Comment from Song No

I respectfully submit this comment regarding FDA’s guidance document, Cannabis and Cannabis‑Derived Compounds: Quality Considerations for Clinical Research. This comment addresses a structural regulatory issue that materially affects FDA, DEA, HHS, DOT, and all federal agencies relying on FDA’s scientific determinations regarding cannabis. 1. FDA’s Current Framework Creates a Regulatory Deadlock Under the existing interpretation, FDA evaluates cannabis exclusively through the drug‑approval pathway, requiring: A single active ingredient A stable, reproducible formulation Controlled pharmacokinetics Drug‑level clinical trials Cannabis, as a multi‑compound botanical, cannot meet these requirements. This creates a closed regulatory loop: DEA relies on FDA to determine “accepted medical use.” FDA relies on drug‑approval standards that cannabis cannot satisfy. As a result, neither agency can resolve cannabis scheduling. This loop has persisted for decades and prevents the establishment of a coherent federal regulatory framework. 2. FDA Is Already Regulating Cannabis Under DSHEA FDA’s own docket materials demonstrate that cannabis is already being evaluated as a dietary ingredient under the Dietary Supplement Health and Education Act (DSHEA). Specifically: FDA‑2025‑S‑0023‑0107 (FDA response letter) FDA‑2025‑S‑0023‑0108 (NDI Notification 1425 – Cannabis sativa L. Essential Oil) These documents confirm that: FDA has accepted Cannabis sativa L. essential oil as a New Dietary Ingredient (NDI) submission. FDA reviewed this submission under DSHEA, not the drug‑approval pathway. FDA did not reject the submission on the basis of CSA scheduling. FDA treated cannabis as a botanical dietary ingredient, consistent with other multi‑compound botanicals. This establishes a clear regulatory precedent: Cannabis is compatible with DSHEA and can be regulated as a botanical dietary supplement. 3. Scientific Basis for DSHEA Classification Cannabis exhibits the defining characteristics of a botanical dietary ingredient: It contains multiple active constituents (cannabinoids, terpenes, flavonoids). Its effects arise from synergistic interactions rather than a single active molecule. Its pharmacokinetics vary by cultivar, preparation, and route of administration. It is widely used for structure/function effects (sleep, mood, appetite, inflammation). These characteristics align with DSHEA’s botanical framework and are incompatible with FDA’s drug‑approval standards. 4. Requested Revision to FDA Guidance Given the evidence above, I respectfully request that FDA revise the guidance to: A. Acknowledge that cannabis may be regulated as a botanical dietary ingredient under DSHEA. This aligns with FDA’s existing treatment of Cannabis sativa L. essential oil in NDI 1425. B. Clarify that cannabis is not limited to the drug‑approval pathway. This removes the structural barrier preventing federal agencies from resolving cannabis scheduling. C. Recognize that medical use may occur through licensed professional recommendation. This is consistent with DSHEA’s treatment of botanicals with therapeutic applications (e.g., St. John’s Wort, valerian, kava). D. Update the guidance to reflect FDA’s existing DSHEA cannabis precedent. This ensures internal consistency across FDA regulatory actions. 5. Federal Harmonization and Public Health Benefits Recognizing cannabis as a botanical dietary ingredient would: Provide a scientifically coherent regulatory home Break the FDA–DEA scheduling deadlock Enable consistent federal policy across agencies Improve product safety through GMP and labeling standards Support research without requiring drug‑approval constraints Allow DOT and other agencies to modernize impairment‑based policies This approach aligns with FDA’s statutory authority and existing regulatory practice. Conclusion FDA’s own NDI docket materials demonstrate that cannabis is already being evaluated as a botanical dietary ingredient under DSHEA. The current guidance document does not reflect this reality and perpetuates a regulatory loop that no agency can resolve. A formal acknowledgment within this guidance that cannabis may be regulated under DSHEA is necessary to establish a coherent, scientifically grounded federal framework. It provides an established, governing body and will alleviate a major roadblock in employment in safety sensitive sectors.