WHY NOT THE FDA?
THE FDA IS NOT EQUIPPED TO REGULATE CANNABIS
The Food and Drug Administration (FDA) is, at its core, a consumer protection agency. It was created to monitor labels for food and drugs for accuracy and to ensure they are free from adulterants. For medicines, the power of monitoring labels evolved into evaluating health claims that led to the pathway for FDA drug approval. “FDA Approved” has become synonymous with “medicine” in US healthcare systems.
The current FDA drug approval process is based on the single path transduction model (“single-target/single-drug”), which has successfully delivered many valuable one-size-fits-all treatments to the public. In other words, the model is based on isolating a single compound (often from a plant) and standardizing it for prescription use. This method has been applied to “cannabinoids” found in the cannabis plant by isolating and even synthesizing single compounds; the result has been widely reported as subpar to the natural product, which is reflected in patient and medical professional preference for botanical cannabis in comparison to these limited prescription options.
The FDA currently lacks a clear pathway for approving and regulating botanical medicines like cannabis. It is disingenuous for the FDA to point to the “Botanical Drug Development Guidance for Industry” as a solution for cannabis medicines when, in the same document, they admit its limitation for “multi-target/multi-component” to achieve drug approval: “The Agency recognizes that demonstrating each botanical raw material’s contribution to safety and efficacy in a product with multiple botanical raw materials may not always be feasible.” This is also why, in the twenty years since the FDA released this guidance document, only three extractions have achieved drug approval, and all three could easily be categorized as single-compound therapeutics.
“The Agency recognizes the technical challenges in determining standard pharmacokinetic measurements of systemic exposure because a botanical drug product often consists of more than one chemical constituent and the active constituents may not be identified,” page 14.
“The clinical evaluation of botanical drugs in early-phase clinical studies does not differ significantly from that of synthetic or highly purified drugs in such studies (see21 CFR 314.126), page 15.
“For example, botanical drug products derived from a single source (e.g., American ginseng root) would not be considered a fixed combination drug product under the Fixed-Combination regulations because the entire botanical mixture generally is considered to be the active ingredient. The Agency recognizes that demonstrating each botanical raw material’s contribution to safety and efficacy in a product with multiple botanical raw materials may not always be feasible. In addition, the Agency believes that it is desirable to facilitate the development of natural source products that have been used in humans, thus the Agency has proposed revisions to the current Fixed-Combination regulations that would allow FDA to waive the combination rule requirements in certain situations.34 For example, the proposed rule envisions that botanical drug products composed of multiple botanical raw materials in fixed ratios (e.g., from multiple parts of the same plant or from parts of different plant species) could be considered for waiver, provided that there is prior human experience for the clinical use of such a combination,” page 22.
Medical cannabis requires a unique oversight structure that considers its botanical nature, varied formulations, and individualized usage. Creating an Office of Medical Cannabis and Cannabinoid Control (OMC) within HHS, separate from the FDA regulations and DEA oversight, would allow for a regulatory body dedicated to developing safety standards, research priorities, and patient access programs tailored to medical cannabis.
HEMP REGULATIONS & ADULT-USE LEGISLATIVE PROPOSALS JEOPARDIZE THE FUTURE OF MEDICAL CANNABIS
While the legalization of recreational cannabis (i.e., marijuana) and descheduling bills like the Cannabis Administration and Opportunity Act (COA) and the Marijuana Opportunity Reinvestment and Expungement (MORE) Act are still likely years away, Congress is feeling the immediate pressure to regulate hemp products after the 2018 Farm Bill legalized a market without fully defining hemp products. But handing off cannabis to the FDA, which has already admitted they don’t have the bandwidth or the model to properly regulate CBD, could prove to be a disastrous decision for the businesses as well as patients.
The Cannabinoid Safety & Regulation Act (CSRA), a recent legislative proposal to regulate hemp products, creates a dangerous path for cannabinoid regulations. Like legislative proposals for adult cannabis use, the bill proposes creating a center for cannabinoid products in the FDA, using language similar to the 2009 Tobacco Control Act, which made the Center for Tobacco Products and gave the FDA regulatory authority over tobacco.
Putting cannabis and cannabinoids under the FDA would reinforce roadblocks to cannabis’ future as a recognized medicine. While regulations for cannabis and hemp are paramount, misguided policies could place cannabis under unattainable FDA pharmaceutical regulations, putting patients back where they started 25 years ago, creating new barriers to access, and potentially a new illicit market.
We need only look at nicotine regulation for a cautionary example: since the FDA assumed control in 2009, smoking rates have declined, but vaping rates have soared unchecked. The FDA restricted flavored nicotine products and mandated registration for e-cigarette products, pledging not to approve flavored options that might appeal to youth. Yet despite these efforts, more flavored e-cigarette products than ever flood smoke shops, often bypassing legal channels and operating in an even less regulated space. If the FDA gains similar control over cannabis, expecting a different outcome would be unrealistic—especially in light of the complex history of cannabis prohibition.
These complex layers are crucial to understand and to press elected officials about policies that redefine medicine in the United States that would allow cannabis to be treated as a medicine and not pushed down the same bumpy path as nicotine products or stuck in an unrealistic pathway for medicine.
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