What Would Cannabis Legalization Look Like After the 2018 Midterm Elections?
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What Would Cannabis Legalization Look Like After the 2018 Midterm Elections?

Columns - Technically Speaking

The federal status of marijuana is a messy, old issue that now exists in a new political context.

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Federal agencies have discussed and litigated the matter of cannabis legalization for decades, and while many bills have even been introduced in Congress, no legislation regarding cannabis’s general legal status has ever made significant progress. The result: Cannabis in 2019 remains a Schedule I substance under the Controlled Substances Act, effectively making clinical research studies impossible.

The Joyce Amendment (formerly the Rohrabacher-Blumenauer Amendment), which prohibits the spending of federal funds in a manner that interferes with state medical marijuana programs in which delta-9-tetrahydrocannabinol (THC) is allowed, has been noteworthy, and one of the few federal boons for the industry. The stalemate between marijuana’s advocates and the political foot soldiers of the war on drugs is clear: This amendment is the only federal government directive the industry has had for the better part of a decade.

This year’s new political context is one in which, first of all, 33 states approve medical or adult-use marijuana programs and 13 others approve only cannabidiol (CBD) programs, demonstrating strong voter support for the issue, and, second, the Democrats control the House of Representatives and have a meaningful (47-53) position in the Senate.

Given this political climate, U.S. Rep. Earl Blumenauer’s (D-OR) latest recommendations for legalization (outlined in his “Blueprint to Legalize Marijuana in the 116th Congress” memo released on Oct. 17, 2018) are extremely appropriate. It would be advisable that the Democrat-controlled House pass any reasonable legislative offer from the Senate regarding cannabis legalization.

One should note, however, that government actions—legislative or administrative—to legalize the plant could easily make things worse for producers, processors, retailers and patients if the actions do not simultaneously address both the longstanding legislative and administrative issues that we have faced.

Look at what happened with the legal status of hemp after the Farm Bill became law on Dec. 20, 2018. Although the bill removed hemp from the Controlled Substances Act’s Schedule I prohibitions (which include forbidding clinical research and the ability for doctors to formally prescribe the drug to patients), the law provided no exception to the regulation of hemp-derived chemical compounds by the Food and Drug Administration (FDA). And so, on the day that the Farm Bill became law, the FDA restated its position that under the agency’s longstanding rules, hemp-derived CBD cannot be sold in the U.S. as a food or supplement, or without appropriate clinical investigations as a drug. (Because CBD is listed as an active ingredient in the FDA-approved drug Epidiolex, it is subject to that clinical trial mandate. The FDA does not allow active drug ingredients to be sold separately from their pharmaceutical formulation, regardless of where the compound stands in the eyes of the U.S. Department of Justice.)

So, while the Farm Bill legalized the production of hemp, it also left the sale of hemp-derived CBD in the gray market. (However, the FDA is planning to hold a hearing on CBD policy in April.)

The anticipated resistance from Senate Republicans (and potentially a few red-state Democrats) on marijuana legalization, however, can be expected to take the same form as it did with hemp in the Farm Bill. It would be pointless to simply reschedule marijuana into Schedule II without further guidance. From there, like the current situation with CBD, prior to authorizing any sales, the FDA would invite us to begin clinical trials (which easily could take 10 years to complete and would paralyze the industry for that time).

The clearest way for CBD to leave this gray zone may be through marijuana legislation that covers all cannabinoids, including THC.

Political Path Forward

Cannabis industry members recognize that meaningful agency action in lifting barriers and requirements is highly unlikely, and that truly significant congressional action will be required to affect this type of change. Several new pieces of marijuana legislation, such as the STATES Act, already have been introduced in the House of Representatives. The most significant of these would resemble the 21st Amendment, which repealed prohibition on beverage alcohol. Such a law would allow the states to regulate marijuana in the same way that the states have regulated beverage alcohol since 1933.

Simply moving marijuana from Schedule I into any other schedule leaves the FDA free to maintain the status quo in which marijuana that is legal under state law could face federal legal challenges. Under current FDA rules, all Schedule II to Schedule IV drugs are subject to FDA regulation, which begin with the requirement of clinical trials to verify health benefit claims.

Placing marijuana firmly under the control of the states, however, would avoid the severe problems that we could otherwise expect from the FDA.

A Necessary Relationship

With respect to the regulation of marijuana, the past 50 years have left most federal agencies, including the FDA, with a gross lack of credibility and legitimacy. Nevertheless, the FDA otherwise holds a very positive position in American society. Beyond keeping misbranded and adulterated drugs off the American market and giving Americans confidence in the products that they find on American store shelves, the FDA has the credibility to offer Americans education on the health impacts of certain products.

Once federal agencies become less antagonistic toward the cannabis industry, it would be to our advantage to align ourselves with these government agencies (FDA, Department of Agriculture, Department of Commerce, etc.) if we hope to be trusted.

However, given the federal history with respect to cannabis, it is difficult to anticipate that federal agencies might play a rational role in regulating this industry without clear congressional leadership. Our best hope remains in Democratic leadership from the House that would make an offer to the Senate to place cannabinoids under state control. The FDA’s role in controlling explicit pharmaceutical claims might then be negotiated. Only then might we emerge from the federal quagmire regarding basic legality like the beverage alcohol industry did in 1933, which, in our opinion, would be OK.

Just as important, we might begin to repair the damage done not only to the American people, but to the legitimacy of the federal government and its drug policy.

Thomas Schultz President, Connecticut Pharmaceutical Solutions (CPS), CTPharma.com

Rino Ferrarese COO, Connecticut Pharmaceutical Solutions