

When questioned by co-anchor Joe Kernen about something concerning recreational cannabis, Gottlieb responded saying that recreational cannabis doesn’t “fall within our purview right now”.

“But look, we do regulate compounds that are making drug claims and we regulate botanical use of marijuana,” said Gottlieb. “We have approved compounds derived from marijuana, but there is no demonstrated medical use of botanical marijuana. That’s the bottom line.”

Whole plant cannabis has actually been shown to exhibit unique medicinal properties due to synergistic interaction between the medicinal cannabinoids and other terpenoids that are present in whole cannabis flowers (this is known as the entourage effect); but given the brevity of the interview and the fact that cannabis plants remain federally illegal, it is understandable why the FDA Commissioner would not emphasize this.

The FDA is indeed responsible for regulating drug claims, and in that vein the FDA did recently approve a drug derived from cannabis plants for use after it was clinically proven to be effective in three randomized, double-blind, placebo-controlled studies. That drug is Epidiolex, a therapeutic designed for suppressing epileptic seizures in patients with Lennox-Gastaut syndrome and Dravet syndrome, which contains cannabidiol (CBD) as its main active ingredient. Following this move by the FDA, the Drug Enforcement Agency (DEA) rescheduled the status of FDA-approved CBD drugs to Schedule V to reflect CBD's medicinal properties and negligible potential for abuse, putting it on par with some forms of cough medicine and antidiarrheals.

Taking this move by the FDA in conjunction with earlier personal public statements from Commissioner Gottlieb where he supported the federal decriminalization of cannabis, many will be hoping that the commissioner’s comments signal a continuation in the FDA’s recognition of cannabis medicine.

What if America did end cannabis prohibition?

It’s extremely unlikely that the Commissioner’s comments indicate any plans to federally legalize both medicinal and recreational cannabis use, as has happened in Uruguay and Canada, but with the increasing recognition of cannabis’ medicinal properties, negligible abuse risk, and a growing public support for legalizing the drug, it is important to identify how America would change if total cannabis reform was achieved.

According to both the Cato Institute and New Frontier Data, a legalization scenario in which cannabis products are fairly taxed under the standard business tax rate could generate over $105 billion in annual budgetary gains for federal, state, and local governments. The report from New Frontier Data also forecasts that up to 1 million new jobs would be created over an 8-year period following this legalization scenario.

Some advocacy groups also believe that complete legalization would ease the burden on the nation’s courts and criminal justice system. According to the National Organization for the Reform of Marijuana Laws (NORML), cannabis-related arrests make up 6% of all arrests and 7% of felony court convictions in the United States. With so much time and money going towards the prosecution of these nonviolent drug crimes - then the added expense of looking after incarcerated drug offenders - legalizing cannabis could save billions in taxpayer dollars as well as help tackle the growing issue of prison overcrowding.


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